MHB036C: A Comprehensive Clinical and Scientific Profile of a Novel TROP2-Targeted Antibody-Drug Conjugate

1.0 Executive Summary

MHB036C is a novel, investigational antibody-drug conjugate (ADC) developed by Minghui Pharmaceutical as a potential therapy for advanced solid tumors. It is engineered to target Trophoblast cell-surface protein 2 (TROP2), a well-validated tumor-associated antigen overexpressed in a multitude of malignancies. The molecular architecture of MHB036C is derived from Minghui's proprietary SuperTopoi™ ADC platform, which combines three distinct components: a humanized anti-TROP2 monoclonal antibody, a highly potent proprietary DNA topoisomerase I (TopoI) inhibitor payload, and a stable, cleavable linker. Preclinical evidence established a strong foundation for clinical development, demonstrating antitumor potency 3 to 10 times greater than deruxtecan (DXd) counterparts and a favorable safety profile notable for the absence of severe pulmonary toxicities.

The clinical development program for MHB036C is comprehensive, encompassing Phase I/II dose-escalation and expansion studies across multiple jurisdictions. Early clinical data have demonstrated a manageable safety profile and compelling antitumor activity in heavily pre-treated patient populations. The most common treatment-related adverse events include stomatitis and myelosuppression, with Grade 3 stomatitis identified as the dose-limiting toxicity. Critically, no cases of interstitial lung disease (ILD) have been reported, a significant point of differentiation from other ADC platforms.

Efficacy signals are robust across several tumor types. In a broad population of 98 patients with advanced solid tumors, MHB036C achieved an objective response rate (ORR) of 33.7% and a disease control rate (DCR) of 83.7%. Particularly striking results were observed in specific cohorts, including an ORR of 33.3% in non-small cell lung cancer (NSCLC) and 60.0% in HER2-negative breast cancer. The most profound efficacy was seen in small cell lung cancer (SCLC), where the ORR reached 61.3% overall and as high as 80% in a specific dosing cohort, suggesting a potential breakthrough for this recalcitrant disease. These results position MHB036C as a potential best-in-class TROP2 ADC. Its future development trajectory includes ongoing dose optimization and a strategic Phase II combination study with MHB039A, Minghui's proprietary PD-1xVEGF bispecific antibody, aiming to establish a new standard of care in oncology.

2.0 Introduction: The Therapeutic Rationale for a Novel TROP2 ADC

The targeted delivery of cytotoxic agents to malignant cells represents a cornerstone of modern oncology drug development. Within this field, the selection of an appropriate cell surface antigen is paramount to achieving a wide therapeutic window. The development of MHB036C is predicated on the convergence of a high-value oncologic target, TROP2, and the precision of antibody-drug conjugate technology.

2.1 TROP2 as a High-Value Oncologic Target

Trophoblast cell-surface protein 2, also known as tumor-associated calcium signal transducer 2 (TACSTD2), is a transmembrane protein that has emerged as a compelling target for cancer therapy.[1] While its expression is limited in normal tissues, TROP2 is significantly overexpressed across a broad spectrum of epithelial cancers, including lung, breast, pancreatic, and urothelial carcinomas.[1] This differential expression pattern provides an attractive therapeutic target for selective cancer cell killing.

The biological role of TROP2 is intrinsically linked to oncogenesis. Its overexpression is associated with multiple hallmarks of cancer, including enhanced tumor aggressiveness, increased cellular proliferation, metastasis, and resistance to conventional therapies.[1] By participating in calcium signaling pathways, TROP2 influences cell adhesion, migration, and invasion, thereby promoting a more malignant phenotype and contributing to poor patient prognosis.[1] The widespread presence of TROP2 on tumor cells and its role in driving cancer progression firmly establish the rationale for developing TROP2-directed therapies.

2.2 The Antibody-Drug Conjugate (ADC) Paradigm

Antibody-drug conjugates are a sophisticated class of biopharmaceutical drugs designed to function as targeted chemotherapy. This therapeutic modality consists of three primary components: a monoclonal antibody that binds to a specific antigen on tumor cells, a highly potent cytotoxic agent (payload), and a chemical linker that attaches the payload to the antibody. The ADC paradigm leverages the specificity of the antibody to deliver the cytotoxic payload directly to cancer cells, minimizing systemic exposure and the associated off-target toxicities common with traditional chemotherapy. Upon binding to its target, the ADC is internalized by the cancer cell, where the linker is cleaved, releasing the payload to induce cell death. This targeted approach aims to maximize efficacy while improving the overall safety and tolerability of cancer treatment.

