YL-201: A Novel B7-H3-Targeting Antibody-Drug Conjugate for Solid Tumor Therapy

I. Executive Summary

YL-201 is an investigational antibody-drug conjugate (ADC) engineered by MediLink Therapeutics, targeting B7-homologue 3 (B7-H3), a protein frequently overexpressed on various cancer cells. The therapeutic is built upon MediLink's proprietary Tumor Microenvironment Activable LINker (TMALIN®) technology platform, which facilitates the site-specific conjugation of a potent topoisomerase I inhibitor payload. This innovative platform is designed to enhance the therapeutic window by ensuring payload stability in circulation and promoting targeted release within the tumor microenvironment and cancer cells.

Clinical investigations have demonstrated notable anti-tumor activity for YL-201, particularly in heavily pre-treated patient populations with Small Cell Lung Cancer (SCLC) and Nasopharyngeal Carcinoma (NPC). Data presented from Phase I/II studies have shown substantial overall response rates and encouraging progression-free survival in these challenging indications.[1] The safety profile of YL-201 appears manageable, characterized primarily by hematological toxicities, with a notably low incidence of severe non-hematological adverse events such as interstitial lung disease (ILD).[1]

The promising clinical profile of YL-201 has garnered significant regulatory attention. It has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for SCLC and Breakthrough Therapy Designations from China's National Medical Products Administration (NMPA) for both SCLC and NPC.[4] These designations underscore its potential to address substantial unmet medical needs and may expedite its development and review pathways. Furthermore, YL-201 is being actively explored in combination regimens with other anti-cancer agents, including immune checkpoint inhibitors and other targeted therapies, through strategic collaborations with major pharmaceutical companies.[7] The collective evidence suggests YL-201 holds considerable promise as a future therapeutic option, potentially as a monotherapy and a cornerstone of combination treatments for various solid tumors expressing B7-H3. The progression into pivotal Phase III trials for SCLC and NPC is a testament to the confidence in its therapeutic potential, which could redefine treatment paradigms for these difficult-to-treat malignancies.[4]

The advanced ADC technology embodied by YL-201, particularly its TMALIN® platform, appears to confer distinct advantages, contributing to its efficacy and safety. This is reflected not only in its clinical performance but also in the dual regulatory recognition from the US and China, which points to a robust dataset and a clear development trajectory. The rapid advancement to pivotal trials and the keen interest from established pharmaceutical entities for collaborative development further signal strong confidence from both the developer and the wider industry. This positions YL-201 as a potentially transformative therapy that could establish a new standard for B7-H3-targeted treatments.

II. Introduction to YL-201

A. Background on YL-201

YL-201, also referred to as YL201 or YL 201, is an investigational antibody-drug conjugate currently under clinical development.[11] It is being developed by MediLink Therapeutics (Suzhou) Co., Ltd., a clinical-stage biotechnology company with a dedicated focus on creating innovative conjugated drug therapies for global patient populations.[4] MediLink Therapeutics, founded in 2020, has operations in Suzhou and Boston, with subsidiaries in Shanghai and Singapore, aiming to address unmet medical needs through its proprietary technologies.[4]

B. The B7-H3 Target: Rationale in Oncology

The therapeutic strategy of YL-201 is centered on targeting B7-homologue 3 (B7-H3), also known as CD276. B7-H3 is a type I transmembrane glycoprotein belonging to the B7 family of immune checkpoint proteins.[12] Its expression profile makes it a compelling target for cancer therapy; B7-H3 is found to be overexpressed on a wide array of malignant cells, including cancer-initiating cells, across diverse tumor types such as Small Cell Lung Cancer (SCLC), Nasopharyngeal Carcinoma (NPC), and Non-Small Cell Lung Cancer (NSCLC).[1] Crucially, its expression in normal, healthy tissues is restricted, offering a potential for tumor-selective drug delivery.[4]

Beyond its expression pattern, B7-H3 plays a significant role in cancer progression. It is implicated in promoting tumor cell proliferation, facilitating metastasis, and contributing to the development of therapeutic resistance.[13] Furthermore, B7-H3 functions as a negative regulator of T-cell activation, thereby contributing to an immunosuppressive tumor microenvironment.[12] This dual functionality—directly supporting tumor growth and mediating immune evasion—enhances its attractiveness as an ADC target. An ADC directed against B7-H3, such as YL-201, could therefore exert anti-tumor effects not only through the cytotoxic payload but also potentially by modulating the tumor's interaction with the immune system. The widespread expression of B7-H3 across numerous solid malignancies also suggests a broad applicability for YL-201, potentially extending beyond its current primary indications of SCLC and NPC, and positioning it as a candidate for pan-tumor investigation, a notion supported by reports of "pan-tumor benefits" from early clinical studies.[1]

III. Mechanism of Action and the TMALIN® Technology Platform

A. YL-201 Construct: Antibody, Payload, and Linker

YL-201 is meticulously designed as an ADC, comprising three key components: a monoclonal antibody, a cytotoxic payload, and a specialized linker. The antibody component is engineered for high specificity in targeting the B7-H3 protein expressed on tumor cells.[4] This antibody is site-specifically conjugated to YL0010014, a potent topoisomerase I inhibitor payload, which exerts its anti-cancer effect by disrupting DNA replication and inducing cell death.[12] Connecting the antibody and the payload is the proprietary Tumor Microenvironment Activable LINker (TMALIN®), developed by MediLink Therapeutics.[4] This linker is central to the ADC's functionality and differentiated profile.

