The first precision treatment drug for ALS has been launched; Chen Shoujun, a core technical personnel of Huiyu Pharmaceutical, has resigned from the company. Health News Daily

June 12, 2025  Source: drugdu 65

 

Policy Tendence

National Health Commission: Promote the construction of compact urban medical groups in 81 pilot cities across the country

On June 10th, the relevant person in charge of the National Health Commission stated that in accordance with the overall requirement of "major illnesses should not leave the province, general illnesses should be solved in cities and counties, and daily illnesses should be solved at the grassroots level", firstly, the construction of national medical centers and national regional medical centers should be promoted, which is commonly referred to as the "dual center" construction. Secondly, we should focus on the construction of urban medical groups. Promote the construction of compact urban medical groups in 81 pilot cities across the country, and promote the sharing of medical resources.

In addition, by the end of 2024, 2188 counties (cities, districts) across the country have promoted the construction of close county-level medical communities, achieving comprehensive coverage at the provincial level. By 2024, the county-level resource sharing centers for imaging, electrocardiography, and laboratory testing, as well as the central pharmacies, will provide nearly 190 million services, allowing more people to enjoy the convenience of "grassroots examinations, higher-level diagnoses, and mutual recognition of results".

Comment 21: Both the construction of closely integrated urban medical groups and closely integrated county-level medical communities emphasize the "sharing" of resources. Recently, the General Office of the Central Committee of the Communist Party of China and the General Office of the State Council issued the "Opinions on Further Ensuring and Improving People's Livelihood and Focusing on Solving the Urgent, Difficult and Anxious Needs of the Masses", emphasizing the promotion of "sharing high-quality medical and health resources" to maximize the benefits of limited resources. With the continuous promotion of medical groups and medical communities, high-quality medical resources will benefit more people.

Medical device approval

Mike Biology obtains product registration certificate

On June 10th, Mike Bio (300463.SZ) announced that the company has recently received four "Medical Device Registration Certificates" issued by the Sichuan Provincial Drug Administration, including the Anticardiolipin Antibody Test Kit (Direct Chemiluminescence Method), which is mainly used for the auxiliary diagnosis of antiphospholipid syndrome and systemic lupus erythematosus. These products are new reagent products for the company's direct chemiluminescence platform, which will enrich the company's product menu, enhance market competitiveness, and have a positive impact on market expansion and future operations.

New industry obtains 1 medical device registration certificate

On June 10th, New Industry (300832. SZ) announced that it has recently received a "Medical Device Registration Certificate" issued by the Guangdong Provincial Drug Administration. The product name is fully automatic chemiluminescence immunoassay analyzer (model: MAGLUMI X10), registered as Class II, and valid until June 9th, 2030. This product adopts a direct chemiluminescence method based on isoluminol derivatives and is used in conjunction with supporting detection reagents for qualitative or quantitative detection of analytes in serum, plasma, urine, and whole blood samples from the human body in clinical practice.

New Novartis: The holding subsidiary SYS6040 antibody conjugate drug has been approved for clinical use in the United States

On June 10th, Novo Nordisk (300765. SZ) announced that its subsidiary, Jushi Biotechnology, has received FDA notification that the clinical trial application for the injection drug SYS6040 has been approved and can be conducted in the United States. SYS6040 is a monoclonal antibody conjugate drug, and the clinical indication approved this time is advanced solid tumors. Previously, the drug had obtained approval from the China National Medical Products Administration to conduct clinical trials in China.

capital market

Sinopharm plans to transfer 100% equity of its wholly-owned subsidiary Tong'an Pharmaceutical for 15 million yuan

On June 10th, Sinopharm (688136. SH) announced that the company plans to transfer 100% equity of its wholly-owned subsidiary Shenzhen Tong'an Pharmaceutical Co., Ltd. to Guangxi Zhuang Autonomous Region Institute of Materia Medica Co., Ltd. for a transfer price of 15 million yuan. This transaction does not constitute a related party transaction, nor does it constitute a significant asset restructuring. Tong'an Pharmaceutical has not actually conducted business in recent years. After the transaction is completed, the company no longer holds equity in Tong'an Pharmaceutical, and Tong'an Pharmaceutical is no longer included in the company's consolidated financial statements. This transaction is beneficial for the company to continue focusing on the biopharmaceutical field, enhance its core competitiveness, and reduce operational risks. It is expected to increase the company's total profit and cash flow in 2025.