2.3 MHB036C: Identity and Development

MHB036C is an investigational new molecular entity developed by Minghui Pharmaceutical.[2] It is classified as an antineoplastic agent, specifically a TROP2-targeted immunoconjugate, and is currently in Phase I/II clinical development for the treatment of various advanced or metastatic solid tumors.[3] To ensure comprehensive identification across scientific literature and clinical trial registries, the compound is also known by several synonyms and code names, including MHB-036C, MHB 036C, ZG157, ZG-157, and Anti-TROP-2/TopoI ADC MHB036C.[1] Its development aims to address the unmet medical need in heavily pre-treated patient populations whose tumors express TROP2.

3.0 Molecular Architecture: The SuperTopoi™ ADC Platform

The distinct therapeutic profile of MHB036C is a direct result of its sophisticated molecular design, which originates from Minghui Pharmaceutical's proprietary SuperTopoi™ ADC platform.[2] This platform technology is not merely a construct for a single drug but represents a strategic, modular asset for the company, as evidenced by its concurrent use in the development of another ADC, MHB088C, which targets B7-H3.[6] The platform integrates three optimized components—a targeting antibody, a cytotoxic payload, and a linker—each engineered to contribute to a superior therapeutic index. The clinical performance of MHB036C, therefore, serves as a critical validation of the underlying platform technology, influencing the perceived value and risk profile of Minghui's broader ADC pipeline.

3.1 The Targeting Moiety: A Humanized Anti-TROP2 Monoclonal Antibody

The specificity of MHB036C is conferred by its antibody component, a humanized anti-TROP2 monoclonal antibody.[2] This antibody is engineered to bind with high affinity to the TROP2 tumor-associated antigen expressed on the surface of cancer cells.[1] A key design feature of this antibody is its optimization to "minimize potential toxicities mediated by non-specific uptake".[8] This engineering is intended to reduce the likelihood of the ADC being taken up by non-target cells, a common source of toxicity for this drug class. By enhancing its specificity for TROP2-expressing tumor cells, the antibody aims to improve the overall safety profile of the conjugate from its very first point of biological interaction.

3.2 The Cytotoxic Payload: A Novel, Highly Potent Topoisomerase I Inhibitor

The cell-killing capacity of MHB036C is derived from its cytotoxic payload, a proprietary DNA topoisomerase I (TopoI) inhibitor.[1] Topoisomerase I is a critical nuclear enzyme responsible for relaxing supercoiled DNA during replication and transcription. By inhibiting this enzyme, the payload induces single-strand DNA breaks, which, when encountered by the replication machinery, are converted into irreversible double-strand breaks. This extensive DNA damage leads to cell cycle arrest and ultimately triggers apoptosis, or programmed cell death.[1]

A central attribute of the SuperTopoi™ platform is the exceptional potency of its payload. Preclinical assessments have indicated that this novel TopoI inhibitor is approximately 5 to 10 times more potent than DXd, the exatecan-derivative payload utilized in the highly successful deruxtecan class of ADCs.[8] This heightened potency is a cornerstone of the claim for MHB036C's potential best-in-class status, as it may allow for effective tumor cell killing even in tumors with moderate or low levels of TROP2 expression, potentially broadening the eligible patient population.[6]

3.3 The Linker Technology: A Stable, Cleavable Linker

Connecting the antibody and the payload is a stable, cleavable linker.[2] The design of the linker is a critical determinant of an ADC's efficacy and safety. The linker in MHB036C is engineered for high stability in systemic circulation. This stability is crucial for preventing the premature release of the highly potent payload into the bloodstream, which could lead to severe off-target toxicities. Once the ADC has been internalized by the target tumor cell, the linker is designed to be efficiently cleaved by intracellular enzymes, ensuring the rapid and localized release of the TopoI inhibitor at its site of action.[1] This balance of systemic stability and intracellular lability is a hallmark of advanced ADC linker technology.