B. The Proprietary TMALIN® Platform

The TMALIN® platform is a cornerstone of MediLink Therapeutics' ADC development strategy and represents a significant technological advancement in the field.[4] It is designed to overcome several limitations associated with earlier generations of ADCs by incorporating multiple innovative features:

1. Dual Cleavage Mechanism: A distinguishing characteristic of the TMALIN® linker is its susceptibility to cleavage by two distinct mechanisms. It can be cleaved extracellularly within the tumor microenvironment (TME), which is often characterized by specific enzymatic activity, and also intracellularly within the lysosomes of cancer cells following internalization of the ADC.[15] This dual-release strategy aims to maximize payload delivery to tumor cells and potentially exert bystander effects on adjacent tumor cells, which could be particularly beneficial in treating heterogeneous tumors or those with inefficient ADC internalization. This contrasts with many traditional ADCs that rely solely on intracellular lysosomal degradation for payload release.
2. High Homogeneity and Drug-to-Antibody Ratio (DAR): The TMALIN® technology enables the production of highly homogeneous ADC products with a consistent and optimized drug-to-antibody ratio (DAR), with examples such as a DAR of 8 being noted.[4] This homogeneity is crucial for ensuring predictable pharmacokinetic behavior, consistent efficacy, and a manageable safety profile, as variability in DAR can lead to inconsistent clinical outcomes. Achieving a high DAR with such uniformity signifies advanced bioconjugation chemistry and manufacturing control.
3. Enhanced Physicochemical Properties: ADCs developed using the TMALIN® platform, including YL-201, are characterized by high water solubility and excellent plasma stability.[15] High plasma stability is critical for minimizing the premature release of the cytotoxic payload into systemic circulation, thereby reducing the potential for off-target toxicities. Data from other TMALIN®-based ADCs, such as YL217, have shown minimal payload release in circulation in non-human primate studies, underscoring the linker's stability.[18]
4. Specific Tumor Accumulation and Payload Release: The platform is engineered to facilitate the enrichment of the ADC in tumor tissues and ensure specific payload release predominantly at the tumor site.[15] This targeted delivery is fundamental to maximizing anti-tumor efficacy while sparing healthy tissues.
5. Augmented Therapeutic Window: Collectively, these features—dual cleavage, homogeneity, stability, and tumor-specific release—are designed to widen the therapeutic window of the ADC. This means achieving a better balance between potent anti-tumor activity and acceptable tolerability for patients.[4] The low incidence of severe non-hematological toxicities, particularly the remarkably low rate of treatment-related interstitial lung disease (ILD) observed with YL-201 [1], may be a direct consequence of the TMALIN® platform's sophisticated design, effectively sequestering the potent payload until it reaches its intended target.

The TMALIN® platform's capabilities extend beyond YL-201, as evidenced by MediLink's collaborations to develop other ADC candidates targeting different antigens, such as LRRC15 with Zai Lab and HER3 with BioNTech.[16] This external validation underscores the platform's robustness and versatility as a foundational technology for next-generation ADCs.

IV. Preclinical Profile

The preclinical evaluation of YL-201 provided the foundational evidence for its advancement into clinical trials. Studies demonstrated significant anti-tumor efficacy across a range of in vivo cancer models. Specifically, YL-201 showed promising activity in models of non-small cell lung cancer, prostate cancer, and esophageal squamous cell carcinoma, supporting the broad potential of targeting B7-H3.[11]

In addition to efficacy, preclinical toxicology studies in non-human primates (NHPs) indicated that YL-201 possesses good tolerability.[11] This early safety signal in NHPs, combined with the general characteristics of ADCs derived from the TMALIN® platform—which have consistently shown significant therapeutic windows in preclinical efficacy and toxicology assessments [16]—was encouraging. For instance, YL217, another ADC developed using the TMALIN® platform, not only demonstrated superior efficacy in various xenograft models but also exhibited high stability in NHP circulation with minimal premature payload release.[18]

These preclinical findings, showcasing both potent anti-tumor activity in diverse cancer types and a favorable safety profile in higher species, provided a strong rationale for investigating YL-201 in human clinical trials. The observed efficacy across different tumor models also supported the initial clinical development strategy of evaluating YL-201 in "basket" trials encompassing a variety of advanced solid tumors, rather than limiting investigation to a single malignancy from the outset. The consistent NHP tolerability and high in vivo stability seen with TMALIN®-based ADCs were important early indicators that foreshadowed the manageable safety profile later observed in clinical studies with YL-201.

V. Clinical Development Program

The clinical development of YL-201 is extensive, encompassing multiple Phase I, Phase II, and pivotal Phase III trials conducted globally, with significant activity in China and the United States.[1] This broad program aims to evaluate YL-201's efficacy and safety as a monotherapy and in combination regimens across various B7-H3-expressing solid tumors.

