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Azvudine Included in China’s COVID-19 Treatment Protocol
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The National Healthcare Commission and the National Administration of Traditional Chinese Medicine have released a notification indicating the inclusion of Henan Genuine Biotech Co., Ltd’s COVID-19 therapy azvudine in the Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (9th Edition). The drug is now approved for the treatment of adult…
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NMPA Approves IND Filing for Henan Genuine Biotech’s Long-Acting HIV Drug CL-197
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China-based Henan Genuine Biotech Co., Ltd’s investigational new drug (IND) filing for its oral long-acting HIV drug candidate CL-197 has been approved by the National Medical Products Administration (NMPA). CL-197 is a novel nucleoside reverse transcriptase inhibitor (NRTI) that inhibits reverse transcription by simulating endogenous purine nucleotides, thus having potential…
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WuXi Biologics Partners with Toregem BioPharma on Anti-USAG-1 Monoclonal Antibody
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China-based Contract Research, Development, and Manufacturing Organization (CRDMO) WuXi Biologics (HKG: 2269) has entered into a memorandum of understanding (MOU) with Japan-based startup Toregem BioPharma. The collaboration focuses on the development of Toregem’s TRG035, an anti-USAG-1 monoclonal antibody being developed to treat congenital tooth loss. This partnership aims to leverage…
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BeiGene Partners with Amoy Diagnostics for Companion Diagnostics Development
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China-based biotech BeiGene Inc. (HKG: 6160, SHA: 688235, NASDAQ: BGNE) has entered into a partnership with compatriot firm Amoy Diagnostics Co., Ltd (AmoyDx). The collaboration allows AmoyDx’s HER2 gene IHC (immunohistochemistry) and FISH (fluorescence in situ hybridization) detection kits to support BeiGene’s filings for its drugs as companion diagnostics (CDx).…
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NMPA Approves Beijing Union Strong’s Intracranial Aneurysm Surgical Planning Software
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The National Medical Products Administration (NMPA) has approved the marketing of Beijing Union Strong Technology Co., Ltd’s intracranial aneurysm surgical planning software. This approval marks a significant advancement in the field of neurointerventional surgery, offering enhanced planning capabilities for aneurysm treatments. Software Features and FunctionalityThe product consists of an application…
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Aier Eye Hospital Group Plans IPO on ChiNext Board
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China-based ophthalmic medical services provider Aier Eye Hospital Group Co., Ltd (SHE: 300015) is set to conduct an initial public offering (IPO) of 133 million shares at RMB 26.49 (USD 3.70) per share on the Shenzhen Stock Exchange’s ChiNext board. The offering is expected to raise RMB 3.54 billion (USD…
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BeiGene Partners with Immune-Onc for Clinical Development of Myeloid Checkpoint Inhibitors
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China-based biotech BeiGene (HKG: 6160, SHA: 688235, NASDAQ: BGNE) has entered into a clinical study cooperation and supply agreement with US-headquartered Immune-Onc Therapeutics. The collaboration aims to assess Immune-Onc’s first-in-class myeloid checkpoint inhibitors IO-108 and IO-202 in combination with BeiGene’s anti-PD-1 antibody, tislelizumab, as part of its clinical development programs…
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Cyagen Biosciences Partners with Neurophth for Ophthalmology AAV Capsid Development
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Cyagen Biosciences, a provider of custom-engineered mouse and rat models with operations in the US and China, has entered into a partnership valued at RMB 1 billion (USD 139.5 million) with China-based gene therapy specialist Neurophth Biotechnology Ltd. The collaboration aims to leverage Cyagen’s professional gene therapy AI high-throughput adeno-associated…
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IASO Biotherapeutics Licenses CD19 Binder to Cabaletta Bio for Autoimmune Diseases
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China-based IASO Biotherapeutics has announced a licensing agreement with US firm Cabaletta Bio Inc. (NASDAQ: CABA), granting the latter an exclusive, worldwide license to develop, manufacture, and commercialize a clinically validated fully-human CD19 binder. The binder will be used in a product designed to modify T cells for the treatment…
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Henlius Biotech’s HanBeiTai Biosimilar Accepted for Review by CDE
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Shanghai Henlius Biotech Inc. (HKG: 2696) has announced that a supplementary Biologic License Application (sBLA) for its HanBeiTai, a biosimilar of bevacizumab, has been accepted for review by the Center for Drug Evaluation (CDE). The targeted indications for this application include cervical cancer, epithelial ovarian cancer, fallopian tube cancer, and…