3.4 Integrated Mechanism of Action

The therapeutic effect of MHB036C is achieved through a coordinated, multi-step process that exemplifies the ADC paradigm:

1. Targeting and Binding: Following intravenous administration, MHB036C circulates throughout the body. The anti-TROP2 antibody component specifically seeks out and binds to TROP2 antigens on the surface of tumor cells.[1]
2. Internalization: Upon successful binding, the entire ADC-TROP2 antigen complex is drawn into the tumor cell via endocytosis.[1]
3. Payload Release: Within the intracellular environment of the tumor cell, the cleavable linker is degraded, liberating the highly potent TopoI inhibitor payload from the antibody.[1]
4. Cytotoxicity: The freed TopoI inhibitor translocates to the nucleus, where it inhibits DNA topoisomerase I activity. This action disrupts the process of DNA replication, leading to catastrophic DNA damage, cell cycle arrest, and subsequent apoptosis of the TROP2-expressing tumor cell.[1]

4.0 Preclinical Evidence Package: Foundation for Clinical Development

Prior to its introduction into human trials, MHB036C underwent extensive preclinical evaluation to establish its therapeutic potential and safety profile. The data generated from these in vitro and in vivo studies provided a compelling rationale for advancing the molecule into clinical development, highlighting both superior potency compared to existing technologies and a differentiated safety profile.

4.1 Superior Antitumor Potency

A key finding from the preclinical evidence package was the exceptional antitumor efficacy of MHB036C.[2] In head-to-head comparative studies using various cancer models, MHB036C was demonstrated to be 3 to 10 times more potent at killing tumor cells than analogous ADCs constructed with a DXd payload, such as a DS-1062a analog.[2] This superior potency is attributed directly to the novel TopoI inhibitor developed for the SuperTopoi™ platform.

Furthermore, this enhanced efficacy was observed to be particularly robust against cancer cells with moderate or even low levels of TROP2 antigen expression.[6] This finding is of significant clinical importance. Many ADCs require high antigen density on the tumor cell surface for optimal activity, which can limit their applicability. The ability of MHB036C to effectively kill cells with lower target expression suggests it may have a broader therapeutic window and could be effective in a larger, more heterogeneous patient population, including those who might not respond to other TROP2-targeted agents.

4.2 Favorable and Differentiated Preclinical Safety Profile

Alongside its potent efficacy, MHB036C demonstrated an "excellent safety profile" in preclinical Good Laboratory Practice (GLP) toxicology studies.[2] These formal safety assessments revealed no unique or unexpected toxicities compared to other agents in its class.[2]

A pivotal and differentiating observation from these studies was the absence of severe pulmonary toxicities.[2] Interstitial lung disease (ILD) and pneumonitis are known, serious risks associated with some other ADC platforms, particularly those utilizing deruxtecan-based payloads, and often lead to black box warnings on approved products. The clean preclinical signal regarding pulmonary safety for MHB036C was a critical differentiator that suggested the SuperTopoi™ platform might possess an inherently better safety profile. This finding established a key hypothesis to be tested and a major point of focus for safety monitoring throughout the clinical development program.

5.0 Clinical Development Program: A Multi-Pronged Strategy

The clinical development of MHB036C is characterized by a comprehensive and ambitious strategy designed to efficiently evaluate its safety and efficacy across a range of solid tumors and in multiple therapeutic settings. The program includes foundational first-in-human studies, indication-specific expansion cohorts, and a forward-looking combination therapy trial, reflecting a clear vision for the drug's potential role in oncology.

5.1 First-in-Human and Dose-Finding Studies

The initial phase of clinical investigation for MHB036C involved parallel first-in-human (FIH) trials to establish its safety, tolerability, and pharmacokinetic (PK) profile, and to determine the appropriate dose for further studies.