Table 1: Overview of Key YL-201 Clinical Trials

Trial ID (NCT #)	Phase	Target Indication(s)	Brief Description/Objectives	Key Endpoints (Primary)	Current Status (as of latest info)	Sponsor(s)
NCT05434234	Phase 1	Advanced Solid Tumors	Dose escalation and expansion to evaluate safety, PK, and preliminary efficacy of YL201 monotherapy in China and US.	MTD/RP2D, Safety, ORR	Active, Data presented	MediLink Therapeutics
NCT06057922	Phase 1	Advanced Solid Tumors	Similar to NCT05434234, exploring safety and efficacy of YL201 monotherapy.	MTD/RP2D, Safety, ORR	Active, Data presented	MediLink Therapeutics
NCT06612151	Phase 3	Relapsed Small Cell Lung Cancer (SCLC)	Randomized, open-label, comparing YL201 vs. Topotecan in relapsed SCLC.	Overall Survival (OS)	Recruiting	MediLink Therapeutics
NCT06629597	Phase 3	Recurrent/Metastatic Nasopharyngeal Carcinoma (NPC)	Randomized, comparing YL201 vs. Investigator's choice of chemotherapy in R/M NPC post PD-(L)1 inhibitors and ≥2 chemo lines.	OS, ORR (by BICR)	Recruiting	MediLink Therapeutics
NCT06394414	Phase 1	Advanced Solid Tumors (NPC, SCLC, NSCLC, etc.)	Dose escalation and cohort expansion of YL201 + serplulimab +/- platinum chemo in China.	MTD/RP2D(s) of combination, Safety, ORR	Recruiting	MediLink Therapeutics
NCT06898957	Phase 1b	Extensive-Stage Small Cell Lung Cancer (ES-SCLC)	Open-label, evaluating YL201 + Tarlatamab (IMDELLTRA™) +/- anti-PD-(L)1 in ES-SCLC. Dose exploration, expansion, and triplet combination.	Safety, Tolerability, MTD/RP2D of combination	Recruiting	Amgen (MediLink provides YL201)
YL201-INT-101-01	Phase 1	Advanced Solid Tumors	First-in-human study in US/China.	Safety, MTD/RP2D	Recruiting	MediLink Therapeutics

MTD: Maximum Tolerated Dose; RP2D: Recommended Phase 2 Dose; PK: Pharmacokinetics; ORR: Overall Response Rate; OS: Overall Survival; BICR: Blinded Independent Central Review.

Status and dates are based on available information and may be subject to change.

A. Small Cell Lung Cancer (SCLC)

SCLC is an aggressive malignancy with a generally poor prognosis, particularly in the extensive-stage (ES-SCLC) setting. The standard first-line treatment for ES-SCLC typically involves platinum-based chemotherapy (etoposide) combined with an immune checkpoint inhibitor such as atezolizumab or durvalumab.[19] However, upon relapse, treatment options are limited, and efficacy is often modest. Approved agents for relapsed SCLC include topotecan and lurbinectedin, with other regimens like paclitaxel or irinotecan also considered.[19] This landscape highlights a significant unmet medical need for more effective therapies in relapsed SCLC.

Phase I/II Monotherapy Data (ESMO 2024)

Data from the Phase I dose escalation and expansion studies (NCT05434234 & NCT06057922), presented at the European Society for Medical Oncology (ESMO) Congress in 2024, revealed promising activity for YL-201 in patients with ES-SCLC.1 The SCLC cohort included 79 enrolled patients (72 evaluable for efficacy), virtually all of whom had received prior platinum-based chemotherapy, and 95% had also been treated with anti-PD-(L)1 therapy, indicating a heavily pre-treated and typically refractory population.1

At the recommended expansion doses of 2.0 mg/kg and 2.4 mg/kg, YL-201 demonstrated:

• Overall Response Rate (ORR): 68.1% across all dose levels, and 70.0% for patients receiving doses ≥2.0 mg/kg.[1]
• Median Progression-Free Survival (mPFS): 6.2 months for patients receiving doses ≥2.0 mg/kg.[1]
• Disease Control Rate (DCR): 91.7% in the SCLC cohort.[3]
• Activity in Brain Metastases: In SCLC patients with brain metastases, the ORR was 52.2%, and mPFS was 5.3 months.[1]

These efficacy results are particularly noteworthy given the patient population. An ORR exceeding 60-70% and an mPFS of over 6 months in SCLC patients who have progressed after both platinum chemotherapy and immunotherapy suggest that YL-201 employs a mechanism of action that is distinct from, and not cross-resistant with, these prior treatments. This is crucial for a patient group with few effective alternatives. The observed activity against brain metastases is also a significant finding, as CNS involvement is common in SCLC and often associated with a poor prognosis; many systemic therapies have limited efficacy in the brain due to poor penetration of the blood-brain barrier. If YL-201 consistently demonstrates CNS activity, it could offer a substantial benefit for these patients.

