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Hansoh Pharmaceutical’s Ameile Accepted for UK Regulatory Review
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China-based Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) announced that a Marketing Authorization Application (MAA) for its epidermal growth factor receptor (EGFR) inhibitor Ameile (almonertinib) has been accepted for review by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). The application seeks approval for Ameile as a first-line treatment…
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MegaRobo Secures USD 300 Million in Series C Round Led by Goldman Sachs
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Beijing-based MegaRobo Technologies, a company applying robotics and artificial intelligence (AI) in the life sciences field, has reportedly secured USD 300 million in a Series C financing round. The funding was led by Goldman Sachs, GGV Capital, and Asia Investment Capital, with participation from Sinovation Ventures, Pavilion Capital, Starr Capital,…
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Quoin Pharmaceuticals Partners with WinHealth for Rare Disease Treatments in Greater China
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US-based rare disease specialist Quoin Pharmaceuticals Ltd (NASDAQ: QNRX) announced a licensing and distribution agreement with Hong Kong WinHealth Pharma Group Ltd. The deal grants WinHealth rights to Quoin’s pipeline candidates QRX003 and QRX004 for Netherton syndrome and epidermolysis bullosa (EB) in the Greater China territory, including Hong Kong, Macau,…
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Alphamab Oncology Doses First Patient in Phase I Trial for PD-L1/OX40 Bispecific Antibody KN052
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China-based Alphamab Oncology (HKG: 9966) has announced the dosing of the first patient in a Phase I clinical trial in China (KN052-CHN-001) for its pipeline candidate KN052. This bispecific antibody (BsAb) targets programmed-death ligand 1 (PD-L1) and OX40 and is being evaluated as a treatment for general advanced solid tumors.…
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Walvax Biotechnology Halts EV71 Vaccine Development Amid Changing Disease Trends
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China’s Walvax Biotechnology Co., Ltd (SHE: 300142) has announced the decision to terminate a clinical study and end development for its recombinant enterovirus 71 (EV71) virus vaccine (Pichia pastoris). The company’s press release states that the recombinant EV71 vaccine, which first entered clinical trials in China in June 2019, was…
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Jiangsu Hengrui Medicine’s Hetrombopag Olamine Receives FDA Orphan Drug Designation for ITP
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China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced that it has received orphan drug designation (ODD) status from the US FDA for its hetrombopag olamine as a treatment for primary immune thrombocytopenia (ITP). The drug was approved in China in June 2021 for the treatment of ITP in…
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WuXi AppTec Faces Shareholder Divestment of Up to 3% Stake
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China-based Contract Research Organization (CRO) WuXi AppTec Co., Ltd (SHA: 603259, HKG: 2359) has disclosed that a group of shareholders plans to divest up to 3% of their holdings in the company. This translates to the auctioning of up to 88.68 million A shares in blocks, representing RMB 9.12 billion…
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Zai Lab Ltd Makes FcRn Antagonist Efgartigimod Available for Myasthenia Gravis Treatment
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Zai Lab Ltd (NASDAQ: ZLAB, HKG: 9688) has announced the availability of efgartigimod, the world’s first FcRn antagonist, via the Bo’Ao Lecheng Medical Tourism Pilot Zone for the treatment of myasthenia gravis (MG). Understanding Myasthenia GravisMyasthenia gravis is a rare and chronic autoimmune disease caused by the dysfunction of nerve…
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Bristol-Myers Squibb Launches Reblozyl in China for β-Thalassemia Treatment
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US pharmaceutical giant Bristol-Myers Squibb (BMS; NYSE: BMY) has announced the commercial launch of its first-in-class erythrocyte maturation agent, Reblozyl (luspatercept), in China. The product, filed by its subsidiary Celgene, received approval in China in January 2022 for the treatment of adult β-thalassemia patients who require regular red blood cell…
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China NT Pharma Group Company Ltd Inks Licensing Deal for Monoclonal Antibodies
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China-based China NT Pharma Group Company Ltd (HKG: 1011) has announced a potential acquisition agreement with an undisclosed US firm. Under the terms of the agreement, its wholly owned subsidiary, Green-Life Technology (Hong Kong) Co., Ltd, will obtain exclusive and permanent commercial licensing rights to several monoclonal antibodies (mAbs) for…
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Clover Biopharmaceuticals Initiates SCB-219M Clinical Study for CIT Treatment
