July 25, 2025
Source: drugdu
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National Medical Products Administration: Currently, China's R&D pipeline for innovative drugs accounts for about 1/4 of the global total
On July 23rd, according to statistics from the National Medical Products Administration, China approved 43 innovative drugs in the first half of the year, a year-on-year increase of 59%, approaching the annual number of approved innovative drugs of 48 in 2024. Yang Ting, Director of the Drug Registration Management Department of the National Medical Products Administration, stated that in terms of research and development pipelines, China currently accounts for about 1/4 of the world's innovative drug research and development pipelines. In terms of clinical trials, we have about 3000 projects undergoing clinical trials every year, which ranks among the top in the world. It is reported that the National Medical Products Administration will focus on increasing policy supply, guiding and encouraging enterprises to carry out innovative drug research and development guided by clinical value in the next step. Yang Ting told reporters that the National Medical Products Administration will also improve the drug review and approval procedures and rules, enhance the quality and efficiency of research and development, and encourage innovation in the development of multi link vaccines, cell and gene therapy products.
The National Healthcare Security Administration announces the list of pilot areas and units for intelligent supervision reform
On July 23, the National Healthcare Security Administration issued a notice, in accordance with the work arrangement of the "Notice of the Office of the National Healthcare Security Administration on Carrying out the Pilot of Intelligent Supervision Reform" (Medical Insurance Office Letter [2025] No. 40), 92 pilot areas (including Tianjin, Hebei, Shandong, Hainan, Guizhou, Qinghai, and Ningxia as provincial pilot areas) and 359 pilot designated medical institutions have been determined through voluntary registration by designated medical institutions, selection by provincial medical insurance bureaus, and screening by the National Healthcare Security Administration (the list is attached). Provincial medical insurance bureaus should make good use of the intelligent supervision "two databases" rules and their knowledge points publicly released by the National Medical Insurance Bureau in batches, and carry out pilot work on intelligent supervision reform. On the one hand, we will promote the implementation and application of intelligent supervision "two databases" in the self built pre warning system of designated medical institutions, and build pilot designated medical institutions into "experimental fields" for the development, construction, and public disclosure of "two databases" by the National Medical Insurance Bureau, as well as "benchmarks" for self-examination and self correction. On the other hand, we will promote the improvement of the application effectiveness of the intelligent supervision subsystem in the whole province, move the regulatory checkpoint forward, reduce the occurrence of illegal and irregular use of medical insurance funds from the source, and make the "two databases" public and intelligent supervision an effective way for designated medical institutions to actively comply.
Medical device approval
Huadong Pharmaceutical's injection of Cabozantine Acetate has been approved by the US FDA
On July 23rd, Huadong Pharmaceutical (000963. SZ) announced that its wholly-owned subsidiary, Zhongmei Huadong, has received a notification from the US FDA that its application for the abbreviated new drug application (ANDA) for injectable caspofungin acetate has been approved. The generic name of this drug is Cabozantine Acetate for Injection, and the dosage form is an injection with specifications of 50mg and 70mg. This is another product approved by the US FDA, following pantoprazole sodium for injection, acarbose tablets, daptomycin for injection, tacrolimus capsules, and fondaparinux sodium injection, in line with the company's strategic plan of "internationalization of formulations". As of now, the company's direct investment in this project is approximately 36.2 million RMB.
Haizheng Pharmaceutical's raw material for bedaquiline fumarate has been approved for market launch
On July 23rd, Haizheng Pharmaceutical (600267. SH) announced that the company has received the "Notice of Approval for Chemical Raw Material Marketing Application" for the raw material of bedaquiline fumarate approved and issued by the National Medical Products Administration. This drug is suitable for the treatment of multidrug-resistant tuberculosis (MDR-TB) in adults and adolescents. The original manufacturer is Xi'an Yangsen Pharmaceutical. Haizheng Pharmaceutical is one of the major domestic manufacturers and has invested approximately RMB 14.422 million in the research and development of this drug.
Financial report disclosure
Dirui Medical expects a net loss of 22-33 million yuan in the first half of the year
On July 22, Dirui Medical announced that it expects a net profit loss of RMB 22-33 million attributable to shareholders of the listed company in the first half of 2025, compared to a profit of RMB 165 million in the same period last year. The reason for the performance change is the overall decline in the company's gross profit, the lower than expected installation of instrument products and reagents in the domestic market, resulting in a significant decrease in the company's net profit level, and based on the principle of prudence, the company has made corresponding provisions for impairment of assets with signs of impairment.
Yao Ming United expects its adjusted net profit to increase by over 67% in the medium term
On July 23rd, WuXi AppTec announced that it expects its revenue to increase by over 60% year-on-year in the first half of 2025, its adjusted net profit (excluding interest income and expenses) to increase by over 67% year-on-year, and its net profit to increase by over 50% year-on-year. The company believes that the expected growth is mainly attributed to the sustained strong downstream demand for antibody conjugated drugs (ADCs) and the broader bio conjugated drug industry; The group has gained significant market share in the bio coupled drug CRDMO through a solid leading position and competitive advantage; The production capacity of the new production line of the group has rapidly increased, and the production facilities continue to maintain high utilization and operational efficiency.
capital market
Mindray Medical responds to its second IPO in Hong Kong
On July 23rd, there were market reports that medical device manufacturer Mindray Medical is considering a second listing in Hong Kong, with an expected fundraising of at least $1 billion. On the same day, Mindray Medical responded to the media, stating that official information should prevail.
