-
Luye Pharma Partners with Nhwa and Fine Hin to Commercialize Toludesvenlafaxine
•
China-based Luye Pharma Group (HKG: 2186), Jiangsu Nhwa Pharmaceutical Co., Ltd (SHE: 002262), and Beijing Fine Hin Mobile Medical Technology Co., Ltd have agreed to leverage their respective expertise, platform advantages, and commercialization resources to bolster the commercialization of Luye’s Category 1 chemical drug toludesvenlafaxine (LY03005), an extended-release treatment for…
-
Pediatrix Therapeutics Licenses Tris Pharma’s ADHD Portfolio for Greater China
•
China-based Pediatrix Therapeutics announced a licensing agreement with US firm Tris Pharma, Inc., obtaining exclusive commercialization rights to the latter’s entire FDA-approved attention-deficit hyperactivity disorder (ADHD) portfolio, as well as pipeline products. The deal covers the territory of greater China, including mainland China, Hong Kong, Macau, and Taiwan. No financial…
-
Hainan’s New Regulations on Medical Devices in Boao Lecheng to Take Effect in 2023
•
The “Regulations on the Administration of Medical Devices in Boao Lecheng International Medical Tourism Pilot Zone, Hainan Free Trade Port,” approved by the Standing Committee of Hainan Provincial People’s Congress, is set to take effect as of January 1, 2023. The document is applicable to medical and health services, and…
-
Kintor’s KX-826 Reaches Primary Endpoint in Phase II Study for Female AGA
•
China-based Kintor Pharmaceutical Ltd (HKG: 9939) announced that the Phase II clinical study for its AR antagonist KX-826 (pyrilutamide) in female patients with androgenetic alopecia (AGA) in China has reached the primary endpoint. Study Design and ResultsThe randomized, double-blind, placebo-controlled, multicenter study, with 160 patients enrolled, is designed to assess…
-
Sansure Biotech’s Pertussis Detection Kit Approved by NMPA
•
China-based molecular diagnostics specialist Sansure Biotech Inc. (SHA: 688289) announced that it has obtained medical device approval from the National Medical Products Administration (NMPA) for its pertussis nucleic acid detection kit (PCR fluorescence probe method). Product and ApplicationThe product, used for the auxiliary diagnosis of patients with respiratory tract infection…
-
Simcere’s Edaravone, Borneol Sublingual Tablets Reach Phase III Efficacy Endpoint
•
Jiangsu Simcere Pharmaceutical Co., Ltd (HKG: 2096) announced that a Phase III clinical study for its edaravone, borneol sublingual tablets in acute ischemic stroke (AIS) has reached the pre-set efficacy endpoint. Preliminary analysis showed that, compared with a placebo, edaravone, borneol sublingual tablets could significantly improve the neurological recovery and…
-
AI Model for Early Alzheimer’s Detection Using Retinal Photographs Published
•
A joint Singapore-UK-Hong Kong research team has published details of an AI-based deep learning model that will help the early detection of Alzheimer’s disease using retinal photographs. The team trained a model by enrolling 648 people with Alzheimer’s and 3,240 without, taking over 12,000 retinal photographs. The model achieved an…
-
XJTLU and University of Liverpool Launch Joint Centre for Pharmacology and Therapeutics
•
The Suzhou-based Xi’an Jiaotong-Liverpool University (XJTLU) and the UK’s University of Liverpool earlier this month held the inauguration of the Joint Centre for Pharmacology and Therapeutics. The Joint Center will allow scientists from both countries to carry out research into disease mechanisms and develop novel drugs for currently relevant diseases.…
-
Yifan Pharmaceutical Licenses F-627 to Acrotech for US Distribution
•
China-based Yifan Pharmaceutical Co., Ltd (SHE: 002019) announced the establishment of a licensing agreement with US firm Acrotech Biopharma, Inc., granting the latter exclusive distribution rights to its efbemalenograstim alfa (F-627) in the United States. The drug is an in-house developed long-acting recombinant human granulocyte colony stimulating factor (rhGCSF)-Fc fusion…
-
Nans Tech Secures Series A Funding for Brain Dysfunction Digital Therapies
•
Nans Tech, a brain dysfunction digital therapy developer based in Hangzhou, reportedly raised “tens of million” of renminbi in a Series A financing round, solely led by Shulan Junjie Capital. Proceeds will go towards product industrialization and regulatory filing, technology and product research and development, and clinical promotion. Company Background…
