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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…
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China Resources Partners with Fosun Pharma to Expand Global Healthcare Footprint
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China Resources (Holdings) Co. Ltd (HKG: 3320) has entered into a strategic partnership with compatriot firm Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) in the healthcare industry. The collaboration aims to accelerate the global layout and industrial development of both companies through strategic and business collaborations in…
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NMPA Approves JW Therapeutics’ Carteyva for Recurrent Follicular Lymphoma
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The National Medical Products Administration (NMPA) has granted another indication approval to China-based JW Therapeutics’ (HKG: 2126) Carteyva (relmacabtagene autoleucel injection). The anti-CD19 autologous chimeric antigen receptor (CAR) T-cell immunotherapy product can now be used to treat recurrent or refractory (r/r) follicular lymphoma (FL) in adults after second-line or above…
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Innovent’s Cyramza Gains NMPA Approval for Hepatocellular Carcinoma
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Innovent Biologics Inc. (HKG: 1801) has announced that the supplementary Biologic License Application (sBLA) for its anti-tumor drug Cyramza (ramucirumab) in hepatocellular carcinoma (HCC) has been approved by the National Medical Products Administration (NMPA). The indication focuses on patients with alpha fetoprotein (AFP) ≥ 400 ng/mL who have previously been…
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Sciwind Biosciences Initiates US Phase I Study for GLP-1 Agonist XW014
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China-based Sciwind Biosciences Co., Ltd has announced the initiation and first patient dosing of a Phase I clinical study for its XW014 in the United States. The double-blind, randomized, placebo-controlled, single and multiple ascending dose study is designed to assess the safety, tolerability, food effects, pharmacokinetics, pharmacodynamics, and early treatment…
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Fujian Cosunter to Acquire UDCA Capsules Technology from Ruitailai
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China-based Fujian Cosunter Pharmaceutical Co., Ltd (SHE: 300436) has announced plans to enter into a technology transfer agreement with compatriot firm Fujian Ruitailai Pharmaceutical Technology Co., Ltd. Under the agreement, Cosunter will obtain all technologies, materials, and rights to Ruitailai’s ursodeoxycholic acid capsules (250mg) for RMB 13.5 million (USD 1.9…
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Fujian Cosunter Doses First Patient in Phase I Study of COVID-19 Drug GST-HG171
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China-based Fujian Cosunter Pharmaceutical Co., Ltd (SHE: 300436) has announced that the first patient has been dosed in a Phase I clinical study for its Category 1 drug candidate GST-HG171. The randomized, double-blind, placebo-controlled study is designed to assess the safety, tolerability, and pharmacokinetics of the drug in healthy Chinese…
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Salubris Pharmaceuticals’ First-in-Class Anti-Tumor Drug SAL008 Accepted by NMPA
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China’s Shenzhen Salubris Pharmaceuticals Co., Ltd (SHE: 002294) has announced that a clinical trial filing for its first-in-class anti-tumor biologic drug SAL008 has been accepted for review by the National Medical Products Administration (NMPA). The drug, indicated for advanced solid tumors, has previously entered Phase I clinical trials in Europe.…
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Roche’s Subcutaneous Herceptin Approved in China for HER2-Positive Breast Cancer
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Swiss pharmaceutical giant Roche’s (SWX: ROG) Herceptin (trastuzumab, subcutaneous injection) has been approved in China for the treatment of early and metastatic HER2-positive breast cancer in combination with chemotherapy. This approval marks a significant advancement in the treatment options available for patients with HER2-positive breast cancer, offering a more convenient…
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CDE Releases 63rd Batch of Chemical Generic Reference Preparations
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The Center for Drug Evaluation (CDE) has released the 63rd batch of chemical generic reference preparations, adding 22 new specifications and updating information for 39 previously published specifications. This update is part of the CDE’s ongoing efforts to streamline the approval process for generic drugs and ensure the availability of…
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Jiangsu Launches Sunshine Procurement Platform for Drugs and Medical Consumables
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Jiangsu province has launched its drugs and medical consumables sunshine procurement services website, providing a comprehensive platform for interested parties to access policy updates, gather information about products for online procurement, download national and provincial volume-based procurement (VBP) product lists, query drugs and medical consumables online procurement prices, and track…
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Merck’s Keytruda Gains 9th Indication Approval in China for Hepatocellular Carcinoma
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US major Merck Sharp & Dohme’s (MSD, NYSE: MRK) programmed death-1 (PD-1) inhibitor Keytruda (pembrolizumab) has obtained its 9th indication approval from China’s National Medical Products Administration (NMPA). The drug can now be used as a monotherapy to treat hepatocellular carcinoma (HCC) previously treated with sorafenib or oxaliplatin. Approval Based…
