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Zai Lab Submits TIVDAK BLA to China’s NMPA for Cervical Cancer Treatment
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Zai Lab Limited (NASDAQ: ZLAB, HKG: 9688) announced that a Biological License Application (BLA) for TIVDAK (tisotumab vedotin-tftv), an antibody-drug conjugate (ADC) originated by Seagen Inc., has been accepted for review by China’s National Medical Products Administration (NMPA). This marks a significant step forward in making this innovative therapy available…
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WuXi XDC and AbTis Partner to Advance Antibody-Drug Conjugate Innovation
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WuXi XDC (HKG: 2268), a joint venture between Wuxi Biologics (HKG: 2269) and WuXi STA (a subsidiary of WuXi AppTec Co., Ltd (SHA: 603259)), has entered into a memorandum of understanding (MOU) with South Korea-based biotech company AbTis. This collaboration aims to enhance innovation in antibody-drug conjugate (ADC) therapeutics and…
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Sichuan Kelun-Biotech’s Sacituzumab Tirumotecan Wins New NMPA Approval for NSCLC
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China-based Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (HKG: 6990) announced receiving another indication approval from the National Medical Products Administration (NMPA) for its sacituzumab tirumotecan (SKB264/MK-2870). The approval allows the use of this TROP2-targeted antibody drug conjugate (ADC) in adult patients with EGFR mutation-positive locally advanced or metastatic non-squamous non-small cell…
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Huadong Medicine Seeks Regular Approval for Elahere in Ovarian Cancer Treatment
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China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that its application for converting conditional to regular approval for Elahere (mirvetuximab soravtansine) has been accepted by the National Medical Products Administration (NMPA). This antibody drug conjugate (ADC) targets folate receptor α (FRα) and represents a significant step forward in the treatment…
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Sichuan Biokin Pharmaceutical Plans RMB3.9 Billion Private Placement for Novel Drug R&D
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China-based Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506) announced plans to raise up to RMB3.9 billion (USD537 million) through a private placement. The funds will be allocated to various novel drug research and development programs, furthering the company’s commitment to innovation in the biopharmaceutical sector. Funding AllocationThe proceeds from the…
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Jiangsu Hengrui Pharmaceuticals Receives NMPA Approval for SHR-4602 Clinical Study in Advanced Solid Tumors
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced receiving approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its SHR-4602 in combination with SHR-A2102, with or without adebrelimab (SHR-1316), in advanced solid tumors. This marks a significant step forward in the development of innovative…
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BioRay Biopharmaceutical’s BR111 Receives NMPA Clearance for Clinical Trials in ROR1-Positive Malignancies
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Zhejiang-based BioRay Biopharmaceutical has announced receiving clearance from the National Medical Products Administration (NMPA) to initiate clinical trials for its Category 1 biologic product, BR111. The drug, an antibody-drug conjugate (ADC) targeting dual epitopes of ROR1, is being developed to treat ROR1-positive hematological malignancies and solid tumors, marking a significant…
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CStone Pharmaceuticals’ CS5001 Enters Phase Ib Trial for Diffuse Large B-Cell Lymphoma
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China-based CStone Pharmaceuticals (HKG: 2616) has announced a Phase Ib clinical filing in Australia for its ROR1-targeted antibody-drug conjugate (ADC), CS5001, in combination with first-line standard-of-care (SoC) for diffuse large B-cell lymphoma (DLBCL). The move underscores the company’s commitment to expanding the therapeutic potential of CS5001 across hematologic and solid…
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AstraZeneca and Daiichi Sankyo’s Enhertu Shows Positive Results in Phase III Study
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Partners AstraZeneca (NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568) announced positive topline results from the Phase III DESTINY-Gastric04 study for Enhertu (trastuzumab deruxtecan). The HER2-targeted antibody drug conjugate (ADC) has demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of overall survival (OS) in patients with second-line…
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Duality Biotherapeutics Updates IPO Filing with HKSE under Chapter 18A Rules
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China-based Duality Biotherapeutics, Inc. updated its initial public offering (IPO) filing to the Hong Kong Stock Exchange (HKSE) late last week, taking advantage of the Chapter 18A rules to list as a pre-profit biotech company. Morgan Stanley, Jefferies Financial, and CITIC Securities act as its co-sponsors. Company Overview and PipelineSince…