-
Aclaris Therapeutics Licenses JAK Inhibitor ATI-1777 to Pediatrix for Greater China
•
US-based Aclaris Therapeutics Inc. (NASDAQ: ACRS) and Shanghai firm Pediatrix Therapeutics Inc. entered into a license agreement, with Pediatrix taking on development, manufacturing, and commercial rights in Greater China to Aclaris’s ATI-1777. ATI-1777 is a Janus kinase (JAK) 1/3 inhibitor, while Pediatrix is granted rights for any indication including atopic…
-
China’s NMPA Issues New GSP Appendix for Drug Retailing Quality Management
•
China’s National Medical Products Administration (NMPA) has released “Good Supply Practice (GSP) Appendix 6: Quality Management of Drug Retailing Delivery,” which will be effective from January 1, 2023. The new regulation aims to further standardize drug retailing delivery activities and ensure the quality and safety of drugs throughout the supply…
-
ImmuneOnco Initiates Phase II Clinical Study for CD47 Antibody IMM01
•
ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd has announced the initiation of a Phase II clinical study for its investigational drug IMM01, an antibody targeting the cluster of differentiation 47 protein (CD47), in combination with a programmed-death 1 (PD-1) inhibitor for the treatment of solid tumors and lymphomas. This marks a significant…
-
China’s NMPA Seeks Feedback on Drug Quality Management Provisions
•
China’s National Medical Products Administration (NMPA) has released a draft proposal titled “Provisions on the Supervision and Administration of Marketing Authorization Holder Implementing Drug Quality Subject Responsibilities,” and is soliciting public feedback until December 9. The document aims to enhance the quality management responsibilities of Marketing Authorization Holders (MAHs) in…
-
Luye Pharma’s Shandong Boan Bio Files for Hong Kong IPO
•
China-based Luye Pharma Group’s (HKG: 2186) controlling subsidiary, Shandong Boan Biotechnology Co., Ltd, has filed for an initial public offering (IPO) with the Hong Kong Stock Exchange. Key details of the IPO filing remain undisclosed at this stage. Company BackgroundFounded in 2013, Boan Bio has previously raised a total of…
-
Luca Healthcare Partners with Cambridge Cognition to Launch Cognitive Tools in China
•
China-based digital health solutions provider Luca Healthcare has announced a strategic partnership and license agreement with UK firm Cambridge Cognition. Under the agreement, Luca has secured a 10-year exclusive license to commercialize Cambridge Cognition’s suite of cognitive assessment tools in mainland China. Financial details of the agreement were not disclosed.…
-
Luye Pharma’s Biosimilar to Amgen’s Xgeva Launched in China
•
China-based Luye Pharma Group (HKG: 2186) has announced the first prescription of its biosimilar version of Amgen’s (NASDAQ: AMGN) Xgeva (denosumab), known as LY06006/BA6101, in Shandong, Jiangsu, Hunan, Tianjin, Shaanxi, and Jilin provinces. The drug was launched just 21 days after receiving marketing approval, marking a rapid entry into the…
-
Assure Tech Wins Japanese PDMA Approval for Pen-Type COVID-19 Antigen Test
•
China-based Assure Tech (Hangzhou) Co., Ltd (SHA: 688075) has announced receiving marketing approval from Japan’s Pharmaceuticals and Medical Devices Agency (PDMA) for its novel coronavirus antigen detection reagent (pen type). This approval marks a significant milestone for the company in expanding its presence in the global diagnostics market. Product DetailsThe…
-
Double-Crane Pharma Gains NMPA Approval for COVID-19 Drug CX2101A Clinical Trials
•
China Resources Double-Crane Pharmaceutical Co., Ltd (SHA: 600062) has announced receiving clinical trial approval from the National Medical Products Administration (NMPA) for its COVID-19 treatment candidate, CX2101A. This marks a significant step forward in the development of new therapeutic options for COVID-19 in China. CX2101A Technology and DevelopmentCX2101A is a…
-
Lepu Medical Wins NMPA Approval for Disposable Pressure Microcatheter
•
China-based cardiovascular disease solutions provider Lepu Medical Technology (Beijing) Co., Ltd (SHE: 300003) has announced receiving Category III device approval (No. 20223071559) from the National Medical Products Administration (NMPA) for its in-house developed disposable pressure microcatheter. This approval marks a significant milestone in the company’s efforts to enhance precision in…