Pivotal Phase III Trial (NCT06612151)

Building on the encouraging Phase I/II results, a pivotal Phase III trial (YL201-CN-SCLC-301; NCT06612151) has been initiated to definitively assess YL-201 in relapsed SCLC.9 This multicenter, randomized, controlled, open-label study is comparing the efficacy and safety of YL-201 against topotecan hydrochloride, a standard comparator in this setting.9

• Design: Patients are randomized to receive YL-201 administered intravenously every 3 weeks (Q3W) at the recommended Phase III dose (RP3D) or topotecan hydrochloride per its prescribing information.[9]
• Patient Population: Eligible patients are adults (aged ≥18 and ≤75 years) with an ECOG performance status of 0 or 1, histologically or cytologically confirmed SCLC, who have experienced disease progression on or after at least two cycles of first-line platinum-based therapy. Patients must have at least one measurable lesion and be willing to provide tumor tissue for B7-H3 expression analysis.[9]
• Primary Objective: The primary endpoint is to compare Overall Survival (OS) between the YL-201 and topotecan arms.[9]
• Secondary Objectives: Include comparisons of investigator-assessed PFS, ORR, Duration of Response (DoR), Time to Response (TTR), and DCR. The study will also further evaluate the safety, pharmacokinetics, and immunogenicity of YL-201, and explore the correlation between B7-H3 expression levels and clinical efficacy.[9]
• Status: The trial is currently recruiting participants, primarily in China, with an estimated study duration from December 2024 to November 2030.[9]

The initiation of this Phase III trial, along with the granting of Breakthrough Therapy Designation by the NMPA and Orphan Drug Designation by the FDA for YL-201 in SCLC [4], was directly propelled by the strength of the earlier clinical data. These regulatory recognitions are granted based on preliminary evidence suggesting a substantial improvement over available therapies for serious conditions and serve to expedite the drug's development and review processes.

B. Nasopharyngeal Carcinoma (NPC)

Nasopharyngeal Carcinoma is a type of head and neck cancer with a distinct geographical prevalence, being more common in parts of Asia. For patients with recurrent or metastatic (R/M) NPC, particularly those who have progressed after platinum-based chemotherapy and PD-1 inhibitors (a standard first-line approach for R/M disease being toripalimab plus cisplatin and gemcitabine [21]), subsequent treatment options are limited and often yield suboptimal outcomes.[6] This underscores a pressing need for novel, effective therapies in the later-line settings for R/M NPC.

Phase I/II Monotherapy Data (ESMO 2024)

The same Phase I/II studies (NCT05434234 & NCT06057922) that provided SCLC data also included a cohort of 75 enrolled NPC patients (70 evaluable for efficacy).1 Many of these patients were heavily pre-treated, having received at least two prior lines of therapy.2

Key efficacy findings for YL-201 monotherapy in NPC included:

• ORR: 48.6% for patients receiving doses ≥2.0 mg/kg. In the heavily pre-treated subgroup (≥2 prior lines), the ORR was 51.0%.[1]
• mPFS: 7.2 months for patients receiving doses ≥2.0 mg/kg. In the heavily pre-treated subgroup, mPFS was 7.0 months.[1]
• Activity by Histology: Notably, in patients with lymphoepithelioma-like carcinoma (LELC), a common histological subtype of NPC, the ORR was 60.9%.[14] For adenocarcinoma, the ORR was 29.2%.[14]

These results are clinically meaningful, demonstrating substantial anti-tumor activity in R/M NPC patients who have exhausted standard therapies. An ORR of approximately 50% and an mPFS of around 7 months in this setting offer hope for a patient population with a poor prognosis.

Pivotal Phase III Trial (NCT06629597)

Based on these encouraging early results, a pivotal Phase III trial (YL201-CN-NPC-301; NCT06629597) is underway to evaluate YL-201 in patients with R/M NPC.10

• Design: This is a randomized study comparing YL-201 with the investigator's choice of chemotherapy (options include docetaxel, capecitabine, or gemcitabine). Patients are eligible if they have failed prior treatment with a PD-(L)1 inhibitor and at least two lines of chemotherapy.[10] YL-201 is administered intravenously Q3W at the RP3D.[10]
• Patient Population: Adults (aged ≥18 and ≤75 years) with ECOG PS 0 or 1, histologically or cytologically confirmed R/M NPC not amenable to curative treatment, who meet the prior therapy failure criteria, are suitable for investigator's choice chemotherapy, have at least one measurable lesion, and are willing to provide tumor tissue for B7-H3 analysis.[10]
• Primary Objectives: The co-primary objectives are to assess whether YL-201 prolongs OS and increases ORR as assessed by Blinded Independent Central Review (BICR) compared to the investigator's choice of chemotherapy.[10]
• Secondary Objectives: Include further evaluation of efficacy (PFS, DoR, TTR, DCR), safety, pharmacokinetics, immunogenicity of YL-201, and the correlation between B7-H3 expression and clinical outcomes.[10]
• Status: The trial is actively recruiting participants, with its details posted in October 2024.[10] An investigator meeting for this Phase III study was held, indicating active progress.[15]

The NMPA's decision to grant Breakthrough Therapy Designation for YL-201 in R/M NPC, even before Phase III results are available, underscores the strength of the early clinical signal and the significant unmet medical need, particularly in China where NPC incidence is relatively high.[5] This designation may facilitate an accelerated approval pathway in China, potentially bringing this novel therapy to patients sooner.

C. Other Advanced Solid Tumors

Beyond SCLC and NPC, YL-201 is being broadly investigated for its potential across a spectrum of advanced solid tumors, reflecting the widespread expression of its target, B7-H3. The initial Phase I/II studies (NCT05434234 and NCT06057922) were designed as "basket" trials, enrolling patients with various tumor types who had exhausted standard therapeutic options.[1]

As of August 2024, these studies had enrolled 312 patients across multiple tumor types, including SCLC, NPC, and non-small cell lung cancer (NSCLC) without actionable genomic alterations (AGA).[1] Across this diverse and heavily pre-treated population (60% had received at least two prior treatment lines [1]), YL-201 demonstrated an overall ORR of 44.6% and a DCR of 83.7%.[1] The median follow-up was 5.4 months, with 46% of patients remaining on treatment at the time of data cutoff.[1] The recommended expansion doses were determined to be 2.0 mg/kg and 2.4 mg/kg Q3W.[1] These "pan-tumor benefits" suggest that B7-H3 is indeed a clinically relevant target for YL-201 across a range of malignancies, validating the initial rationale for broad exploration.

