April Sees Surge in NMPA Notification Letters as Multiple High-Profile Drug Applications Rejected

　　【Pharmaceutical Network Industry Dynamics】 Currently, China's pharmaceuticals industry has entered a new phase of "strict regulation and high quality." The National Medical Products Administration (NMPA) is taking action from the source by implementing stringent controls on drug registration applications ("strict entry") and closely monitoring already marketed products ("strict management"), accelerating the elimination of outdated production capacity and ensuring public drug safety.
 

Notably, as the "pharmaceutical research" (CMC) and clinical data reviews for drugs are becoming increasingly stringent, the number of drug applications receiving "notification letters" is on the rise. Receiving a "notification letter" typically means that the application has not been approved, or the company has voluntarily withdrawn it. It is reported that this month, the NMPA has issued a large batch of notification letters, with several significant products failing to gain approval.
 

Daiichi Sankyo's Pexidartinib (Pexidartinib Hydrochloride) received a "Drug Notification Letter" and was not approved. The drug is indicated for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitation that cannot be improved by surgery.
 

Pexidartinib is a small molecule tyrosine kinase inhibitor. In August 2019, the FDA approved pexidartinib (Turalio) for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) who have severe morbidity or functional limitations and are not candidates for surgical improvement.
 

Qilu Pharmaceutical's Nusinersen Sodium Injection has received a notification. This drug is a small nucleic acid drug used to treat Spinal Muscular Atrophy (SMA), which falls under the category of orphan drugs originally developed by Biogen. In addition to Qilu Pharmaceutical, in September 2024, Chongqing Pharma-Younker also submitted an application for market approval, and Chengdu Guowei’s application is currently under review.
 

Chengdu Yundong's Morphine Sulfate and Naltrexone Hydrochloride Extended-Release Capsules have received a notification. This drug is a compound consisting of the opioid receptor agonist morphine and the antagonist naltrexone, which can reduce addiction rates, and the original research product has not been marketed in China. To develop this extended-release capsule, Chengdu Yundong has completed five PK/BE trials and one Phase III clinical trial. Additionally, in December 2025, another BE trial was conducted.
 

Jinling Pharmaceutical Company Limited's controlling subsidiary, Nanjing Jinling Pharmaceutical Factory, failed to obtain approval from the National Medical Products Administration (NMPA) for its application for Sevelamer Carbonate for Oral Suspension. The core reason is that the existing data cannot support the in vitro bioequivalence conclusion of the drug. Sevelamer Carbonate is a medication used to control hyperphosphatemia in patients with chronic kidney disease on dialysis. Prior to Jinling Pharmaceutical, three companies in China—Hangzhou Anyuan Biotechnology, Nanjing Hengsheng Pharmaceutical, and Kunming Becknorton Pharmaceutical—had already obtained approval for this drug.
 

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Overall, the recent wave of rejections is not simply a "tightening" of regulation; in fact, it reflects the pharmaceuticals industry entering a high-quality development phase. Against the backdrop of the continuous rise of innovative drugs produced in China and the ability to offer patients better options, Chinese regulatory authorities may impose increasingly stringent requirements for drug evaluation and approval in the future. This is expected to encourage良性 competition within the industry, keeping out "inferior capacity" with insufficient technical capabilities and weak compliance awareness, while creating more development opportunities for high-quality enterprises that promote innovation, adhere to quality, and comply with regulations.
 

　　Disclaimer: Under no circumstances shall the information or opinions expressed in this article constitute investment advice to any person.