On October 13, 2023, China News Service reported from Beijing on several significant developments in the healthcare sector from October 7 to October 13. These updates are noteworthy for readers interested in recent trends and policies aimed at improving patient care and collaboration within the industry.
**Key Industry News**
On October 9, the National Health Commission (NHC) of China released a notification on its website about the “Action Plan for Enhancing Medical Humanistic Care (2024-2027).” This initiative aims to meet the growing demand for high-quality medical services from the public. The plan is centered around improving patient experiences and satisfaction through principles of mutual respect, privacy protection, strict adherence to laws, and enhanced communication. The emphasis is on a patient-centered approach that promotes medical education and fosters trustful doctor-patient relationships.
Meanwhile, the State Administration for Market Regulation (SAMR) has drafted the “Compliance Guidelines for Pharmaceutical Enterprises to Prevent Commercial Bribery Risks,” currently open for public feedback until October 20, 2024. This draft consists of four chapters with 49 articles, detailing compliance management systems, risk identification and prevention, and risk resolution related to commercial bribery in the pharmaceutical sector.
Additionally, on October 11, the National Medical Products Administration (NMPA) announced a new notification regarding the re-registration procedures and documentation requirements for domestically produced pharmaceuticals. This aims to standardize the re-registration review and approval criteria across provincial drug supervision departments, streamlining procedures and alleviating the burden on companies.
**Company Highlights**
On October 7, AstraZeneca and China-based Stone Group reached an exclusive licensing agreement to develop an innovative lipoprotein(a) inhibitor, advancing clinical research in lipid-lowering therapies. This collaboration will allow AstraZeneca to utilize Stone’s clinical candidate drug, YS2302018, for treating various cardiovascular conditions.
On October 11, Kanghui Pharmaceuticals reported the completion of a share transfer, with the shareholder TBP Traditional Medicine Investment Holdings (H.K.) Limited selling 9.988 million unrestricted shares, representing 10% of the company’s total shares, to Shanghai Selexen Enterprise Management Consulting Co., Ltd. at a price of 11.08 yuan per share, totaling 110 million yuan.
In legal news, China National Pharmaceutical Group announced a lawsuit against Tibet Tiancheng Taifeng Pharmaceutical Co., Ltd. and Xu Panfeng, regarding a performance compensation contract dispute involving over 139 million yuan.
**Drug and Device Approvals**
On October 8, the NMPA approved two products from Yaoyou Group, confirming their equivalence in quality and efficacy with existing generics: sodium pravastatin tablets (10mg) and fluvoxamine maleate tablets (50mg) from Hunan Dongting Pharmaceutical.
On October 10, Heng Rui Medicine received approval from the U.S. FDA for its injectable paclitaxel (albumin-bound), marking the first approval of this generic drug in the U.S. market. The product had already been launched domestically in 2018 for treating specific types of breast cancer.
Eli Lilly announced on October 11 plans to invest approximately 1.5 billion RMB to enhance production capacity at its Suzhou facility, aiming to boost the manufacturing scale of the innovative diabetes and obesity treatment tirzepatide. This investment represents one of the largest global capacity upgrades in the company’s history.
**Public Opinion Alert**
On October 11, East China Pharmaceutical’s subsidiary, Yianshi, publicly announced a lawsuit against Shandong Caicai Medical and its parent company for allegedly infringing on its patent rights concerning a specific injectable polylactic acid microsphere filler product, which has been accepted for litigation by the Shanghai Intellectual Property Court.
Lastly, on October 12, it was reported that Sima Biological, once a leading company in the mRNA vaccine space, has entered bankruptcy proceedings. The former CEO, Shen Haifa, expressed his commitment to assisting in the management of the situation and maintaining hope for the company’s resurgence. The company’s founder, Li Hangwen, has not yet commented on these developments.
