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China’s Beijing Aosaikang Pharmaceutical Co., Ltd (SHE: 002755) has revealed that a market filing for its generic version of Japan-based Takeda’s (TYO: 4502) Livtencity (maribavir) has been accepted for review by the National Medical Products Administration (NMPA). This marks a significant step in the potential introduction of a more accessible…
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China-based Contract Manufacturing Organization (CMO) Sinobioway Medicine (SHE: 002581) has announced a clinical trial technical service agreement with compatriot firm Happy Life Tech (HLT), an affiliate of Yidu Tech (HKG: 2158). The agreement focuses on recombinant human nerve growth factor eye drops, targeting moderate to severe dry eye conditions. Phase…
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China’s Beijing Balance Medical Technology Co., Ltd. (SHA: 688198) has announced that it has received fast-track designation from the Center for Medical Device Evaluation, NMPA, for its in-house developed all-comer interventional pulmonary valve and delivery system. This marks the third interventional valve product from Balance Medtech to receive fast-track status…
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Sino-US firm MicuRx Pharmaceuticals Inc. (SHA: 688373) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its drug MRX-5. The study will focus on infections caused by non-tuberculous Mycobacteria (NTM) that are sensitive to this product. MRX-5: A Promising…
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China-based Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521) has announced that it has received clearance from the National Medical Products Administration (NMPA) for its investigational drugs HB0028 and HB002.1T. The drugs are set to enter clinical studies, either in combination with or without standard chemotherapy, for the treatment of advanced…
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its investigational drug HRS-6768. This approval allows the company to proceed with testing the drug in patients with advanced solid tumors. Innovative Radiation Therapy for…
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Milestone Biotechnologies, a leading biotechnology company based in Shanghai, has announced the completion of a nearly 100 million yuan Series A+ funding round. The round was led by Xingzheng Capital, with participation from Ji Gao Financial Company and Nanjing Innovation Investment Group. Kaideng Capital continued to serve as the exclusive…
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UK-based AstraZeneca (AZ, NASDAQ: AZN) has announced that it has received a new indication approval from China’s National Medical Products Administration (NMPA) for its non-small cell lung cancer (NSCLC) treatment, Tagrisso (osimertinib). This approval is for the use of Tagrisso in treating adult patients with locally advanced, unresectable NSCLC, whose…
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The National Medical Products Administration (NMPA) in China has granted AstraZeneca (AZ, NASDAQ: AZN) and Merck, Sharp & Dohme (MSD; NYSE: MRK) a regulatory nod for their drug Lynparza (olaparib). The approval is for adjuvant treatment in adult patients with early high-risk breast cancer who have undergone neoadjuvant or adjuvant…
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US-based pharmaceutical company Gilead Sciences Inc., (NASDAQ: GILD), has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its drug Sunlenca (lenacapavir). The drug is approved for use in combination with antiretroviral drugs for adult patients with multidrug-resistant human immunodeficiency virus type 1 (HIV-1)…
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China-based Hong Kong WinHealth Pharma Group has announced that the National Medical Products Administration (NMPA) has accepted its market approval filing for review for difelikefalin. WinHealth holds exclusive development and commercialization rights to the Category 5.1 drug in China, following a licensing deal secured with Vifor Fresenius Medical Care Renal…
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Shanghai-based Thederma has announced that its drug candidate TAN-118 has obtained tacit clinical approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China. This follows the clearance received from the US FDA in October of the previous year, indicating that TAN-118, an AhR…
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China-based Shenzhen Hepalink Pharmaceutical Group Co., Ltd (SHE: 002399, HKG: 9989) has announced a product distribution agreement with Zhejiang Yongtai Technology Co., Ltd. The agreement, for which no financial details have been disclosed, appoints Hepalink as the entity responsible for the marketing, promotion, and commercialization of Yongtai’s gabapentin in the…
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China-based Innovent Biologics, Inc. (HKG: 1801) has announced receiving an additional marketing approval from the National Medical Products Administration (NMPA) for its drug taletrectinib. This second-generation ROS1 tyrosine kinase inhibitor is now approved for use in treating adult patients with ROS1 positive locally advanced or metastatic non-small cell lung cancer…
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Taizhou-based monoclonal antibody (mAb) biosimilar specialist MabPharm Ltd (HKG: 2181) has announced the receipt of market approval for CMAB807, a biosimilar version of Johnson & Johnson (J&J, NYSE: JNJ)’s Remicade (infliximab), in Pakistan. This follows similar approvals in Peru and Indonesia last year. The approval encompasses all six indications, which…
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China-based Lee’s Pharmaceutical Holdings Ltd’s (HKG: 0950) former subsidiary, Zhaoke Ophthalmology Ltd (HKG: 6622), has announced that the National Medical Products Administration (NMPA) has accepted for review the Abbreviated New Drug Application (ANDA) for NVK002, an atropine external use eye solution aimed at pediatric myopia progression. NVK002: A Novel Ophthalmic…
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China-based Grand Pharmaceutical Group Co., Ltd. (HKG: 0512) has announced the first patient enrollment in a regulatory study designed to assess the safety and efficacy of GPN00289. This innovative temperature sensitive embolic product is intended for use in arterial chemoembolization of primary liver cancer. GPN00289: An Innovative Medical Device for…
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SCG Cell Therapy Pte. Ltd, a Singapore-based company with a presence in Shanghai, has received clinical trial approval from the National Medical Products Administration (NMPA) for its innovative therapy, SCG142. This human papillomavirus (HPV) specific T cell receptor (TCR) therapy is set to be tested in a range of HPV-related…
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Huadong Medicine Co., Ltd (SHE: 000963) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its investigational drug HDM1005. This long-acting agonist targets both the GLP-1 receptor and GIP receptor and will be tested in metabolic associated fatty liver disease (MAFLD) and…
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Cygenta, a cell and gene therapy (CGT) focused Contract Development and Manufacturing Organization (CDMO) based in Beijing, has announced a strategic partnership with Russia-based IZVARINO Pharma Limited Liability Company. The collaboration aims to enhance the development and manufacturing capabilities for both companies, with a focus on advancing therapies in the…