May 28, 2025
Source: drugdu
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Policy Tendence
The National Medical Products Administration issued a document requiring the implementation of the "Quality Management Standards for Medical Device Network Sales"
On May 26th, the National Medical Products Administration announced that the "Quality Management Standards for Online Sales of Medical Devices" (hereinafter referred to as the "Standards") will officially come into effect on October 1, 2025. Drug regulatory departments at all levels should guide online sales operators and e-commerce platform operators to actively carry out internal training and assessment, focusing on the comprehensiveness of the quality management system coverage of online sales operators, the standardization of product information display, the completeness of online sales related records, as well as the establishment of full process quality management records, verification and updating of network operator files, and the monitoring and risk consultation of medical device quality and safety risks within the platform. Enterprises should conduct key self inspections.
Medical device approval
BeiGene announces positive results in clinical trials of dual antibody new drug in China
On May 26th, BeiGene announced that its Phase 2 clinical trial DeLLphi-307 of tarlatamab for injection, jointly conducted with Amgen in China, has achieved positive results. The DeLLphi-307 (NCT06502977) study aims to evaluate the efficacy, safety, and tolerability of trastuzumab in the treatment of Chinese patients with extensive stage small cell lung cancer (ES-SCLC) who have previously failed at least second-line therapy, including platinum based chemotherapy. The primary endpoint of the study is the objective response rate (ORR). Detailed data will be announced at the upcoming medical conference.
Tongrentang Suhexiang Pills Obtained Canadian Product License
On May 26th, Tongrentang announced that its branch, Beijing Tongrentang Co., Ltd. Tongrentang Pharmaceutical Factory, has received a "Product License (Class III)" approved and issued by the Canadian Department of Health. Tongrentang Pharmaceutical Factory's product, Suhexiang Pill, has been registered as a Canadian product.
capital market
Boyin Biotech completes tens of millions of yuan angel+round financing
Recently, Shanghai Boyin Biotechnology Co., Ltd. completed tens of millions of yuan in angel+round financing. This round of investment is led by Zhangjiang Life and Health Industry Incubation Angel Fund, with long-term shareholders Fengrui Capital and the founder continuing to increase investment. Kaicheng Capital serves as the exclusive financial advisor for this round, and the funds raised will mainly be used for the promotion of the company's product pipeline and early clinical validation of the first product.
Industry Events
Yuheng Pharmaceutical and Xinghe Pharmaceutical signed a promotion agreement for Pemabet tablets
On May 26th, Yuheng Pharmaceutical announced that the company signed a joint promotion agreement with Xinghe Pharmaceutical Co., Ltd. on May 23rd, 2025 for Pemabet tablets. The agreement will come into effect on June 1, 2025, with an initial term until December 31, 2027, and can be automatically renewed thereafter. According to the agreement, Xinghe Pharmaceutical authorizes Yuheng Pharmaceutical to promote Pemabert tablets in designated areas and pay service fees and promotion support fees. Pemabet tablets are the world's first novel highly selective PPAR alpha modulator, primarily used to reduce triglyceride levels in adult patients with non familial hypertriglyceridemia.
Comment 21: Yuheng Pharmaceutical and Xinghe Pharmaceutical have reached a promotion agreement for the world's first PPAR alpha modulator Pemabet tablets, which is another typical case of domestic pharmaceutical companies undertaking the commercialization promotion of innovative drugs. For Yuheng Pharmaceutical, obtaining the promotion rights for the world's first new highly selective PPAR α regulator enriches the product pipeline and is expected to bring new profit growth points. However, challenges cannot be ignored. As a pioneering new drug, Pemabet tablets face market competition from mature products such as statins, and the progress of medical insurance admission will directly affect the speed of mass production.
Public opinion warning
Wang Baocai, Vice President of Step Pharmaceuticals, Resigns
On May 26th, Changbu Pharmaceutical announced that on May 26th, 2025, the company's board of directors received a written resignation report from Vice President Wang Baocai. Due to personal reasons, he applied to resign from the position of Vice President of the company and will not hold any position in the company after resignation. Wang Baocai currently holds relevant positions in a subsidiary of the company, and the company will promptly fulfill the relevant procedures and handle the business registration change procedures. Wang Baocai's resignation report shall take effect from the date of delivery to the board of directors.
Chengdu's leading shareholder reduces holdings by 1 million shares
On May 26th, Chengdu Pioneer announced that shareholder Anji Dongfang Jiayu Enterprise Management Partnership (Limited Partnership) will reduce its stake in the company by 1 million shares on May 23rd, 2025. The equity change has reached the 1% mark, resulting in a decrease in its shareholding ratio from 6.2% to 5.95%.
BioVeda, a shareholder of Aojing Medical, reduces its stake in the company by 0.25%
On May 26th, Aojing Medical announced that shareholder BioVeda China RMB Investment Limited plans to reduce its stake in the company by no more than 1.3555 million shares, accounting for 1% of the company's total shares, through centralized bidding and bulk trading. As of May 25, 2025, BioVeda China RMB Investment Limited has reduced its holdings of 345100 shares in the company, accounting for 0.25% of the total share capital.
Warner Pharmaceutical Company's second instance lawsuit settled through mediation
On May 26th, Warner Bros. Pharmaceutical announced that it had recently received a "Civil Mediation Agreement" served by the Supreme People's Court, and the lawsuit has been settled through mediation. Warner Pharmaceutical and Dalian CITIC are required to pay compensation of 7.9 million yuan to Nanjing Shenghe in two installments; The acceptance fee for the second instance of the two cases is 96100 yuan, and Warner Pharmaceutical will bear 48100 yuan. Warner Pharmaceuticals stated that this mediation has a relatively small impact on the company's profits for the current period, and the company's business operations are currently normal.
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