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Hengrui Pharmaceuticals Gets NMPA Green Light for SHR-A2009 Study
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced that the National Medical Products Administration (NMPA) has approved the initiation of a Phase Ib/II clinical study for its drug candidate SHR-A2009. The study will assess the safety, tolerability, and efficacy of SHR-A2009 as a treatment for advanced solid tumors in…
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Akeso Inc. Completes Patient Enrollment for AK138D1 Phase I Study
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China-based biotech Akeso Inc. (HKG: 9926) announced the completion of patient enrollment in the Phase I clinical study assessing the safety, tolerability, pharmacokinetics, and preliminary efficacy of its AK138D1 in advanced malignant tumors in Australia. Drug ProfileAK138D1, an antibody-drug conjugate (ADC) targeting human epidermal growth factor receptor 3 (HER3), features…
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Huadong Medicine’s ADC HDM2005 Granted FDA Orphan Drug Designation for MCL
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China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that its antibody-drug conjugate (ADC) HDM2005 has been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) for the treatment of mantle cell lymphoma (MCL). Drug Mechanism and Preclinical ResultsPreclinical studies have shown that after HDM2005 enters the…
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WuXi XDC Expands MOU with LigaChem to Advance Next-Gen ADC Development
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WuXi XDC (HKG: 2268), a joint venture between Wuxi Biologics (HKG: 2269) and WuXi STA, a subsidiary of WuXi AppTec Co., Ltd (HKG: 2359, SHA: 603259), has signed an expanded Memorandum of Understanding (MOU) with South Korea’s LigaChem Biosciences, Inc. to accelerate the development of next-generation antibody drug conjugates (ADCs).…
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Summit Therapeutics and Pfizer Collaborate on Ivonescimab-ADC Combo for Solid Tumors
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Summit Therapeutics Inc. (NASDAQ: SMMT), the U.S. partner of China-based Akeso Inc. (HKG: 9926) for ivonescimab, announced a clinical collaboration with Pfizer (NYSE: PFE) to evaluate the combination of ivonescimab, Akeso’s PD-1/VEGF bispecific antibody (BsAb), with Pfizer’s antibody drug conjugates (ADCs) in multiple solid tumors. Collaboration DetailsUnder the agreement, Summit…
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Coherent Biopharma’s CBP-1019 Granted FDA Fast Track Status for Endometrial Cancer
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Coherent Biopharma Ltd, a Suzhou-based specialist in bispecific-ligand drug conjugates (Bi-XDC), announced that the U.S. Food and Drug Administration (FDA) has granted fast track designation to its lead candidate, CBP-1019, for the treatment of recurrent endometrial cancer in patients who have received prior platinum-based chemotherapy. FDA Designation and Drug ProfileThe…
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Hanx Biopharmaceuticals’ HX009 Receives NMPA Clearance for TNBC Study
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Hanx Biopharmaceuticals (Wuhan) Co., Ltd. announced that it has received clearance from the National Medical Products Administration (NMPA) for its HX009, a bifunctional macromolecule targeting PD-1 and CD47. The company plans to test the investigational cancer immunotherapy in combination with an antibody drug conjugate (ADC) for triple-negative breast cancer (TNBC)…
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Biokin Pharmaceutical’s BL-M07D1 Receives NMPA Approval for Phase II/III Study in HER2+ Breast Cancer
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China-based Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506) announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase II/III clinical study of its antibody drug conjugate (ADC), BL-M07D1, for the treatment of HER2 positive breast cancer. The trial will evaluate BL-M07D1 in combination…
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Biokin Pharmaceutical Registers Phase III Study for BL-B01D1 in EGFR Mutant NSCLC
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506) has registered a Phase III study on chinadrugtrials.org.cn to evaluate the efficacy of BL-B01D1 combined with osimertinib versus osimertinib alone as a first-line therapy for EGFR mutant locally advanced or metastatic non-small cell lung cancer (NSCLC). The study, led by Professor Zhou Caicun…
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3SBio and Sichuan Biokin Partner to Advance Solid Tumor Treatment in China
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China-based 3SBio Inc. (HKG: 1530) has announced a strategic partnership with fellow domestic firm Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506). The collaboration aims to advance the exploration of combining 3SBio’s 707 and Sichuan Biokin’s BL-B01D1 for the treatment of solid tumors in mainland China. Drug Profiles Collaboration DetailsThe partnership…
