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健讯Daily | 乐普医疗“童颜针”获得NMPA注册批准;华熙生物回应近期风波
2 1 Shi Ji Jing Ji Bao Dao· 2025-06-03 23:44
Policy Developments - The State Administration for Market Regulation announced ten typical cases of illegal advertising, with multiple cases involving the medical field, including one case related to medical device advertising and two cases concerning illegal drug advertising [2] - As of the end of April, a total of 11,459 illegal advertising cases were investigated, resulting in fines totaling 88.309 million yuan [2] Drug and Device Approvals - Shuyou Shen announced that its subsidiary received a notice from the National Medical Products Administration regarding the conditional listing application for "STSP-0601," a drug aimed at promoting rapid hemostasis for adult patients with hemophilia A or B [4] - Lepu Medical received registration approval from the NMPA for its self-developed polylactic acid facial filler, known as "童颜针," marking a significant milestone in the dermatology field [5] Capital Market Activities - Baiyang Pharmaceutical announced the release of 5.3 million shares from pledge by its controlling shareholder, representing 1.44% of the shares held by the shareholder and 1.01% of the company's total share capital [7] - Jincheng Pharmaceutical provided a guarantee of 5 million yuan for its wholly-owned subsidiary, Shandong Jincheng Biological Pharmaceutical Co., Ltd. [8] Industry Developments - AstraZeneca announced significant progress in the treatment of EGFR mutation-positive non-small cell lung cancer with MET amplification, with interim results from the SACHI Phase III study to be presented at the ASCO annual meeting [10][11] - Yuheng Pharmaceutical signed a market promotion service agreement with Eisai (China) Pharmaceutical for "Mikobao," which will enhance Yuheng's product pipeline and increase revenue [12] - New Scene Intelligence authorized BeiGene to develop universal cell therapy drugs based on a specific TCR molecule, with potential milestone payments and revenue sharing [13] - Buchang Pharmaceutical withdrew its clinical trial application for a rabies vaccine, indicating the need for further research before resubmission [14] Public Opinion Alerts - Huaxi Biological responded to recent controversies regarding recombinant collagen, emphasizing the importance of product quality over naming conventions [16] - Kangning Jerey announced a share transfer agreement involving 14.6 million shares, amounting to 117 million HKD [17]