Innovative, research-based, commercial-stage biopharmaceutical company operating in China and the United States, focusing on oncology, immunology, neuroscience and infectious disease; founded by Dr. Samantha Du. Incorporated in the Cayman Islands, dual-listed on NASDAQ (ZLAB) and the Hong Kong Stock Exchange (9688).
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- The global DLL3 targeted therapies market is projected to exceed USD 2 billion by 2030, driven by advancing pipeline candidates and additional products approaching regulatory review. - Amgen holds a leading commercial position through Imdelltra, which reported revenue of more than USD 600 million in 2025, validating the commercial potential of DLL3-directed oncology treatment. - Combination therapy has emerged as a significant research focus, with Zai Lab and Amgen evaluating zocilurtatug pelitecan alongside Imdelltra, and Zai Lab partnering with Boehringer Ingelheim to study it with obrixtamig. - The United States is expected to remain the leading sales market, while China is anticipated to maintain a prominent position in DLL3 clinical research.
- Coultreon Biopharma has appointed Prista Charuworn, MD, as Chief Medical Officer to accelerate clinical development of its first-in-class SIK3 inhibitor COL-5671. - Dr. Charuworn brings extensive immunology drug development experience from Gilead, AstraZeneca, Amgen, and Zai Lab, including treatments for inflammatory bowel disease and dermatologic indications. - COL-5671 demonstrated a favorable safety profile and promising pharmacokinetic and pharmacodynamic properties in a recently completed first-in-human study. - The company is preparing for clinical studies in ulcerative colitis and psoriasis and plans to progress COL-5671 into Phase II development.
- China's NMPA has approved TIVDAK (tisotumab vedotin) as the first antibody-drug conjugate for previously treated recurrent or metastatic cervical cancer in China. - The approval is supported by the global Phase 3 innovaTV 301 trial, which showed a statistically significant overall survival benefit (HR=0.70, p=0.0038) versus chemotherapy. - The China subpopulation demonstrated a 45% reduction in the risk of death (HR: 0.55), with consistent benefit regardless of prior anti-PD(L)1 therapy exposure. - Approximately 150,000 new cervical cancer cases are diagnosed annually in China, where treatment options remain limited after chemotherapy failure.
- Zoci achieved a 62.5% confirmed intracranial overall response rate at 1.6 mg/kg in extensive-stage small cell lung cancer, including four complete responses, with Grade ≥3 treatment-related adverse events at approximately 16%. - Global collaborations with Amgen and Boehringer Ingelheim are underway to evaluate Zoci combinations with T-cell engagers in small cell lung cancer and neuroendocrine carcinomas. - Zai Lab plans to submit its first global BLA to the FDA in late 2027, with the registrational Phase III DLLEVATE study on track to complete enrollment in the first half of 2027. - First-quarter 2026 total product revenue declined 6% year-over-year to $99.6 million, with a return to overall growth not expected until 2027.
- NICE has reversed its initial rejection and now recommends Genmab's Tivdak (tisotumab vedotin) for NHS use in recurrent or metastatic cervical cancer patients. - The approval follows improvements to Genmab's economic model incorporating real-world evidence from five-year patient follow-up data and updated cost comparisons. - Tivdak demonstrated a 30% reduction in death risk with median overall survival of 11.5 months versus 9.5 months for chemotherapy in the innovaTV 301 trial. - The Cancer Drugs Fund will provide initial coverage for approximately 117 eligible patients in England before routine NHS commissioning begins.
- Enterome has appointed Dr. Mehrdad Mobasher, former Chief Medical Officer at BeiGene and current IFLI Executive Partner, to its Board of Directors to strengthen leadership in developing OncoMimics immunotherapies. - The company's lead candidate EO2463 has shown positive Phase 2 interim data in low tumor-burden follicular lymphoma and received FDA Fast Track designation for the watch and wait setting. - IFLI, a key investor that contributed up to $9 million in Enterome's $19 million funding round, continues to support the development of OncoMimics therapies targeting B-cell lymphomas. - Enterome's OncoMimics platform represents a novel immunotherapy approach that induces rapid expansion of memory T-cells, with three candidates showing positive early Phase 2 data across blood cancers and solid tumors.
- China's National Medical Products Administration has approved COBENFY (xanomeline and trospium chloride) for treating schizophrenia in adults, marking the first major therapeutic advance in decades. - The drug represents a breakthrough with its novel mechanism targeting M1 and M4 muscarinic receptors, offering a fundamentally different approach from traditional dopamine-blocking antipsychotics. - COBENFY has already been included in China's national schizophrenia treatment guidelines and addresses the needs of approximately 8 million Chinese adults living with the condition. - Clinical studies demonstrate comprehensive improvement across positive, negative, and cognitive symptoms while avoiding common side effects like weight gain and movement disorders.
- Zai Lab announced the successful renewal of VYVGART, NUZYRA, and ZEJULA in China's 2025 National Reimbursement Drug List, ensuring continued patient access to these innovative therapies. - The company now has six products included on the NRDL, significantly reducing disease burden by enabling broad patient access to high-quality medicines for serious conditions. - VYVGART treats generalized myasthenia gravis affecting approximately 170,000 Chinese patients, while NUZYRA addresses bacterial infections with 10 million CABP cases annually. - ZEJULA provides maintenance therapy for ovarian cancer patients, addressing a critical need given over 55,000 new cases and 37,000 deaths annually in China.
- Zai Lab announced that updated Phase 1 trial data for zocilurtatug pelitecan, a potential first-in-class DLL3-targeted antibody-drug conjugate, will be presented at the AACR-NCI-EORTC International Conference in October 2025. - The ongoing global Phase 1 study is evaluating the safety and antitumor activity of zocilurtatug pelitecan in patients with extensive-stage small cell lung cancer who have progressed after at least one prior platinum-based chemotherapy regimen. - The company plans to initiate a Phase 3 registrational study in previously treated SCLC by year-end, highlighting the accelerated development timeline for this novel therapeutic approach. - Zocilurtatug pelitecan received FDA Orphan Drug Designation in January 2025, recognizing its potential to address the critical unmet need in treating one of the most aggressive solid tumors.
- Zocilurtatug pelitecan demonstrated a 68% overall response rate at 1.6 mg/kg dose in second-line extensive-stage small cell lung cancer patients. - The DLL3-targeted antibody-drug conjugate showed meaningful activity in brain metastases with an 80% response rate in untreated cases. - Zai Lab initiated a global registrational study in second-line+ ES-SCLC based on the promising Phase 1 data presented in October 2025. - The company reported 14% year-over-year revenue growth to $116.1 million in Q3 2025 while advancing multiple pipeline programs.