US healthcare group CHS reaches agreement with Labcorp
On July 23, CHS (Community Health Systems), one of the largest healthcare groups in the United States, announced that its subsidiary has reached a final agreement with Labcorp, a comprehensive laboratory service provider. Labcorp will acquire specific non inpatient laboratory service assets of CHS Healthcare Systems in 13 states for $195 million in cash, including some patient service centers and on-site blood collection stations. CHS stated that the transaction is subject to standard delivery conditions and regulatory approval, and is expected to be completed in the fourth quarter of 2025.
Industry Events
State Administration for Market Regulation: Ban on Wuhan Yongtong's acquisition of equity in Shandong Huatai Pharmaceutical
On July 23rd, the State Administration for Market Regulation issued a notice on the anti-monopoly review decision to prohibit Wuhan Yongtong Pharmaceutical Co., Ltd. from acquiring the equity of Shandong Beida Gaoke Huatai Pharmaceutical Co., Ltd. After evaluation, the State Administration for Market Regulation believes that the solution submitted by the applicant indicates its willingness to take measures to restore the pre concentration state. Considering that the concentration of operators in the domestic market of Papaverine Hydrochloride Injection in China has the effect of excluding and restricting competition, and the declaring party is willing to take measures to restore the pre concentration state, the State Administration for Market Regulation has decided to prohibit this concentration and ordered Wuhan Yongtong and its ultimate controller to take the following measures:
(1) Before January 22, 2026, transfer its indirectly held shares in Shandong Huatai Pharmaceutical to unrelated third parties. If there are special circumstances that prevent the completion of equity transfer, one should apply to the State Administration for Market Regulation in advance and explain the reasons. If the buyer cannot be found within the prescribed period or the extended period agreed by the State Administration for Market Regulation, the divestment trustee should be entrusted to find a suitable buyer and complete the equity transfer. Before the completion of the equity transfer, no one shall participate in the operation and management of Shandong Huatai Pharmaceutical in any way.
(2) Before September 30, 2025, terminate the agency agreement for the raw material of Papaverine Hydrochloride with operators such as Qinghai Pharmaceutical, and do not execute the relevant agreement before termination.
(3) Timely report to the State Administration for Market Regulation on the transfer of equity and termination of the agency agreement for active pharmaceutical ingredients.
At the same time, the ultimate controller of Wuhan Yongtong voluntarily promised not to engage in business concentration in the field of papaverine hydrochloride raw materials and papaverine hydrochloride injections in the future.
The State Administration for Market Regulation has the right to supervise and inspect the performance of the above obligations by Wuhan Yongtong and its ultimate controller. If Wuhan Yongtong and its ultimate controller fail to fulfill or violate the above obligations, the State Administration for Market Regulation will take action in accordance with the relevant provisions of the Anti Monopoly Law of the People's Republic of China
Watson Biotech and Yuxi Operations Company signed a strategic cooperation framework agreement
On July 23, Watson Biotech (300142. SZ) announced that the company signed a "Strategic Cooperation Framework Agreement" with Yuxi State owned Capital Operation Co., Ltd. on July 22, 2025. The two parties plan to establish a long-term cooperative relationship in the field of vaccines and biological products, achieve complementary advantages through resource integration, and help promote industrial development and upgrading.
Public opinion warning
Guangji Pharmaceutical received a decision letter of administrative penalty of 1.5 million yuan
On July 22nd, Guangji Pharmaceutical (000952. SZ) announced that the company has received an "Administrative Penalty Decision" issued by the Hubei Regulatory Bureau of the China Securities Regulatory Commission. The company's subsidiary, Jikang Pharmaceutical, has guaranteed to the company and all members of the board of directors that the information disclosed is true, accurate, and complete, without any false records, misleading statements, or significant omissions. Some customers engage in distribution business as agents and should recognize revenue using the net amount method. Regarding the distribution business involved in the case, Jikang Pharmaceutical used the total amount method to recognize revenue, resulting in Guangji Pharmaceutical's Q1, Q2, and Q3 reports of 2022 overestimating operating revenue by RMB 45.6016 million, RMB 136.86 million, and RMB 138.2004 million, respectively, accounting for 25.49%, 26.68%, and 20.49% of the current operating revenue. Guangji Pharmaceutical was given a warning and fined 1.5 million yuan, and the responsible persons Ruan Shu and Hu Mingfeng were fined 800000 yuan each. The company has corrected the accounting errors in the previous period involved in this Administrative Penalty Decision, and there are no significant illegal forced delisting situations. Production and operation are normal.
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