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RemeGen’s Telitacicept Shows Positive Results in Phase II Myasthenia Gravis Study
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China-based RemeGen Co., Ltd (HKG: 9995, SHA: 688331) has released data from a Phase II clinical study for its novel fusion protein telitacicept in Chinese patients with myasthenia gravis (MG), showing positive results. The study demonstrated significant improvements in patient conditions and good safety profiles. Study Design and ResultsThe multicenter,…
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Immunochina Pharmaceuticals Raises Funds for Gene Therapy Development
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Beijing-based gene therapy specialist Immunochina Pharmaceuticals has reportedly raised “hundreds of millions” of renminbi in a Series D+ financing round, following a Series D financing round at the same scale in November 2021. The round was led by ZGC Science City and Beijing Innovation Industry Investment. The proceeds will be…
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BGI Genomics Receives NMPA Approval for Chromosome Aneuploidy Detection Kit
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China-based genomics firm BGI Genomics Co., Ltd (SHE: 300676), the Shenzhen-listed subsidiary of BGI Group, has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its chromosome aneuploidy detection kit (combined probe anchoring polymerization sequencing method). This marks a significant milestone in the company’s efforts to advance…
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NMPA Suspends GSK’s Avodart Amid Inspection Findings
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The National Medical Products Administration (NMPA) has decided to suspend the import, sales, and use of GlaxoSmithKline’s (GSK, NYSE: GSK) Avodart (dutasteride) in China. The drug had previously won a spot during the fifth round of volume-based procurement (VBP). However, recent overseas non-on-site inspections revealed that not all batches of…
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Antengene’s ATG-017 Gets FDA Approval for Phase I Clinical Study
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Antengene Corporation has announced receiving approval from the US Food and Drug Administration (FDA) to initiate a Phase I clinical study for its ATG-017, an extracellular regulated protein kinase 1/2 (ERK1/2) inhibitor. The Shanghai-based biotech company will commence the joint part of the Phase I ETASER study, assessing the safety,…
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China Grand’s STC3141 Reaches Primary Endpoint in ARDS Phase Ib Study
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China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced that the Phase Ib clinical study (NCT05000671) for its drug candidate STC3141 in acute respiratory distress syndrome (ARDS) has reached its primary endpoint. This marks a significant step forward in the development of the drug for this critical condition. Phase Ib…
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Allogene Overland Biopharm Completes State-of-the-Art AlloCAR T Facility in Shanghai
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Allogene Overland Biopharm, a joint venture between Overland Pharmaceuticals and Allogene Therapeutics, Inc. (NASDAQ: ALLO), has announced the completion of its state-of-the-art AlloCAR T manufacturing facility in Shanghai, China. This marks a significant milestone in the company’s efforts to expand its cell therapy production capabilities. State-of-the-Art GMP FacilityThe new 68,000…
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Shandong Buchang Partners with REMD Bio for Bispecific Antibody Development
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China-based Shandong Buchang Pharmaceuticals Co., Ltd (SHA: 603858) has announced a co-development and licensing agreement with US-headquartered REMD Biotherapeutics Inc. and its subsidiary Sichuan Luzhou Buchang Biopharmaceutical Co., Ltd. Under the agreement, REMD Bio will grant Luzhou Buchang an exclusive license for REMD-290 in mainland China and Russia. Agreement Details…
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Eucure Biopharma Partners with ISU ABXIS to Develop Tri-Specific Antibodies Using YH003
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Eucure Biopharma, a wholly-owned subsidiary of Sino-US contract research organization (CRO) Biocytogen, has entered into a partnership agreement with South Korea-based ISU ABXIS Co., Ltd (ISU ABXIS, KOSDAQ: 086890). Under the agreement, ISU ABXIS has been granted the use of Eucure’s YH003 sequence to develop multiple tri-specific antibodies for the…
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Zhejiang Medicine’s ARX788 Advances to Phase II Study for HER2-Positive Cholangiocarcinoma
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China-based Zhejiang Medicine Co., Ltd (SHA: 600216) has received approval from the National Medical Products Administration (NMPA) to conduct a Phase II clinical study assessing the efficacy and safety of its ARX788, an anti-HER2 monoclonal antibody conjugate with AS269, in patients with HER2-positive cholangiocarcinoma. This approval marks a significant step…
