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Innovent Biologics’ IBI363 Granted Breakthrough Therapy Designation for Melanoma
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China-based Innovent Biologics, Inc. (HKG: 1801) announced that it has received breakthrough therapy designation (BTD) from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for its investigational drug IBI363. The designation is for the treatment of unresectable locally advanced or metastatic mucosal or acral melanoma…
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Sanofi to Acquire DR-0201 for $600 Million to Advance Myeloid Cell Engager
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Sanofi (EPA: SAN, NASDAQ: SNY) announced plans to acquire DR-0201, a bispecific myeloid cell engager (MCE) targeting CD20, through the acquisition of its developer, Dren Bio, Inc. The deal underscores Sanofi’s commitment to expanding its portfolio in autoimmune diseases with a novel therapeutic approach. Deal StructureSanofi will pay an upfront…
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Pierre Fabre Partners with RedRidge Bio on BPA Drug Development for Oncology and Dermatology
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France-based Pierre Fabre Laboratories announced an exclusive R&D collaboration and license agreement with Switzerland-headquartered RedRidge Bio AG. The partnership focuses on discovering and developing biparatopic antibody (BPA) drug candidates against multiple targets, with therapeutic applications in precision oncology, dermatology, and rare diseases. Collaboration DetailsUnder the agreement, RedRidge Bio will be…
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Pfizer’s Elrexfio Receives Conditional NMPA Approval for Relapsed Multiple Myeloma
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US giant Pfizer (NYSE: PFE) announced receiving conditional approval from China’s National Medical Products Administration (NMPA) for its bispecific antibody (BsAb) Elrexfio (elranatamab). The drug is now approved to treat triple-class exposed (TCE) relapsed or refractory multiple myeloma (r/r MM). Mechanism of ActionElrexfio works by binding to CD3 on T…
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ImmuneOnco’s Timdarpacept (IMM01) and IMM2510 Receive NMPA Approval for Clinical Study in Advanced Malignant Tumors
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China-based ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (HKG: 1541) has received approval from the National Medical Products Administration (NMPA) to commence a clinical study for its novel therapeutic combination. The study will evaluate timdarpacept (IMM01), an SIRPαFc fusion protein, in combination with IMM2510, a PD-L1/VEGF bispecific antibody (BsAb), with or without chemotherapy,…
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CStone Pharmaceuticals Doses First Patient in CS2009 Phase I Study for Solid Tumors
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China-based CStone Pharmaceuticals (HKG: 2616) announced the first patient dosing in a global, multi-center Phase I study for its CS2009, a novel PD-1/VEGF/CTLA-4 trispecific antibody, in Australia. No infusion reactions or other adverse events were observed, marking a promising start to the clinical evaluation of the drug. Drug ProfileCS2009, an…
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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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Zhejiang Huahai Pharma’s HB0056 Receives NMPA Approval for Asthma Trials
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China-based Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521) announced that its bispecific antibody HB0056 has received clinical trial approval from China’s National Medical Products Administration (NMPA) for asthma. The approval follows similar clearances in New Zealand (October 2024) and the U.S. (January 2025), positioning the drug for global development. Clinical…
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Phanes Therapeutics Doses First Patient in Peluntamig Study for SCLC and NEC
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Sino-US biotech Phanes Therapeutics Inc. announced that the first patient has been dosed in a clinical study evaluating peluntamig (PT217) in combination with chemotherapy. The trial focuses on patients with small cell lung cancer (SCLC) and neuroendocrine carcinoma (NEC). Drug ProfilePeluntamig is a bispecific antibody (BsAb) targeting DLL3 and CD47.…
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Sunshine Guojian and Shenyang 3SBio License 612 and 708 Programs for Anti-Tumor Development
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China-based Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd and Shenyang 3SBio Co., Ltd, both subsidiaries of 3SBio Inc. (HKG:1530), have entered into a licensing agreement for Sunshine Guojian’s 612 and 708 programs. Under the agreement, Shenyang 3SBio will obtain exclusive rights to develop, file regulatory applications, modify, use, manufacture, and market…
