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Aosaikang’s ASKG915 Accepted for FDA Review, Targets Advanced Solid Tumors
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Beijing Aosaikang Pharmaceutical Co., Ltd (SHE: 002755) has announced that its clinical trial filing for the Category 1 biologic product ASKG915 has been accepted for review by the US FDA. This marks a significant step forward in the development of ASKG915, a bifunctional fusion protein targeting programmed-death 1 (PD-1) and…
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Legend Biotech Receives IND Approval for LB2102 CAR-T Therapy
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China-based Legend Biotech Corporation (NASDAQ: LEGN) has announced receiving Investigational New Drug (IND) approval for its LB2102, an autologous chimeric antigen receptor-T (CAR-T) therapy designed to treat adult patients with small cell lung cancer (SCLC) by targeting DLL3, a cell surface protein highly expressed in SCLC. Clinical Study DesignThe open-label…
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Sun-Novo Pharma Gains NMPA Approval for STC007 Clinical Study in CKD-aP
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China-based Beijing Sun-Novo Pharmaceutical Research Co., Ltd (SHA: 688621) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a clinical study assessing its Category 1 drug candidate STC007. The study will focus on moderate to severe chronic kidney disease-associated pruritus (CKD-aP) in adults receiving hemodialysis (HD).…
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JD Healthcare Partners with Jiangsu Yuyue for Medical Device Collaboration
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JD Healthcare, a unit of China’s e-commerce giant JD.com (NASDAQ: JD), has announced a partnership with compatriot firm Jiangsu Yuyue Medical Equipment Inc. (SHE: 002223). The collaboration aims to leverage JD Healthcare’s healthcare supply chain and service advantages, combined with Yuyue Med’s expertise in the medical device field, to enhance…
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Junshi Biosciences’ JunMaiKang Approved by NMPA for Multiple Indications
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China-based Junshi Biosciences (HKG: 1877, SHA: 688180) has announced that its JunMaiKang, a biosimilar version of AbbVie’s auto-immune disease drug Humira (adalimumab) co-developed by Mabwell, has been approved by the National Medical Products Administration (NMPA) for the treatment of Crohn’s disease, uveitis, polyarticular juvenile idiopathic arthritis, pediatric plaque psoriasis, and…
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Hengrui Pharmaceuticals Receives FDA ANDA Approval for Gadobutrol Generic
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China-based Jiangsu Hengrui Pharmaceuticals (SHA: 600276) has announced receiving Abbreviated New Drug Application (ANDA) status from the US FDA for its generic version of Bayer’s Gadovist (gadobutrol injection), marking the first generic approval of this kind in the United States. This approval positions Hengrui to expand its presence in the…
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Fosun Pharma’s Bivalent COVID-19 Vaccine Comirnaty Authorized in Hong Kong
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Shanghai Fosun Pharmaceutical Group Co (SHA: 600196) has announced obtaining emergency use authorization (EUA) in Hong Kong for its bivalent COVID-19 original strain/Omicron variant BA.4-5 vaccine Comirnaty (BNT162b2) as a booster shot for populations aged 12 and above. This marks a significant step in the company’s efforts to provide enhanced…
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IASO Biotherapeutics Reports Positive Phase I Results for CAR-T Therapy in NMOSD
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China-based IASO Biotherapeutics has announced the interim results of a Phase I investigator-initiated-trial (ITT) for its BCMA chimeric antigen receptor autologous T (CAR-T) cell therapy equecabtagene autoleucel (CT103A) in neuromyelitis optica spectrum disorder (NMOSD). The study (NCT04561557) is the world’s first to assess a CAR-T therapy in aquaporin 4 (AQP4)-mediated…
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ViVest Medical Raises Funds for Wearable Cardioverter Defibrillator Development
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Suzhou-based device maker ViVest Medical Technology Co., Ltd has reportedly raised “hundreds of millions” of RMB in a Pre-Series B financing round led by SDIC Unity Capital. Other investors included Dingxin Capital and Anji Liangshan State-owned Holdings. The proceeds will be used to advance a clinical study for its fully…
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Mabwell Receives Approval for Clinical Study of 9MW3011 in Polycythemia Vera
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China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has announced receiving approval to conduct a clinical study assessing its Category 1 drug candidate 9MW3011 in polycythemia vera. The drug’s clinical trial filing was accepted for review in China last month, marking a significant step forward in its development. Drug Profile9MW3011…
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Hotgen Biotech Receives FDA EUA for COVID-19 Antigen Home Test