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China-based Clover Biopharmaceuticals Ltd (HKG: 2197) has announced the first subject dosing in a Phase I clinical study for its in-house developed thrombopoietin receptor agonist, SCB-219M. This multi-center, dosage escalation and expansion study will evaluate the safety, tolerability, immunogenicity, pharmacokinetic characteristics, and efficacy of SCB-219M in CIT patients. Interim safety…
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Ferring and I-Mab Expand Olamkicept Collaboration for Inflammatory Diseases
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Swiss pharmaceutical company Ferring Pharmaceuticals has announced a strategic collaboration with China’s I-Mab Inc. (NASDAQ: IMAB) to further develop olamkicept, an interleukin-6 (IL-6) inhibitor targeting inflammatory bowel disease (IBD) and other inflammatory conditions. Originally discovered by Ferring, olamkicept was licensed to I-Mab in 2016 for development and commercialization in Asia,…
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Shanghai Henlius Partners with Organon for Global Biosimilar Commercialization
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China-based Shanghai Henlius Biotech, Inc. (HKG: 2696) has entered into a licensing and supply agreement with US-based Organon (NYSE: OGN), granting Organon exclusive commercialization rights to Henlius’s biosimilars of Perjeta (pertuzumab, HLX11) and Prolia/Xgeva (denosumab, HLX14). The deal excludes Greater China and covers global territories. Deal Structure and FinancialsThe agreement…
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BeiGene’s Brukinsa Faces Three-Month FDA Approval Delay for CLL/SLL Indication
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China-based biotech company BeiGene Inc. (Nasdaq: BGNE) will experience a three-month delay in its pursuit of US approval for its Bruton’s tyrosine kinase (BTK) inhibitor, Brukinsa (zanubrutinib), for the treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL). The US Food and Drug Administration (FDA) has pushed back the…
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Junshi Biosciences Receives NMPA Approval for Fourth-Generation EGFR Inhibitor WJ13404
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Shanghai-based biotech Junshi Biosciences (HKG: 1877, SHA: 688180) has received approval from China’s National Medical Products Administration (NMPA) to conduct a clinical study for WJ13404, a fourth-generation EGFR inhibitor developed in collaboration with Wigen Biomedicine. This approval positions Junshi Biosciences at the forefront of advanced non-small cell lung cancer (NSCLC)…
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Innovent Biologics Receives BPOM Approval for Bevagen in Indonesia
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China-based Innovent Biologics Inc. (HKG: 1801) has announced receiving indication approvals from Indonesia’s Badan Pengawas Obat dan Makanan (BPOM) for its Bevagen (bevacizumab), a biosimilar version of Avastin. This approval marks a significant milestone for Innovent as it expands its market presence in Southeast Asia. Approved IndicationsInnovent’s bevacizumab has been…
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Innovent Biologics’ IBI306 Accepted for Review by China’s NMPA for Hypercholesterolemia
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China-based Innovent Biologics Inc. (HKG: 1801) has announced that a New Drug Application (NDA) filing for its recombinant fully human anti-PCSK-9 monoclonal antibody (mAb) IBI306 has been accepted for review by the National Medical Products Administration (NMPA). The application covers the treatment of primary hypercholesterolemia (including heterozygous familial and non-familial…
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Clover Biopharmaceuticals Begins Phase III Trial for COVID-19 Booster SCB-2019
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China-based Clover Biopharmaceuticals Ltd (HKG: 2197) has announced the immunization of the first group of patients in a double-blind, randomized, controlled Phase III clinical study. The trial is assessing the safety and immunogenicity of its COVID-19 vaccine candidate SCB-2019 (CpG 1018/Alum) as a booster shot. Participants previously received two doses…
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InventisBio’s KRAS G12C Inhibitor D-1553 Earns CDE Breakthrough Therapy Status
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China-based InventisBio (Shanghai) Co., Ltd announced receiving breakthrough therapy designation (BTD) status for its KRAS G12C inhibitor D-1553 from the Center for Drug Evaluation (CDE), marking the first such recognition in China. Drug Profile and Clinical TrialsD-1553 is a highly efficient and selective KRAS G12C inhibitor undergoing a global multi-center…
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CANbridge Pharmaceuticals Presents Positive Phase I Data for CAN106 at EHA Congress
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China-based rare disease firm CANbridge Pharmaceuticals Inc. (HKG: 1228) released the latest data from a Phase I single-dose escalation study for its pipeline drug candidate CAN106, a long-acting monoclonal antibody (mAb) targeting C5 of the complement system. The results were unveiled at the European Hematology Association (EHA) congress in Singapore.…
