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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…
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Convalife and Jointown Partner for Global Drug Development and Commercialization
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Shanghai-based Convalife Pharmaceuticals has entered into a strategic partnership with fellow Chinese firm Jointown Pharmaceutical Group Co., Ltd (SHA: 600998) to collaborate on new drug development and the global research, development, and commercialization of related products. The partnership aims to leverage the strengths of both companies to advance innovative cancer…
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Eli Lilly’s Retevmo Wins First China Approvals for RET-Driven Cancers
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Eli Lilly & Co (NYSE: LLY) has secured its first approvals in China for Retevmo (selpercatinib), a RET kinase inhibitor, across three indications. The drug is now approved for the treatment of RET gene fusion-positive locally advanced or metastatic non-small cell lung cancer (NSCLC), RET-mutated advanced or metastatic medullary thyroid…
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VectorBuilder Raises $56.6M in Series C to Expand Life Science R&D
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Guangzhou-based VectorBuilder, a genetic engineering specialist incubated by the state-owned Guangzhou Industrial Investment and Capital Operation Holding Group, has reportedly raised RMB 410 million ($56.6 million) in a Series C financing round. The funding round saw participation from investors including Guangzhou Industrial Investment and Capital Operation, Legend Capital, Yuexiu Industry…
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WuXi Biologics Removed from US Unverified List Amid Ongoing Restrictions
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The US Commerce Department’s Bureau of Industry and Security (BIS) has updated its Unverified List (UVL), removing WuXi Biologics (HKG: 2269), a contract research organization (CRO) based in Wuxi, China. However, the US authorities have added 31 additional Chinese companies and universities to the list, including Shanghai Tech University, University…
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India Launches Anti-Dumping Investigation Against Chinese Imports of Metronidazole
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The Union Ministry of Commerce and Industry in India has initiated an anti-dumping investigation into imports of the antibiotic metronidazole, following a complaint filed by Aarti Drugs Ltd., one of the largest manufacturers of the drug in the country. Complaint DetailsAarti Drugs alleges that Chinese companies aredumping metronidazole at prices…
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China’s NMPA Proposes Reforms to Enhance Radiopharmaceutical Review and Approval
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China’s National Medical Products Administration (NMPA) has released a draft proposal titled “Opinions on Reforming and Improving the Administration of Review and Approval of Radiopharmaceuticals,” seeking public feedback. The document outlines a series of reforms aimed at enhancing the regulatory framework for radiopharmaceuticals in the country. Expanding Expertise in Radiopharmaceutical…
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Ark Biosciences’ Ziresovir Shows Positive Results in Phase III AIRFLO Study for RSV Infection
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China-headquartered Ark Biosciences has announced positive results from the Phase III AIRFLO study for its novel antiviral drug ziresovir (AK0529). The study evaluated the efficacy and safety of ziresovir in hospitalized infants with respiratory syncytial virus (RSV) infection. The drug achieved its primary endpoint of a significant reduction in symptom…
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Pfizer’s Talzenna Shows Positive Results in Phase III TALAPRO-2 Study for mCRPC
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US-based pharmaceutical giant Pfizer (NYSE: PFE) has announced positive results from the Phase III TALAPRO-2 study for its oral poly ADP ribose polymerase (PARP) inhibitor, Talzenna (talazoparib). The study evaluated the drug in combination with Xtandi (enzalutamide) for the treatment of metastatic castration-resistant prostate cancer (mCRPC) with or without homologous…
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Hua Medicine’s Dorzagliatin Approved in China for Type 2 Diabetes
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China-based Hua Medicine (HKG: 2552) has announced that its Category 1 drug dorzagliatin has been approved by the National Medical Products Administration (NMPA) for improving blood glucose control in adults with type 2 diabetes. The first-in-class oral hypoglycemic drug represents an innovative treatment option for patients in China. Approval Based…
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Allergan Aesthetics Launches Juvederm Volite in China’s Boao Lecheng
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Allergan Aesthetics, an AbbVie company (NYSE: ABBV), has announced the commercial launch of Juvederm Volite at the Arsmo (Hainan) Aesthetic Hospital in Boao Lecheng, China. The product follows the successful introduction of Juvederm Volux into the region under the “first pilot, first trial” policy, further expanding the company’s aesthetic portfolio…