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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…
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LINDIS Biotech’s Korjuny Approved by European Commission for Malignant Ascites
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Germany-based LINDIS Biotech GmbH announced that it has received market approval from the European Commission (EC) for its Korjuny (catumaxomab), making the trifunctional anti-CD3 x anti-EpCAM antibody (trAb) the only approved therapy for patients with malignant ascites (MA) across Europe. Drug BackgroundCatumaxomab was originally discovered by German firm Trion Pharma…
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J&J’s Rybrevant and Talvey Win Separate NMPA Approvals in China
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US pharma giant Johnson & Johnson (J&J, NYSE: JNJ) announced receiving marketing approvals from China’s National Medical Products Administration (NMPA) for two of its biologics: Rybrevant (amivantamab) for non-small cell lung cancer (NSCLC) and Talvey (talquetamab) for multiple myeloma. The approvals mark J&J’s latest expansion in China’s oncology market. Rybrevant…
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Akeso Completes Enrollment for Global Phase III Trial of Ivonescimab in Lung Cancer
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China-based biotech Akeso Inc. (HKG: 9926) announced the completion of patient enrollment in the global Phase III clinical trial (HARMONi-6/AK112-306) assessing its PD-1/VEGF bispecific antibody (BsAb) ivonescimab. The trial compares ivonescimab combined with platinum-based chemotherapy to PD-1 inhibitor tislelizumab in combination with platinum-based chemotherapy in first-line squamous non-small cell lung…
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Regeneron’s Q4 Financials Show 10% Revenue Growth, Driven by Eylea and Libtayo
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US-based biopharmaceutical company Regeneron (NASDAQ: REGN) released its Q4 2024 financial report, showing revenues up 10% year-on-year (YOY) to USD 3.79 billion. For the full year, sales grew by 8% to USD 14.2 billion. The results highlight the continued strength of Regeneron’s portfolio, particularly its top-selling products. Top Performers in…
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Chongqing Genrix’s Silevimig NDA Accepted for Rabies Immunization Review
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China-based Chongqing Genrix Bio Pharmaceutical Co., Ltd. (SHA: 688443) has announced that a New Drug Application (NDA) filing for its silevimig (GR1801) has been accepted for review by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). The drug is intended for passive immunization in adults…
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Simcere Zaiming and AbbVie Ink $1.055B License Deal for MM Drug SIM0500
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China-based Simcere Pharmaceutical Group Ltd (HKG: 2096) has announced a significant strategic move through its oncology subsidiary, Simcere Zaiming. The company has entered into a license option agreement with global pharmaceutical giant AbbVie Inc. (NYSE: ABBV) for the development of its promising drug candidate, SIM0500. Deal Structure and FinancialsUnder the…
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Ouro Medicines Launches with $120M Series A Financing for CM336 Development
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Ouro Medicines, the licensee of China-based Keymed Biosciences Inc.’s (HKG: 2162) CM336, has successfully launched with a USD 120 million Series A financing round. The California-headquartered biotech, founded by Monograph Capital in partnership with GSK plc (NYSE: GSK), saw the funding co-led by TPG Life Sciences Innovations, NEA, and Norwest…
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Doma Biopharma Receives FDA Clearance for DM002 Phase I Study-Fineline Info & Tech
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China-based Doma Biopharmaceutical (Suzhou) Co., Ltd has announced that it has received clearance from the US Food and Drug Administration (FDA) to initiate a Phase I clinical study. The study will assess the safety, tolerability, and preliminary anti-tumor activity of its Category 1 drug DM002 in multiple solid tumors. This…
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WuXi Biologics and Candid Therapeutics Ink Global Research Agreement for Trispecific T-cell Engager
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China-based Contract Research, Development and Manufacturing Organization (CRDMO) WuXi Biologics (HKG: 2269) has announced a research service cooperation agreement with US-headquartered Candid Therapeutics, Inc. This strategic partnership aims to accelerate the development of innovative T-cell engagers for autoimmune and inflammatory diseases. Terms of the AgreementUnder the terms of the agreement,…