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Shanghai Launches High-Quality Development Pilot for Public Hospitals
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The Shanghai Municipal Health Commission (SHC) has released a notification regarding the public hospital high-quality development pilot project initiated by the office of Shanghai’s “Deepening Medical Reforms Leading Group.” The project aims to enhance the quality and efficiency of public healthcare services in the city. Selection of Pilot UnitsBased on…
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NMPA Introduces Electronic Certificates for Biologics and Narcotic Drugs
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The National Medical Products Administration (NMPA) has released a notification regarding the initiation of electronic certificates for biologic product releases and electronic approvals of narcotic drugs, as well as the establishment of a psychotropic substances study program. These measures aim to streamline regulatory processes and enhance efficiency in the management…
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CDE Releases Draft Guidelines for Tumor Therapeutic Vaccine Clinical Trials
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The Center for Drug Evaluation (CDE) has released the “Tumor Therapeutic Vaccines Clinical Trial Technical Guidelines” (draft proposal), soliciting public feedback until November 8. These guidelines aim to provide a framework for the development and evaluation of tumor therapeutic vaccines, a class of products designed to control and kill tumor…
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SprintRay Raises Over USD 100M in Series D Financing for Dental 3D Printing
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Zhejiang-based SprintRay Co., a one-stop digital chair side solution provider for dental institutions, has reportedly raised over USD 100 million in a Series D financing round. The round was led by SoftBank Vision Fund 2, with contributions from Yiheng Capital and ZWC Partners, alongside existing investors CDBI Partners and Marathon…
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Pfizer’s Zavicefta Approved in China for Pediatric Complex Intra-Abdominal Infections
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US-based pharmaceutical giant Pfizer (NYSE: PFE) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its avibactam sodium + ceftazidime product, marketed under the brand name Zavicefta, in China. The indication is for children three months and older with complex intra-abdominal infection (cIAI).…
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HutchMed Initiates Phase II/III Study of Sovleplenib for Warm AIHA
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China-based Hutchison China Meditech (HutchMed; NASDAQ: HCM, HKG: 0013) has announced the initiation of a Phase II/III study for its sovleplenib (HMPL-523) in adult patients with warm antibody autoimmune hemolytic anemia (wAIHA) in China. The first patient was dosed on September 30. This marks a significant step forward in the…
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Harbour BioMed Licenses Batoclimab to CSPC’s NBP Pharma for Greater China
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Harbour BioMed (HKG: 2142), a biotech company operating out of the United States, the Netherlands, and Suzhou (China), has announced a licensing agreement with CSPC Pharmaceutical Group Co., Ltd’s (HKG: 1093) wholly-owned subsidiary Shijiazhuang Pharma Group NBP Pharmaceutical (Shijiazhuang) Co. Ltd. The agreement grants NBP Pharma exclusive development, manufacturing, and…
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Guangdong Zhongsheng Receives USPTO Patent for FGFR4 Inhibitor ZSP1241
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China-based Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317) has announced receiving a patent award from the United States Patent and Trademark Office (USPTO) for ZSP1241, a home-grown fibroblast growth factor receptor 4 (FGFR4) inhibitor. The patent, titled “Salt form and crystal form of compound as FGFR4 inhibitor and preparation method…
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Simcere Completes Enrollment for Phase III Study of CDK4/6 Inhibitor in mTNBC
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China-based Simcere Pharmaceutical Group (HKG: 2096) has announced the completion of first-line enrollment for its Phase III PRESERVE 2 study of the CDK4/6 inhibitor Cosela (trilaciclib) in metastatic triple-negative breast cancer (mTNBC). The study enrolled 187 patients, with interim overall survival analysis expected during the second half of 2023. PRESERVE…
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Hengrui Medicine’s Pyrotinib Filing Accepted for Review by NMPA
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China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced that its supplementary market filing for its tyrosine kinase inhibitor (TKI) pyrotinib has been accepted for review by the National Medical Products Administration (NMPA). The targeted indication is for use in combination with trastuzumab plus docetaxel in advanced, recurrent or…
