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Hybio Pharmaceutical’s Liraglutide Biosimilar Withdrawn from NMPA Filing
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China-based Hybio Pharmaceutical Co., Ltd (SHE: 300199) has announced that the National Medical Products Administration (NMPA) has approved its application to withdraw the market filing for its biosimilar version of Novo Nordisk’s (NYSE: NVO) Victoza (liraglutide). This decision comes as part of a strategic adjustment in response to policy and…
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Sinotau Pharmaceutical Secures Over RMB 1.1 Billion in Latest Financing Round
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Sinotau Pharmaceutical Group, a prominent nuclear medicine (radiopharmaceutical) company headquartered in Beijing, has reportedly raised over RMB 1.1 billion (USD 150 million) in a new financing round. This capital influx is set to bolster the company’s research and development efforts, as well as the clinical application of diagnostic and therapeutic…
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Innovent Biologics and IASO Biotherapeutics’ Fucaso Approved for Multiple Myeloma Treatment in China
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Innovent Biologics, Inc. (HKG: 1801) and IASO Biotherapeutics have announced that they have received marketing approval from the National Medical Products Administration (NMPA) for their jointly developed and commercialized product, Fucaso (equecabtagene autoleucel). This approval positions Fucaso as the first fully-human BCMA-directed chimeric antigen receptor (CAR) T cell therapy approved…
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SciClone Pharmaceuticals’ Danyelza Officially Launched in China for Neuroblastoma Treatment
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SciClone Pharmaceuticals Inc. (Nasdaq: SCLN) has reached a significant milestone with the first prescription of Danyelza (naxitamab) in China, signifying its official commercial launch. Danyelza, a GD2-targeted monoclonal antibody, was originally developed by Y-mAbs Therapeutics Inc. and was fast-tracked for marketing approval in China in November 2020. Licensing Agreement and…
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Zai Lab’s Vyvgart Receives NMPA Approval as First-in-Class FcRn Antagonist for Myasthenia Gravis
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Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688), a China-based biopharmaceutical company, has announced that the National Medical Products Administration (NMPA) has approved its Biologics License Application (BLA) for Vyvgart (efgartigimod alfa injection). Vyvgart, a first-in-class neonatal Fc receptor (FcRn) antagonist, is now approved for use as an add-on to standard…
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InnoCare Pharma and Keymed Biosciences Initiate Clinical Trial for ICP-B02 with First Subcutaneous Injection
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InnoCare Pharma (HKG: 9969; SHA: 688428) and Keymed Biosciences Inc., (HKG: 2162) have announced a significant milestone in their joint development of ICP-B02 (CM355), a bispecific antibody (BsAb) targeting CD20 and CD3. The first subcutaneous injection administration has been successfully administered to a Chinese patient, marking a new route of…
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Jiangsu Hengrui Medicine Gets NMPA Approval for HRS-4357 Clinical Study in Prostate Cancer
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading China-based pharmaceutical company, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its Category 1 radiotherapeutic drug, HRS-4357. This novel molecule is under development for the treatment of prostate specific…
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Sichuan Biokin Pharmaceutical Gets FDA Approval for BL-B01D1 Clinical Study
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a China-based pharmaceutical company, has announced that it has received the green light from the US Food and Drug Administration (FDA) to conduct a clinical study for its drug candidate, BL-B01D1. This in-house developed antibody-drug conjugate (ADC) targets EGFR and HER3, key drivers…
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RareStone Group’s Pitolisant Earns Priority Review Status for Narcolepsy Treatment in China
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The Center for Drug Evaluation (CDE) website in China has indicated that RareStone Group, a China-based rare disease specialist formerly known as Citrine Medicine, has secured priority review status for its in-licensed drug candidate, pitolisant. This status is awarded for the drug’s potential as a treatment for excessive daytime drowsiness…
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Joincare Pharmaceutical Initiates Phase III Study for Anti-IL-17A mAb in Plaque Psoriasis
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China-based Joincare Pharmaceutical Group Industry Co., Ltd (SHA: 600380) has announced the initiation of a Phase III clinical study for its anti-IL-17A monoclonal antibody (mAb) in the treatment of moderate to severe plaque psoriasis. The study, which was approved in China in February 2020, marks a significant step forward in…