• NCT05642949: This Phase I/II trial, initiated in Australia, was the first study to administer MHB036C to human subjects. The study is designed with two parts: a dose-escalation phase using an accelerated titration followed by a traditional 3+3 design to identify the Maximum Tolerated Dose (MTD), and a subsequent dose-expansion phase. The expansion phase aims to further evaluate safety and gather preliminary efficacy data in predefined cohorts of patients with advanced or metastatic solid tumors to determine the Recommended Phase 2 Dose (RP2D).[3]
• NCT06373406 / CTR20231246: A parallel Phase I/II study with a similar design was initiated in China to evaluate MHB036C in patients with advanced solid tumors. This large study, with an estimated enrollment of 200 participants, also includes dose-escalation and dose-expansion segments with the primary objectives of determining MTD and RP2D while assessing safety, PK, immunogenicity, and preliminary antitumor activity.[12]

5.2 Indication-Specific Development

Following the initial dose-finding phase, the clinical program has advanced into indication-specific cohorts to explore the efficacy of MHB036C in tumor types where TROP2 is highly expressed and there is a significant unmet medical need. The highest phase of development reached is Phase II for Non-Small Cell Lung Cancer (NSCLC), a major area of focus.[3] The drug is also being investigated in Phase II for Pancreatic Ductal Adenocarcinoma.[16] The dose-expansion cohorts of the foundational Phase I/II studies are actively recruiting patients with a range of malignancies, including but not limited to NSCLC, small cell lung cancer (SCLC), pancreatic cancer, head and neck squamous cell carcinoma (HNSCC), and urothelial carcinoma (UC).[11]

5.3 Strategic Combination Therapy Trial

A key element of Minghui Pharmaceutical's long-term strategy for MHB036C is its evaluation in combination with other anticancer agents. This approach is embodied in a dedicated Phase II trial.

• NCT07130383: This is an open-label, multicenter Phase II study designed to evaluate MHB036C in combination with MHB039A.[17] MHB039A is Minghui's proprietary investigational bispecific antibody that simultaneously targets both PD-1 and VEGF, two critical pathways in tumor growth and immune evasion.[18] The trial is designed with a safety run-in phase followed by an indication expansion phase, initially targeting patients with advanced breast cancer and other advanced solid tumors.[17]

The decision to pair MHB036C with an in-house immuno-oncology asset, rather than a more established, externally owned PD-1 inhibitor, is a significant strategic choice. It reflects a high-risk, high-reward approach aimed at creating a proprietary, high-value combination regimen that Minghui can fully control. This strategy suggests a strong belief that the dual blockade of PD-1 and VEGF by MHB039A will create a synergistic antitumor effect when combined with the TROP2-targeted cytotoxicity of MHB036C. If successful, this approach could allow the company to capture the entire value of a novel standard-of-care regimen, potentially leapfrogging competitors who rely on partnerships for combination therapies. This ambitious plan underscores a long-term vision for market leadership and significant confidence in the potential of both investigational assets.

6.0 Clinical Efficacy in Advanced Solid Tumors

Preliminary data from the ongoing clinical trials of MHB036C have demonstrated compelling and clinically meaningful antitumor activity across a variety of heavily pre-treated solid tumors. The results, particularly those presented from the Phase 1/2 study at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, have provided strong validation for the drug's potent preclinical profile and have identified specific tumor types where it may offer a significant therapeutic advantage.[8]

6.1 Overall Activity in a Broad Patient Population

In a pooled analysis of 98 efficacy-evaluable patients with different types of advanced or metastatic solid tumors, who were treated with MHB036C at doses ranging from 0.8 mg/kg to 4.0 mg/kg, the drug showed broad activity. The overall Objective Response Rate (ORR) across this heterogeneous population was 33.7% (33 out of 98 patients), and the Disease Control Rate (DCR), which includes patients with stable disease, was 83.7% (82 out of 98 patients).[2] A majority of these patients remained on treatment at the time of data cutoff, suggesting that the responses were not only frequent but also durable.[2]

6.2 Promising Efficacy in Non-Small Cell Lung Cancer (NSCLC)

In a cohort of 12 patients with advanced or metastatic NSCLC who had progressed on prior standard-of-care therapies, including platinum-based chemotherapy and immune checkpoint inhibitors (ICIs), MHB036C demonstrated significant activity. In this difficult-to-treat population, treatment with MHB036C at doses between 1.3 mg/kg and 2.25 mg/kg resulted in an ORR of 33.3% (4 out of 12 patients) and a DCR of 83.3%.[8] These results are highly encouraging, as they indicate that MHB036C can induce responses in patients who have exhausted conventional treatment options.