Zhongsheng Pharmaceutical: There is uncertainty in the clinical trial progress of the investigational product RAY1225 injection

On June 10th, Zhongsheng Pharmaceutical (002317. SZ) announced that the company's stock had deviated from the daily closing price by more than 20% for two consecutive trading days on June 9th and June 10th, 2025, which constitutes abnormal fluctuations in stock trading. At present, the Phase III clinical trial of RAY1225 injection in the treatment of overweight/obese patients and two Phase III clinical trials for patients with type 2 diabetes have obtained the ethical approval for clinical trials. The clinical trial progress, review and approval results, and future market competition pattern of RAY1225 injection all have certain uncertainties. There is uncertainty regarding whether a drug can be approved for marketing, as well as the timing of approval and the production and sales situation after marketing.

Zhonghui Pharmaceutical has completed two rounds of financing worth tens of millions of yuan

Recently, Shaanxi Yungu Zhonghui Biopharmaceutical Co., Ltd. completed nearly 50 million yuan in seed and angel round financing. The seed round financing was jointly invested by Xincheng Investment and Aikang Chuangtan, while the angel round financing was jointly invested by Shaanxi Investment Growth Fund, Zhongke Chuangxing, and Jinzi Fund. The new round of financing will be used for the construction of China's first hollow microneedle medical device production base, the application for Class III device certificates, the construction of cell and extracellular vesicle pilot workshops, the construction of the first automated biological tissue sample bank in Northwest China, and the improvement of the talent team. In addition, Zhonghui Pharmaceutical announced the completion of the merger and reorganization of Shanghai Lanwei Medical Technology Co., Ltd.

Industry Events

The world's first precision treatment drug for ALS, Kaishengdi, has been commercially launched in China

On June 10th, Bojian China announced that the innovative drug Tovsheng Injection (trade name: Kaishengdi) has officially been commercially launched in China, which means that eligible ALS patients in China will soon have the opportunity to use this innovative drug. On the day of its launch, Tovsheng Injection was prescribed locally at Peking University Third Hospital and Hangzhou First People's Hospital affiliated with Xihu University School of Medicine, and the first batch of patients have benefited from it.

China National Pharmaceutical Group plans to acquire Pailin Biotechnology

On June 10th, Pailin Biotechnology announced that its controlling shareholder, Shengbang Yinghao, has signed an acquisition framework agreement with China Biology. China Biology plans to acquire 21.03% of Pailin Biotechnology's shares held by Shengbang Yinghao. If the transaction is successfully completed, the controlling shareholder of Pailin Biotechnology will be changed to China Biology, and the actual controller will also be changed from Shaanxi Provincial State owned Assets Supervision and Administration Commission to China National Pharmaceutical Group.

Comment 21: Starting from May 2001, China no longer approves new blood product production enterprises. Currently, there are less than 30 blood product production enterprises operating normally in China, and a few enterprises have multiple production licenses. Data shows that by 2024, the market size of blood products in China will reach 60 billion yuan. Nowadays, the competition in this market is intensifying, and the pattern of the blood products industry is further tilting towards large enterprises, accelerating industry integration.

Public opinion warning

Chen Shoujun, a core technical personnel of Huiyu Pharmaceutical, has resigned

On June 10th, Huiyu Pharmaceutical announced that its core technical personnel, Chen Shoujun, recently applied to resign from his position at the company due to personal reasons and has completed the resignation procedures. Chen Shoujun will no longer hold any position in the company after his resignation. Huiyu Pharmaceutical pointed out that during his tenure, Chen Shoujun was mainly responsible for the company's research and development of innovative small molecule chemical drugs. At present, the handover of work with the company's R&D team has been completed, and their departure will not have a negative impact on the company's technology research and development, product innovation, core competitiveness, and sustainable business capabilities.

By editor
Share: 

your submission has already been received.

OK

Subscribe

Please enter a valid Email address!

Submit

The most relevant industry news & insight will be sent to you every two weeks.