General inclusion criteria for these early-phase studies typically involve patients with pathologically confirmed advanced solid tumors for whom prior standard treatments were ineffective or intolerable, or for whom no standard therapy exists. Patients generally need an ECOG performance status of 0 or 1, adequate organ function, and a life expectancy of at least 3 months.[9] Exclusion criteria often include recent prior systemic anti-cancer therapies, uncontrolled brain metastases (though treated and stable metastases may be allowed), significant uncontrolled comorbidities (cardiovascular, pulmonary), and active viral infections like HBV, HCV, or HIV.[10]

The strategy of conducting these initial Phase I trials in both China and the US reflects a global development approach from an early stage.[1] This facilitates broader patient access, potentially accelerates data generation, and allows for simultaneous engagement with multiple regulatory authorities, which can streamline overall development timelines and prepare for multi-regional market access.

D. Combination Therapy Studies

Recognizing that combination strategies often lead to enhanced anti-tumor effects and can overcome resistance, MediLink Therapeutics is actively exploring YL-201 in conjunction with other anti-cancer agents. Preclinical data have suggested synergistic potential for such combinations.[7] This approach is common for promising ADCs, aiming to improve efficacy and broaden their applicability, potentially by leveraging ADC-induced immunogenic cell death to enhance the activity of immunotherapies.

YL-201 with IMDELLTRA™ (Tarlatamab, Amgen) in ES-SCLC (NCT06898957):

A significant collaboration is with Amgen to evaluate YL-201 in combination with IMDELLTRA™ (tarlatamab), a DLL3-targeting Bispecific T-cell Engager (BiTE®) molecule.8 IMDELLTRA™ received accelerated FDA approval for ES-SCLC patients who have progressed on or after platinum-based chemotherapy.2

• Design: This global, multi-center, open-label Phase Ib study (NCT06898957), led by Amgen, will assess the safety, tolerability, pharmacokinetics, and efficacy of the combination in ES-SCLC patients.[8] The study is structured in three parts:
• Part 1: Dose exploration of YL201 combined with a fixed dose of tarlatamab.
• Part 2: Dose expansion at the selected maximum tolerated combination dose (MTCD) or recommended Phase 2 dose (RP2D).
• Part 3: Evaluation of a triplet combination of YL201, tarlatamab, and an anti-PD-(L)1 inhibitor (atezolizumab or durvalumab) in first-line ES-SCLC patients who have received no more than one cycle of platinum-based chemotherapy, etoposide, and a PD-(L)1 inhibitor.[24]
• Status: The trial is actively recruiting, with its details posted in March 2025.[20]

This collaboration is particularly ambitious, especially the triplet therapy arm in the first-line maintenance setting for ES-SCLC. It suggests a long-term vision to potentially establish a new, highly active (and possibly chemotherapy-sparing or enhancing) regimen for a disease with historically grim outcomes, aiming to significantly shift the treatment paradigm.

YL-201 with Durvalumab (AstraZeneca) in Solid Tumors:

MediLink has also entered into a clinical collaboration with AstraZeneca to explore YL-201 in combination with durvalumab (Imfinzi®), an anti-PD-L1 immune checkpoint inhibitor.5

• Design: This multicenter, open-label, Phase I/Ib study will evaluate the safety, efficacy, and pharmacokinetics of the YL201-durvalumab combination in patients with various solid tumors.[7]
• Rationale: Durvalumab is approved for several solid tumors, and preclinical studies have indicated synergy between YL201 and durvalumab.[7] This combination seeks to leverage ADC-mediated tumor cell killing and antigen release with PD-L1 blockade to enhance anti-tumor immune responses.

YL201 with Serplulimab +/- Platinum-based Chemotherapy (NCT06394414):

Another combination study (NCT06394414) is being conducted in China, evaluating YL201 with serplulimab, a PD-1 inhibitor, with or without platinum-based chemotherapy.25

• Design: This Phase 1 study includes a dose-escalation part followed by a cohort expansion part in selected advanced solid tumors, including NPC, SCLC, and NSCLC.[25] This trial aims to identify optimal combination regimens, potentially tailored for the patient population in China.

These diverse combination trials underscore a strategic effort to position YL-201 as a versatile therapeutic agent, capable of augmenting the efficacy of current standard-of-care treatments and novel immunotherapies across a range of cancers.

