NMPA Issues 87 Notification Letters, Including Rejections for Several High-Profile Drug Applications

Issued by the National Medical Products Administration2026Year04Month14Delivery Information of Japanese Pharmaceutical Notifications, this batch has a total of87A notification was received for the application number., wherein:

Qilu Pharmaceutical's Nusinersen Sodium Injection Receives Notification, As A Rare Disease Drug, The Original Research Drug's Price Dropped From 700,000 Yuan Per Injection To 30,000 Yuan. Later, Qilu, As The Leading Generic Manufacturer In China, Initiated A Generic Challenge For This Product.

Zhejiang Shengzhao Pharmaceutical's injectable Leuprolide Acetate Microspheres have received a notification letter. As an emerging company in complex formulations, Shengzhao has taken on the challenge of this microsphere but unfortunately received the notification letter. Currently, the marketing authorization for injectable Leuprolide Acetate Microspheres is held only by the original developer Takeda and Shanghai Lizhu.

Bilastine has issued four consecutive notices, respectively for: Kelun's orally disintegrating tablets, and oral solutions from Jiangsu Changtai Pharmaceutical, Zhuhai Beishan, and Hainan Hailing Chemical.

Humanwell Pharmaceutical's Extended-Release Dexmethylphenidate Hydrochloride Capsules have received a notification. Currently, this product is exclusively marketed by Henan Zhongshuai Pharmaceutical in one specification. Humanwell is striving to become the second manufacturer. The two acceptance numbers rejected this time were not under review for long, possibly due to voluntary withdrawal. Humanwell has since resubmitted the marketing application a few days ago.

In addition, Daiichi Sankyo's Pexidartinib Hydrochloride Capsules have received a notification letter for the indication of treating adult patients with symptomatic tenosynovial giant cell tumor (TGCT) accompanied by severe lesions or functional limitations that cannot be improved through 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. This also made the drug the first and only approved treatment for TGCT.

The complete batch information is as follows:

Source: PharmaCircle Headlines

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