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China-based Hotgen Biotech Co., Ltd (SHA: 688068) has announced receiving Emergency Use Authorization (EUA) from the US FDA for its Hotgen COVID-19 antigen home test. This approval marks a significant milestone in the company’s efforts to provide accessible and convenient testing solutions for the novel Coronavirus (2019-nCoV). Test ProfileThe Hotgen…
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Wolters Kluwer Partners with China’s NCID to Advance Infectious Disease Diagnosis
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Holland-based information and software solutions provider Wolters Kluwer has announced a partnership with China’s National Center for Infectious Disease (NCID). The collaboration aims to enhance evidence-based diagnosis and treatment in the infectious disease field through joint efforts in discipline development and talent cultivation. Financial details of the partnership were not…
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Fapon Biotech Partners with CR Pharma to Develop IVD Open Platform Ecosystem
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China-based biotech Fapon Biotech Inc. has announced a partnership with China Resources Pharmaceutical Commercial Group Medical Device Co., Ltd to develop an in vitro diagnostics (IVD) open platform ecosystem. The collaboration aims to enhance the development and market presence of IVD solutions. Financial details of the partnership were not disclosed.…
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Henlius’ Serplulimab Phase III Study Approved in Spain for LS-SCLC
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China-based Shanghai Henlius Biotech (HKG: 2696) has announced that its global, multi-center Phase III clinical study (NCT05353257) for HaiSiZhuang (serplulimab) in limited stage small-cell lung cancer (LS-SCLC) has been approved in Spain, a member country of the European Union (EU). The study will assess the PD-1 inhibitor combined with chemotherapy…
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Hainan Poly Pharm Wins Finland Approval for Generic Cytovene-IV
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China-based Hainan Poly Pharm Co., Ltd (SHE: 300630) has announced receiving marketing approval from the Finland National Agency for Medicines for its generic version of Roche’s Cytovene-IV (ganciclovir). The approval marks a significant expansion of the company’s market presence in Europe. The targeted indications include the treatment of cytomegalovirus retinitis…
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Kangtai Biological Completes Phase III Clinical Data Analysis for COVID-19 Vaccine
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China-based Shenzhen Kangtai Biological Products Co., Ltd (SHE: 300601) has announced the completion of the analysis of key Phase III clinical data for its in-house developed COVID-19 inactivated vaccine (Vero cells). The study assessed the vaccine’s efficacy and safety in a global, multi-center, randomized, double-blind, placebo-controlled trial. Study DetailsThe Phase…
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Fapon Biotech Partners with Roche Diagnostics at China International Import Expo
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China-based biotech Fapon Biotech Inc. has announced a partnership with Swiss major Roche Diagnostics at the 5th China International Import Expo (CIIE). The collaboration aims to deepen cooperation in the field of raw material product technical services and molecular diagnostics. The two companies plan to fully integrate their respective resources…
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China’s Jiangsu Bioda Gains NMPA Approval for Innovative Artificial Blood Vessel
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The National Medical Products Administration (NMPA) has granted marketing approval to China-based Jiangsu Bioda Life Science Co Ltd’s innovative artificial blood vessel. This marks a significant milestone in the development and commercialization of advanced medical devices in China. Product ProfileThe artificial blood vessel is primarily composed of PET thread and…
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Visen Pharmaceuticals Publishes Phase III Data for Lonapegsomatropin in Growth Hormone Deficiency
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Visen Pharmaceuticals, a China-based joint venture between Denmark-headquartered Ascendis Pharma and Chinese healthcare-focused investment firm Vivo Capital, has published primary data from a pivotal Phase III study for its lonapegsomatropin, also known as TransCon hGH, a once-weekly long-acting growth hormone. The study evaluated the efficacy and safety of lonapegsomatropin in…
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RongCan Biotech Raises Pre-Series A Funding for mRNA Therapeutics Development
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China-based nucleic acid-based therapeutics developer RongCan (Shanghai) Biotech Co., Ltd has reportedly raised “tens of millions” of renminbi in a Pre-Series A financing round led by a “reputational healthcare fund.” The proceeds will be used to accelerate product research and development (R&D), team building, and clinical studies for leading pipelines.…