E. Overall Safety and Tolerability Profile

The safety and tolerability of YL-201 have been evaluated in over 300 patients in the Phase I/II studies, with comprehensive data presented at ESMO 2024.1

During dose escalation, dose-limiting toxicities (DLTs) were observed at 2.8 mg/kg (one patient) and 3.0 mg/kg (two patients), leading to the determination of 2.8 mg/kg as the maximum tolerated dose (MTD).1 The recommended expansion doses were selected as 2.0 mg/kg and 2.4 mg/kg administered every three weeks.1

Table 2: Common Treatment-Related Adverse Events (TRAEs) with YL-201 (ESMO 2024 data, n=312)

Adverse Event	Grade ≥3 Frequency (%)
Hematological
Leukopenia	29 - 31.7%
Anemia	22 - 25.0%
Neutropenia	30 - 31.7%
Non-Hematological
Decreased Appetite	1%
Nausea	1%
Interstitial Lung Disease (ILD) / Pneumonitis	~1% (3 patients)

Source: [1]

The most frequently reported Grade ≥3 treatment-related adverse events (TRAEs) were hematological in nature:

• Leukopenia: 29% [14] to 31.7% [3]
• Anemia: 22% [14] to 25.0% [3]
• Neutropenia: 30% [14] to 31.7% [3]

These hematological toxicities are commonly associated with topoisomerase I inhibitor payloads and are generally considered manageable with standard supportive care, such as growth factor support or dose modifications.

Non-hematological TRAEs of Grade ≥3 were infrequent, with decreased appetite and nausea each reported in only 1% of patients.[1] A particularly important finding is the low incidence of treatment-related interstitial lung disease (ILD) or pneumonitis, which was observed in only 3 patients (approximately 1% to 1.3%).[1] ILD is a potentially serious toxicity associated with some ADCs, and this low rate for YL-201 is a very favorable safety signal.

Serious TRAEs were reported in 28% of patients.[14] Treatment discontinuations due to adverse events occurred in a relatively small proportion of patients (5.4%), and dose reductions due to AEs were required in 17.0% of patients, primarily due to manageable hematological toxicities.[3] Treatment-related infusion reactions were rare (0.3%).[3]

Overall, the safety profile of YL-201 appears manageable, especially considering the advanced and heavily pre-treated patient populations in these early trials. The predominantly hematological nature of severe toxicities, coupled with the low rates of severe non-hematological events and ILD, supports the notion that the TMALIN® platform contributes to an improved therapeutic window. This favorable safety profile is a critical attribute, particularly for its potential use in combination therapies where overlapping toxicities can be a major concern.

VI. Regulatory Status and Designations

YL-201 has achieved significant regulatory milestones in key global markets, reflecting its promising early clinical data and potential to address unmet medical needs in serious oncological conditions.

A. U.S. Food and Drug Administration (FDA)

The FDA cleared the Investigational New Drug (IND) application for YL201 in April 2022, which permitted the initiation of clinical trials in the United States.11 This marked an important step in the global development program for YL-201.

Subsequently, in December 2024, the FDA granted Orphan-Drug Designation (ODD) to YL201 for the treatment of Small Cell Lung Cancer (SCLC).4 ODD is granted to drugs intended for rare diseases or conditions and provides various incentives to the sponsor, including potential market exclusivity for a period upon approval, tax credits for qualified clinical trials, and exemption from FDA application fees. This designation acknowledges the significant unmet need for effective therapies in SCLC.

B. China National Medical Products Administration (NMPA)

In China, YL-201 has received two Breakthrough Therapy Designations (BTDs) from the Center for Drug Evaluation (CDE) of the NMPA.

• The first BTD was granted for the treatment of recurrent Small Cell Lung Cancer.[6]
• A second BTD was granted in January 2025 for the treatment of recurrent/metastatic Nasopharyngeal Carcinoma (R/M NPC).[5]

The BTD program in China is designed to accelerate the development and review of innovative drugs that demonstrate substantial clinical benefit over existing therapies for serious or life-threatening diseases. These designations provide YL-201 with an expedited review status by the CDE, allowing for more timely communication and potentially faster approval pathways.[16] The granting of BTDs for both SCLC and NPC underscores the strength of the preliminary clinical evidence and the urgency to bring potentially transformative treatments to these patient populations in China, where NPC, in particular, has a higher incidence.

C. European Medicines Agency (EMA)

Currently, specific information regarding filings or designations for YL-201 with the European Medicines Agency (EMA) was not found in the provided materials.[26] This suggests that regulatory interactions with the EMA may be at an earlier stage of development or have not yet been publicly disclosed.

The parallel regulatory successes with the FDA and NMPA for different indications highlight a robust and geographically diversified regulatory strategy by MediLink Therapeutics. This dual validation from major global agencies not only expedites development in these key regions but also enhances the overall credibility and perceived global value of YL-201. The focus on NMPA designations for indications like NPC, which has a high prevalence in China, also suggests a strategic commitment to addressing significant domestic health challenges, potentially leading to earlier market access in that region.

VII. Strategic Alliances and Collaborations

MediLink Therapeutics has proactively engaged in strategic alliances and collaborations to advance the development of YL-201 and leverage its proprietary TMALIN® ADC technology platform. These partnerships with major pharmaceutical companies provide access to additional resources, expertise, and complementary therapeutic agents, which can accelerate and broaden the scope of YL-201's clinical program.