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Bio-heart’s Iberis-HTN Study Shows Promising Results in Treating Primary Hypertension
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China-based Bio-heart Biological Technology Co., Ltd. (HKG: 2185) and its holding subsidiary Angiocare have announced the clinical results for the Iberis-HTN trial at the China Interventional Therapeutics 2023 conference. Iberis-HTN is a prospective, multicenter, blinded, randomized controlled trial designed to evaluate the safety and efficacy of the Iberis Multi-Electrode Renal…
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Sisram Medical’s Alma Lasers Acquires PhotonMed International Ltd, Expanding Global Presence
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Sisram Medical Ltd (HKG: 1696), an Israel-based company and part of the Fosun Pharmaceutical Group (SHA: 600196), has announced that its wholly-owned subsidiary, Alma Lasers Ltd (HKG: 1696), has closed a deal to fully acquire PhotonMed International Ltd, a leading distributor of energy source equipment in China. This acquisition is…
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Beijing Sun-Novo and Zhejiang Anglikang Enter Licensing Agreement for Hypertension Drug Candidate NHKC-1
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Beijing Sun-Novo Pharmaceutical Research Co., Ltd (SHA: 688621) has announced a significant licensing agreement with fellow Chinese firm Zhejiang Anglikang Pharmaceutical Co. Ltd (SHE: 002940) concerning Sun-Novo’s drug candidate, NHKC-1. This development marks a collaborative effort between the two companies to co-develop a treatment for primary hypertension. NHKC-1: A Drug…
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ZSP1273 by Guangdong Zhongsheng Pharma Shows Promise in Phase III Flu Treatment Study
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Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317), a China-based pharmaceutical company, has announced preliminary top-line data from a Phase III clinical study for its Category 1 drug, ZSP1273, in adults with simple influenza A. The randomized, double-blind study, conducted across over 80 centers in China, compared the effects of ZSP1273…
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Hansoh Pharmaceutical’s Phenylheptal Peptide Receives NMPA Approval for Anemia Treatment
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The National Medical Products Administration (NMPA) has issued a marketing approval for China-based Hansoh Pharmaceutical Group Co., Ltd’s (HKG: 3692) Category 1 product, phenylheptal peptide. This drug is indicated for the treatment of anemia in adult non-dialysis patients who are not receiving erythropoiesis stimulator (ESA) treatment, and in adult dialysis…
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Sinocelltech Group Receives NMPA Approval for Bevacizumab Biosimilar for Multiple Cancers
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China-based Sinocelltech Group Ltd (SHA: 688520) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its bevacizumab biosimilar. This biosimilar will be used to treat a range of cancers including metastatic colorectal cancer (CRC), recurrent glioblastoma, advanced metastatic or recurrent non-small cell lung…
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Cornerstone Robotics Secures RMB 800 Million in Funding for Surgical Robot Development
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Cornerstone Robotics, a leading surgical robot developer based in Shenzhen, has reportedly raised RMB 800 million (USD 110 million) in its latest financing round. The investment was led by BridgeOne Capital and Lenovo Capital, with participation from existing investors Tsing Song Capital, Meituan LONG-Z, Qiming Venture Partners, Lilly Asia Ventures,…
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Huadong Medicine Receives NMPA Approval for DR30206 Clinical Study in Advanced Solid Tumors
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its injectable DR30206, a Category 1 biologic product, in the treatment of advanced solid tumors. DR30206: A Promising Antibody Fusion Protein Targeting PD-L1,…
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Sinocelltech Group Receives NMPA Approval for COVID-19 Vaccine Bridging Phase II Study
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China-based Sinocelltech Group Ltd (SHA: 688520) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a bridging Phase II clinical study. The study will assess the safety and immunogenicity of SCTV01E-2, an S trimer protein vaccine developed to combat COVID-19. This vaccine is designed for individuals…
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Jiangsu Hengrui Pharmaceuticals Gets NMPA Approval for Phase III Studies of Gallium Edotreotide Injection
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with Phase III clinical studies for its gallium [68Ga] edotreotide injection and gallium [68Ga] edotreotide injection preparation kit. Gallium [68Ga]…
