NMPA Issues 35 Rejection Notices Including GSK's Hepatitis B Functional Cure Drug Bepirovirsen
GSK China
Pharmaceutical Manufacturer
Biogen
Neuroscience Drug Developer
Qilu Pharmaceutical
Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer
On May 25, the official website of the NMPA showed that 35 notification documents were issued, with the reviews of several blockbuster drugs encountering setbacks. Among them,GlaxoSmithKline (GSK)highly anticipatedNovel Drug for Functional Cure of Hepatitis BBepirovirsen InjectionProminently listed, yet failed regulatory review; butBlockbuster Rare Disease DrugNusinersen Sodium Injection, including domestic generic drugs; the current generic manufacturers for this product areComplete failure; none passed the consistency evaluation, the generic oligonucleotide sector faces another heavy blow.
Screenshot source: NMPA
01
Blockbuster Hepatitis B Drug Suddenly Faces Regulatory Review Setback
Beprovirsen（Bepirovirsen，GSK836）Originally developed by Ionis and licensed to GSK.World's First Antisense Oligonucleotide (ASO) Therapy, once regarded as the "star drug" for the functional cure of hepatitis B. The indication submitted in this application isFinite-Duration Treatment for Adults with Chronic Hepatitis B, precisely targetNucleos(t)ide analogue-treated, HBsAg ≤ 3000 IU/mL, non-cirrhoticpatient population. It is worth noting that,March 2026, this indication has just been approved by the CDE for inclusionPriority Review, at that time, the industry widely expected approval within the year, but this time it was suddenly issued a regulatory notice,The reason has not yet been disclosed., uncertainty surrounding subsequent developments has increased sharply.
Screenshot Source: Global Drug R&DDatabase(Search data. Find MoEnt.)
AsTriple Mechanismthe first-in-class drug,`Bepravirsen`Capable of precisely degrading hepatitis B virus (HBV) RNA, inhibiting viral DNA replication, potently reducing HBsAg levels, and activating host immunity, it holds promise to overcome the long-term treatment dependency associated with current hepatitis B therapies. In August 2019, GSKUSD 262 millionUpfront payment + milestone payments secured global development and commercialization rights from Ionis. Phase III clinical data demonstrated that its functional cure rate is significantly superior to standard therapy, and it was once highly anticipated to reshape the hepatitis B treatment landscape.
02
Complete Failure in Generic Development of Exorbitantly Priced Rare Disease Drugs
SameNusinersen Sodium InjectionThe generic drug applications were completely rejected, becoming another major focus in the industry. This drug, used for treating5q Spinal Muscular Atrophy (SMA)orphan drug, originally developed by Biogen, once due to “RMB 700,000 per dose”'s exorbitant price sparked heated debate, later reduced to approximately 30,000 RMB per injection following national medical insurance negotiations, with an urgent clinical need. Currently, in China, there are a total of3 companiesSubmit Generic Marketing Authorization Application:
Chongqing Pharmfriend:First submitted in September 2024, underwent review for over 300 days, and received an official regulatory notice in November 2025 with no opportunity for supplementary submission;
Qilu Pharmaceutical:January 3, 2025Submitted immediately thereafter, and likewise received the notification document on April 13, 2026;
Chengdu Guowei:March 2025Application submitted. Received notification on May 25, 2026. As of now, in ChinaNusinersen SodiumNot a single generic drug has passed the consistency evaluation, and the difficulty of developing generic small nucleic acid drugs far exceeds expectations. Industry analysis points out that the complex structural characterization, high challenges in impurity control, and significant technical barriers in synthetic processes, coupled with the fact that most companies in China have not yet conducted Phase III clinical trials—resulting in insufficient safety and efficacy data—are likely the core reasons for their successive regulatory rejections.
Screenshot source: China Drug Evaluation Database (Search Data. Find Menet)
The centralized issuance of 35 regulatory notices, coupled with the setbacks faced by two blockbuster drugs, reflects the current landscape of pharmaceutical review in China...Two Major Trends: The review process for innovative drugs is becoming increasingly refined, and the threshold for high-end generic drugs has been raised. The setback with bepirovirsen has delayed the "Chinese timeline" for a functional cure of hepatitis B; while the complete failure of nusinersen generic applications indicates thatThe Path to Improving Access to Rare Disease Medications Remains Long。
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