6.3 Strong Efficacy Signal in HER2-Negative Breast Cancer

MHB036C has also shown a strong signal of efficacy in HER2-negative breast cancer, a setting with a high unmet need. In a small subset of 5 patients, which included 4 individuals with triple-negative breast cancer (TNBC) and one with hormone receptor-positive (HR+)/HER2- breast cancer, the ORR was 60.0% (3 out of 5 patients).[8] While this cohort is small, such a high response rate in this patient population, particularly in TNBC, is noteworthy and warrants further investigation in larger expansion cohorts.

6.4 Exceptional Efficacy Signal in Small Cell Lung Cancer (SCLC)

The most striking efficacy results to date have been observed in patients with advanced SCLC, a notoriously aggressive and challenging malignancy with limited treatment options in later lines. In a cohort of 31 efficacy-evaluable patients, MHB036C achieved an ORR of 61.3% (19 out of 31 patients) and a DCR of 93.5% (29 out of 31 patients).[2]

The responses in SCLC patients appear to be both deep and durable. At the time of analysis, 77.4% of these patients remained on treatment. Furthermore, two patients achieved a complete response (CR) of their target lesions at the 3.0 mg/kg dose level.[2] An analysis of a specific dosing cohort of 10 patients receiving 1.6 mg/kg every two weeks (Q2W) revealed an even higher ORR of 80% and a DCR of 90%.[2] This level of activity is exceptional for relapsed/refractory SCLC and strongly suggests that this indication may represent the most promising and direct path to registration for MHB036C.

The following table summarizes the key efficacy findings from the clinical program to date.

Tumor Type	Patient Population	N	Objective Response Rate (ORR)	Disease Control Rate (DCR)	Source Snippet(s)
All Solid Tumors	Advanced/Metastatic	98	33.7%	83.7%	2
NSCLC	Heavily Pre-treated	12	33.3%	83.3%	8
HER2-Neg Breast Cancer	Advanced/Metastatic	5	60.0%	N/A	8
SCLC	Advanced/Metastatic	31	61.3%	93.5%	2
SCLC (1.6 mg/kg Q2W)	Advanced/Metastatic	10	80.0%	90.0%	2

7.0 Clinical Safety, Tolerability, and Dosing Profile

A comprehensive understanding of the safety and tolerability profile of an investigational agent is as critical as its efficacy. The clinical data for MHB036C have established a safety profile that is manageable and, in some key aspects, differentiated from other ADCs in its class. The nature of the observed toxicities appears to be largely predictable and related to the drug's mechanism of action, rather than idiosyncratic or off-target events.

7.1 Dose Determination and Limiting Toxicities

The first-in-human Phase 1 study evaluated MHB036C administered intravenously every 3 weeks at doses ranging from 0.25 mg/kg to 2.25 mg/kg.[8] During the dose-escalation phase, two patients experienced dose-limiting toxicities (DLTs) at the highest dose level of 2.25 mg/kg. Both DLTs were Grade 3 stomatitis (severe inflammation of the mouth and lips).[8] Stomatitis is a known class effect of topoisomerase I inhibitors, indicating that this toxicity is directly related to the cytotoxic payload of MHB036C. Based on these findings, the Maximum Tolerated Dose (MTD) for the every-3-week schedule was determined to be 1.5 mg/kg.[8] Dose optimization and expansion studies are ongoing to establish the final Recommended Phase 2 Dose (RP2D), which may include alternative schedules such as the every-2-week regimen that showed high efficacy in SCLC.[2]

7.2 Profile of Treatment-Related Adverse Events (TRAEs)

Based on safety data from the initial 26 patients enrolled in the FIH study, the overall toxicity profile of MHB036C is consistent with its mechanism of action. The most common treatment-related adverse events (TRAEs), occurring in 25% or more of patients, were stomatitis, anemia, decreased appetite, vomiting, decreased white blood cell (WBC) count, fatigue, nausea, and decreased neutrophil count.[8]

When assessing more severe toxicities, the most common Grade $\geq 3$ TRAEs (occurring in 5% or more of patients) were stomatitis (34.6%), decreased WBC count (11.5%), decreased neutrophil count (7.7%), and anemia (7.7%).[8] The prominence of stomatitis and myelosuppression (decreased blood cell counts) is characteristic of TopoI inhibitors and suggests that the adverse events are primarily on-target effects of the payload.