Key collaborations include:

• Amgen: A global clinical trial collaboration and supply agreement was established to evaluate YL201 in combination with Amgen's IMDELLTRA™ (tarlatamab), a DLL3- and CD3-targeting BiTE® (Bispecific T-cell Engager) molecule. Amgen is leading a global Phase Ib study (NCT06898957) to assess this combination in patients with extensive-stage small cell lung cancer (ES-SCLC).[8] MediLink provides the investigational drug YL201 for this study.[8] This partnership is significant as it combines two innovative agents with distinct mechanisms of action for a highly aggressive cancer.
• AstraZeneca: MediLink has entered into a clinical collaboration with AstraZeneca to explore the therapeutic potential of YL201 combined with Imfinzi® (durvalumab), AstraZeneca's anti-PD-L1 immune checkpoint inhibitor. A multicenter, open-label, Phase I/Ib study is planned to evaluate the safety, efficacy, and pharmacokinetics of this combination in patients with various solid tumors.[5] Preclinical studies have indicated potential synergy between YL201 and durvalumab.[7]

These collaborations focusing on YL-201 combination therapies demonstrate a clear strategy to enhance its efficacy and broaden its applicability. Beyond YL-201, MediLink has also leveraged its TMALIN® platform through licensing agreements:

• Zai Lab: A strategic collaboration and worldwide license agreement allows Zai Lab to use MediLink's TMALIN® ADC platform to develop ZL-6201, a novel ADC targeting Leucine-rich repeat-containing protein 15 (LRRC15).[5] This collaboration validates the TMALIN® platform itself for creating new ADC candidates.
• BioNTech: MediLink and BioNTech initially collaborated on BNT326/YL202, a next-generation anti-HER3 ADC based on the TMALIN® platform. This partnership has since expanded into a multi-target TMALIN® ADC platform collaboration, allowing BioNTech to utilize the technology for developing ADC candidates against several targets.[17]

These alliances underscore the perceived value of both YL-201 as a therapeutic candidate and the TMALIN® platform as a versatile technology for ADC development. The partnerships with Zai Lab and BioNTech specifically highlight that MediLink's core technology is recognized as a valuable asset for generating novel ADCs, thereby extending MediLink's business model beyond its internal pipeline. This flexible partnering approach, which includes allowing partners like Amgen to lead global studies [8], enables MediLink to leverage the strengths of larger organizations, such as global clinical trial infrastructure and specific disease area expertise. Such a pragmatic strategy can de-risk aspects of development, accelerate timelines, and ultimately maximize the potential for its innovations to reach patients worldwide.

VIII. Discussion

YL-201 is emerging as a significant contender in the landscape of antibody-drug conjugates, particularly those targeting B7-H3. Its development trajectory, underpinned by the innovative TMALIN® platform, has yielded promising clinical data in challenging oncological settings.

A. YL-201's Position in the B7-H3 ADC Landscape

B7-H3 is an increasingly popular target for ADC development due to its widespread overexpression in various tumors and limited presence in normal tissues.2 Several other B7-H3-targeting ADCs are in clinical development, including 7MW3711, BNT324/DB-1311 (also known as DB-1311), and vobra duo (vobramitamab duocarmazine, MGC018).29

The Phase I/II data for YL-201, particularly the overall response rate (ORR) of approximately 68-70% in heavily pre-treated extensive-stage small cell lung cancer (ES-SCLC) and around 49-51% in recurrent/metastatic nasopharyngeal carcinoma (R/M NPC), alongside a median progression-free survival (mPFS) of 6.2 months in SCLC and 7.2 months in NPC, set a notable benchmark.1 For instance, vobra duo (MGC018) reported confirmed ORRs of 20% (2.0 mg/kg arm) and 41% (2.7 mg/kg arm) in metastatic castration-resistant prostate cancer (mCRPC) in the TAMARACK study, with a median rPFS of 8.5 and 7.5 months respectively, though direct cross-trial comparisons are challenging due to different patient populations and tumor types.31 Data for 7MW3711 and BNT324/DB-1311 are also emerging from early-phase studies.29

A key differentiating factor for YL-201 appears to be its TMALIN® platform, which is designed for enhanced stability, homogeneous high drug-to-antibody ratio (DAR), and a dual (extracellular and intracellular) cleavage mechanism for its topoisomerase I inhibitor payload.[4] This platform likely contributes to YL-201's manageable safety profile, especially the very low incidence of treatment-related interstitial lung disease (ILD) (around 1%).[1] ILD can be a dose-limiting and serious toxicity for some ADCs, and a favorable profile in this regard could provide YL-201 with a significant clinical advantage. While comprehensive comparative data is awaited, YL-201's early results position it favorably within this competitive field.

B. Potential to Address Unmet Medical Needs

The clinical development of YL-201 has strategically focused on indications with substantial unmet medical needs. Relapsed/refractory SCLC carries a dismal prognosis, with limited effective treatment options after failure of first-line platinum-based chemotherapy and immunotherapy.[19] The high ORR and meaningful mPFS demonstrated by YL-201 in this population offer the potential for a significant therapeutic advance.[1] Similarly, R/M NPC patients who have progressed after multiple lines of therapy, including PD-(L)1 inhibitors and chemotherapy, face a scarcity of effective treatments.[6] YL-201's activity in this setting could fill a critical void.[1] The reported efficacy in SCLC patients with brain metastases further addresses a challenging clinical scenario where many systemic agents have limited utility.[1]

C. Strengths and Limitations based on available data

YL-201 exhibits several strengths based on the current data:

• Strong Efficacy Signals: High ORRs and promising mPFS in difficult-to-treat, heavily pre-treated patient populations (SCLC, NPC), and pan-tumor activity in other solid tumors.[1]
• Activity in Brain Metastases: Demonstrated efficacy in SCLC patients with CNS involvement is a notable advantage.[1]
• Manageable Safety Profile: Predominantly hematological toxicities that are generally manageable, and a very low incidence of ILD (around 1%).[1]
• Innovative TMALIN® Platform: The proprietary linker-payload technology appears to confer favorable pharmacokinetic and safety properties, contributing to an enhanced therapeutic window.[4]
• Regulatory Validation: Orphan Drug Designation from the FDA and Breakthrough Therapy Designations from the NMPA underscore its potential clinical significance.[4]
• Robust Collaboration Pipeline: Partnerships with major pharmaceutical companies for combination studies validate its potential and provide resources for broader development.[7]

Limitations include:

• Maturing Data: While pivotal Phase III trials are ongoing, much of the currently available detailed efficacy and safety data comes from Phase I/II studies. Long-term overall survival (OS) data is still maturing for most cohorts.
• Pending Phase III Results: Confirmation of efficacy and safety in larger, randomized Phase III trials is essential for regulatory approval and establishment as a standard of care.
• Potential for Resistance: As with all targeted therapies, the potential for acquired resistance mechanisms to emerge over time is a consideration, although the TMALIN platform's design might mitigate some forms of ADC resistance.[11]
• Biomarker Development: While B7-H3 expression is the primary selection criterion, further refinement of biomarkers to predict response or optimize patient selection may be beneficial. Current Phase III trial protocols include assessment of B7-H3 expression correlation with efficacy.[9]

D. Future Research Directions

The ongoing development of YL-201 is well-defined, but several avenues for future research could maximize its therapeutic potential:

• Completion and Readout of Pivotal Trials: Successful completion of the Phase III trials in SCLC (NCT06612151) and NPC (NCT06629597) is the immediate priority to confirm its benefit.
• Expansion into Earlier Lines of Therapy: Based on strong efficacy in relapsed/refractory settings, exploring YL-201 in earlier lines of treatment for SCLC, NPC, and other responsive tumors, potentially in combination regimens (as already initiated with NCT06898957 Part 3 [24]), could significantly impact patient outcomes.
• Development in Other B7-H3 Expressing Tumors: Data from the Phase I/II basket trials should guide expansion into other solid tumor types where B7-H3 is prevalent and an unmet need exists (e.g., NSCLC, prostate cancer, esophageal cancer, as suggested by preclinical data [11]).
• Biomarker Refinement: While B7-H3 expression is a prerequisite, further investigation into quantitative levels of expression or other co-existing biomarkers could help identify patient populations most likely to benefit or those who might require combination approaches.
• Understanding and Overcoming Resistance: Research into potential mechanisms of resistance to YL-201 will be important for developing strategies to overcome it, possibly through rational combinations or next-generation constructs.
• Optimization of Combination Strategies: Continued exploration of YL-201 with various agents (immunotherapies, other targeted drugs, chemotherapy) across different tumor types will be key to unlocking its full potential as a versatile anti-cancer therapeutic.

The success of YL-201, if its promise is borne out in Phase III studies, would represent a significant clinical advancement. It would also serve as a powerful validation of B7-H3 as a broad ADC target and establish MediLink's TMALIN® platform as a leading technology in the competitive ADC arena, likely fostering further innovation and partnerships in the field. This aligns with MediLink's overarching objective to develop globally competitive conjugated drugs that address significant unmet medical needs.[7]

IX. Conclusion

YL-201, an investigational B7-H3-targeting antibody-drug conjugate developed by MediLink Therapeutics, stands out as a highly promising therapeutic candidate for various solid tumors. Its design, leveraging the sophisticated and proprietary TMALIN® technology platform, appears to confer a favorable balance of potent anti-tumor activity and a manageable safety profile. The dual cleavage mechanism of the TMALIN® linker, combined with high payload stability and homogeneity, likely contributes to the observed efficacy and tolerability.

Clinical data from Phase I/II studies have demonstrated compelling overall response rates and encouraging progression-free survival in heavily pre-treated patients with challenging malignancies, most notably extensive-stage small cell lung cancer and recurrent/metastatic nasopharyngeal carcinoma.[1] The activity observed in SCLC patients with brain metastases is particularly noteworthy.[1] The safety profile, characterized mainly by manageable hematological toxicities and a remarkably low incidence of severe non-hematological events like interstitial lung disease, further enhances its therapeutic potential.[1]

The advancement of YL-201 into pivotal Phase III trials for both SCLC and NPC, supported by significant regulatory recognitions such as FDA Orphan Drug Designation and NMPA Breakthrough Therapy Designations, underscores the confidence in its clinical value.[4] Furthermore, strategic collaborations with leading pharmaceutical companies to explore YL-201 in combination regimens highlight its potential as a versatile cornerstone therapy in future oncological treatment paradigms.[7]

Pending the outcomes of ongoing registrational studies, YL-201 has the potential to become a significant new treatment option for patients with limited therapeutic alternatives, addressing critical unmet medical needs. Its development journey exemplifies the successful translation of innovative ADC platform technology into tangible clinical benefits, positioning YL-201 as a potentially best-in-class agent targeting B7-H3 and a flagship asset for MediLink Therapeutics. The continued exploration and confirmation of its efficacy and safety will be pivotal in defining its ultimate role in cancer therapy.

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