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Simcere’s SIM0235 Begins US Phase I Trial for Anti-Tumor Therapy
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China-based Simcere Pharmaceutical Group (HKG: 2096) has announced the enrollment of the first patient in a Phase I clinical study for its novel anti-tumor drug candidate SIM0235 (formerly SIM1811-03) in the United States. This marks a significant milestone in the global development of the drug. SIM0235: Mechanism and PotentialSIM0235 is…
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China’s National Plan to Combat Microbial Drug Resistance Released
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The National Health Commission (NHC), Ministry of Education, Ministry of Science and Technology, and 10 other bureaus have released the “National Action Plan for Combating Microbial Drug Resistance (2022-2025).” The plan outlines general requirements, main objectives, key tasks, and security measures to address the growing challenge of microbial drug resistance.…
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Sanofi’s Q3 Sales Rise 9% on Dupixent and Flu Vaccine
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French pharmaceutical major Sanofi (NASDAQ: SNY) released its Q3 2022 financial report, recording EUR 12.482 billion (USD 12.394 billion) in global net sales, up 9% year-on-year (YOY) in constant exchange rates. The growth was driven by strong performances from Dupixent (dupilumab) and its flu vaccine. Within the total sales, the…
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Novartis’ Cosentyx Gains Approval for New Doses in China
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has announced receiving marketing approval for two new specifications of Cosentyx (secukinumab) in China. The new 300mg and 75mg prefilled syringe forms are approved for pediatric psoriasis in patients aged six years and above with moderate to severe plaque psoriasis eligible for systemic treatment…
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XtalPi Partners with Janssen to Accelerate Drug Discovery
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China-based XtalPi, Inc. has announced a research collaboration with Janssen Pharmaceutica NV, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, to deliver chemical matter with validated binding affinities and desirable property profiles. The collaboration was facilitated by Johnson & Johnson Innovation LLC. Collaboration DetailsUnder the agreement, XtalPi will…
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NMPA Approves Kyowa Hakko Kirin’s Mogamulizumab for Sezary Syndrome and Mycosis Fungoides
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Kyowa Hakko Kirin China Pharmaceutical Co., Ltd’s mogamulizumab, a first-in-class chemokine receptor type 4 (CCR4) monoclonal antibody (mAb), has been approved by the National Medical Products Administration (NMPA) for the treatment of adult patients with recurrent or refractory Sezary syndrome (SS) or advanced (III/IV) mycosis fungoides (MF) who have previously…
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NMPA Grants Second Approval to Henlius’ Serplulimab for Lung Cancer
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The National Medical Products Administration (NMPA) has granted a second marketing approval to HaiSiZhuang (serplulimab), a programmed death-1 (PD-1) inhibitor developed by Shanghai Henlius Biotech (HKG: 2696). The drug is now approved for the treatment of first-line squamous non-small cell lung cancer (sqNSCLC). Previous Approvals and Clinical ProgressSerplulimab was initially…
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Innovent’s CLDN18.2 ADC IBI343 Begins Phase I Trial in Australia
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Innovent Biologics Inc. (HKG: 1801) has announced the first subject dosing in a Phase I clinical study for its IBI343, a CLDN18.2 antibody drug conjugate (ADC), in Australia. This marks the first ADC from the Chinese biotech company to enter clinical trials. Phase I Clinical Study DesignThe open-label, multi-center Phase…
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Ascletis Signs Pact with Pfizer China for Ritonavir Tablets
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Ascletis Pharma Inc. (HKG: 1672) announced that its wholly-owned subsidiary Ascletis Pharmaceuticals Co., Ltd has entered into a five-year license and supply agreement with Pfizer Investment Co., Ltd, the China unit of US-based Pfizer Inc. The agreement relates to the ritonavir 100 mg film-coated tablet, a key component of Paxlovid…
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Eli Lilly Cancels Licensing Deal for Fosun Pharma’s FCN-338
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Shanghai Fosun Pharma (Group) Co., Ltd (SHA: 600196, HKG: 2196) announced that its US partner Eli Lilly has decided to cancel the licensing deal struck with its subsidiary Fochon Pharmaceuticals Ltd in relation to FCN-338, a selective B-cell lymphoma 2 (Bcl-2) small-molecule inhibitor. The decision was cited as a “product…