7.3 A Differentiated Safety Profile: The Absence of Interstitial Lung Disease (ILD)

A critical and consistently reported finding across all clinical updates for MHB036C is the complete absence of any cases of interstitial lung disease (ILD) or pneumonitis.[2] This clinical observation validates the favorable preclinical safety data and represents a major potential point of differentiation for MHB036C. ILD is a serious, unpredictable, and potentially fatal pulmonary toxicity associated with other ADC platforms, most notably those utilizing deruxtecan-based payloads.

The safety profile of MHB036C is therefore distinguished not just by the frequency or severity of its adverse events, but by their nature. The primary toxicities, such as stomatitis, are predictable, mechanism-based, and can be proactively monitored and managed with established supportive care measures. In contrast, an idiosyncratic toxicity like ILD is far more challenging for clinicians to predict or manage and can severely restrict a drug's clinical utility. The favorable pulmonary safety profile of the SuperTopoi™ platform to date suggests a potentially superior safety profile that could be a decisive factor in its future clinical adoption and competitive positioning.

8.0 Strategic Analysis and Future Outlook

The collective preclinical and clinical data for MHB036C paint a picture of a highly promising therapeutic agent with the potential to make a significant impact on the treatment of multiple solid tumors. Its strategic development, potent efficacy, and differentiated safety profile position it as a formidable contender in the competitive landscape of TROP2-targeted therapies.

8.1 Competitive Landscape and "Best-in-Class" Potential

MHB036C is being developed with the stated goal of becoming a "best-in-class" TROP2 ADC.[8] This ambition is supported by several key differentiating factors when compared to established and other investigational agents in the same class, such as sacituzumab govitecan and datopotamab deruxtecan.

1. Potency and Efficacy: The preclinical data suggesting 5-10 times greater potency than DXd-based payloads is now being substantiated by remarkable clinical efficacy.[8] The ORR of over 60% observed in SCLC, a notoriously difficult-to-treat cancer, is particularly compelling and may exceed the efficacy benchmarks set by competitors in this indication.[2]
2. Differentiated Safety Profile: The absence of any reported cases of ILD is arguably the most significant competitive advantage for MHB036C.[2] As ILD remains a major clinical concern for other ADCs, a clean pulmonary safety profile could make MHB036C the preferred TROP2 ADC for many clinicians and patients, assuming its efficacy is confirmed in pivotal trials.
3. Potential for Broad Applicability: The preclinical finding that MHB036C is effective against tumors with low or moderate TROP2 expression could translate into a broader clinical utility.[6] If validated, this would allow MHB036C to be used in patient populations that might not be eligible for or respond to other TROP2 ADCs that require high antigen density.

8.2 Lead Indications and Path to Market

Based on the strength of the currently available data, small cell lung cancer (SCLC) has emerged as the clear lead indication for MHB036C. The exceptionally high response rates in a relapsed/refractory setting address a profound unmet medical need and could provide a basis for an accelerated regulatory approval pathway.[2] The ongoing Phase II development in NSCLC and HER2-negative/TNBC also represents substantial market opportunities, and positive data from these larger cohorts will be crucial for establishing its role in these more prevalent cancers.[3]

8.3 The Future is Combination

Minghui Pharmaceutical's long-term vision extends beyond monotherapy. The strategic decision to initiate a Phase II trial combining MHB036C with its proprietary PD-1xVEGF bispecific antibody, MHB039A, is a forward-thinking move.[18] The rationale for combining a potent cytotoxic agent with a dual-acting immuno-oncology agent is strong, with the potential for synergistic activity. Success in this trial could establish a novel, fully proprietary standard of care in NSCLC, breast cancer, or other solid tumors, thereby creating a durable competitive advantage and significantly amplifying the commercial potential of both assets.

8.4 Concluding Assessment

In conclusion, MHB036C is a novel TROP2-targeted antibody-drug conjugate with a highly compelling and differentiated clinical profile. It is built on an innovative platform technology that delivers a uniquely potent TopoI inhibitor payload, resulting in profound antitumor activity in heavily pre-treated solid tumors. The exceptional efficacy observed in small cell lung cancer, coupled with a manageable and predictable safety profile highlighted by the conspicuous absence of interstitial lung disease, strongly supports its potential to become a best-in-class agent. The well-designed and ambitious clinical development program is positioned to confirm these powerful early signals and to establish MHB036C as a major new therapeutic option in the armamentarium against advanced cancers.

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