Policy Developments - The National Healthcare Security Administration (NHSA) released the 11th batch of national drug centralized procurement documents, emphasizing principles of "stabilizing clinical use, ensuring quality, preventing collusion, and countering internal competition" [2] - The new procurement strategy optimizes "anchor prices" by not simply selecting the lowest bid but using the higher value between the average of "comparable unit prices" and the lowest "comparable unit price" at 50% [2] Drug and Device Approvals - Fosun Pharma announced that its subsidiary, Fuhong Hanlin, received EU approval for two drugs, BILDYOS® and BILPREVDA®, for treating osteoporosis in high-risk patients [4] - Renfu Pharma's subsidiary received a tentative FDA approval for Oxcarbazepine extended-release tablets, aimed at treating partial seizures in patients aged 6 and above, with a total R&D investment of approximately 15 million RMB [5] Capital Markets - LuKang Pharmaceutical plans to acquire a 1.9231% stake in Shandong Lukang Hecheng Pharmaceutical Co., with the final amount to be determined through bidding [7] - GE Healthcare responded to rumors about selling its Chinese business, stating its commitment to providing high-quality medical services in China [8] Industry Events - The NHSA announced the interim results of expert reviews for the 2025 National Basic Medical Insurance Directory and commercial insurance innovative drug directory adjustments [10][11] - In the first half of 2025, China's innovative drug licensing transactions reached nearly $66 billion, indicating a significant increase in international recognition and commercial value of Chinese innovative drugs [12] - The National Medical Products Administration established a review center in the Beijing-Tianjin-Hebei region to enhance drug and medical device evaluation services [13] - Approximately 100 rare disease drugs have been included in the basic medical insurance directory, covering 42 types of rare diseases [14]

Core Points - The company announced that its subsidiary, Wuhan Renfulikang Pharmaceutical Co., Ltd., received a tentative approval from the FDA for Oxcarbazepine Extended-Release Tablets [1][2] - The product is intended for the treatment of partial seizures in patients aged 6 and above [1] - The ANDA application was submitted in 2024, with a total R&D investment of approximately 15 million RMB [1] - The total sales for Oxcarbazepine Extended-Release Tablets in the U.S. market is estimated to be around $216 million in 2024 [1] Regulatory and Market Context - The ANDA approval is tentative due to the original drug "OXTELLAR XR" being under patent protection until April 13, 2027 [2] - The product must receive final FDA approval after the patent expires before it can be marketed in the U.S. [2] - Other companies, including APOTEX and AJANTA PHARMA LTD, have received formal approvals, while several others have tentative approvals [1][2]

Core Viewpoint - The company announced that its subsidiary, Wuhan Renfulikang Pharmaceutical Co., Ltd., received a tentative approval number from the U.S. Food and Drug Administration (FDA) for Oxcarbazepine extended-release tablets [1] Group 1 - The company holds a 75.33% stake in Wuhan Renfulikang, with plans to acquire 100% ownership based on a future repurchase agreement [1] - The FDA's tentative approval is a significant milestone for the company, potentially enhancing its product portfolio in the U.S. market [1]

Core Viewpoint - The company, Renfu Pharmaceutical, announced that its subsidiary, Wuhan Renfu Likang Pharmaceutical Co., Ltd., received a tentative approval number from the U.S. Food and Drug Administration (FDA) for Oxcarbazepine extended-release tablets, which are intended for the treatment of partial seizures in patients aged 6 and older [1]. Company Summary - Renfu Pharmaceutical holds a 75.33% stake in Wuhan Renfu Likang, with plans to acquire 100% equity based on a future repurchase agreement [1]. - The approved product, Oxcarbazepine extended-release tablets, targets a specific patient demographic, indicating a focused approach in the company's product development strategy [1].

Core Viewpoint - The company, Renfu Pharmaceutical, announced that its subsidiary, Wuhan Renfu Likang Pharmaceutical Co., Ltd., received a tentative approval number from the U.S. Food and Drug Administration (FDA) for Oxcarbazepine extended-release tablets, which are used to treat partial seizures in patients aged 6 years and older [1]. Group 1 - The FDA's tentative approval indicates a significant milestone for the company in expanding its product offerings in the U.S. market [1]. - Oxcarbazepine extended-release tablets are specifically indicated for the treatment of partial seizures, highlighting the company's focus on addressing neurological conditions [1].

Core Viewpoint - The announcement indicates that Renfu Pharmaceutical's subsidiary, Renfu Likang Pharmaceutical Co., Ltd., has received a tentative approval number from the FDA for Oxcarbazepine extended-release tablets, which are intended for the treatment of partial seizures in patients aged 6 and above [1] Group 1: Product Development - Renfu Likang has invested approximately 15 million RMB in the research and development of Oxcarbazepine extended-release tablets [1] - The total sales revenue for Oxcarbazepine extended-release tablets in the U.S. market is projected to be around 216 million USD in 2024 [1] Group 2: Patent and Market Entry - Supernus currently holds the patent for Oxcarbazepine extended-release tablets, which is set to expire on April 13, 2027 [1] - Renfu Likang can only launch the product in the U.S. market after the patent expiration and the final approval from the FDA [1]

Group 1 - The company, Renfu Pharmaceutical, announced that its subsidiary, Wuhan Renfulikang Pharmaceutical Co., Ltd., received a tentative approval number from the U.S. Food and Drug Administration (FDA) for Oxcarbazepine extended-release tablets [1] - The Oxcarbazepine extended-release tablets are indicated for the treatment of partial seizures in patients aged 6 years and older [1]

Group 1 - The core point of the article is that Renfu Pharmaceutical has received a tentative approval number from the US FDA for its drug Oxycarbazepine extended-release tablets, which are intended for the treatment of partial seizures in patients aged 6 and older [2] - The company has invested approximately 15 million RMB in the research and development of this drug [2] - Several manufacturers, in addition to the original manufacturer Supernus, have received either formal or tentative approval numbers for this product [2] Group 2 - The product can only be marketed in the US after the original drug's patent expires and the FDA grants final approval [2] - The company has issued a reminder to investors to be aware of investment risks associated with this development [2]