China Approves New Class 1 Innovative Drug for Type 2 Diabetes; Multiple Candidates Enter Final Approval Stage

　　【Pharmaceutical Network Industry Dynamics] As the approval process for new drugs accelerates in China, an increasing number of products are speeding to market. Since entering November 2025, several Class 1 new drugs covering major disease areas such as cancer, diabetes, and autoimmune disorders have made new progress toward market entry.
 

　　China-Produced Class 1 New Drug Approved for Marketing
 

On November 14, PegBio's self-developed Class 1 innovative drug in China — Vipenatide Injection (PaiDaKang®) — was officially approved for marketing. The drug is indicated for glycemic control in adult patients with type 2 diabetes, improving glucose regulation through a GLP-1 receptor agonist mechanism.
 

Moreover, Pedicon® features a hidden needle design, allowing injection to be completed in two steps without the need for dose titration. The advantage of "starting dose as therapeutic dose" further enhances the medication experience and provides a new treatment option for diabetes patients in China.
 

　　Multiple New Drugs Enter the Final Stage of Market Launch in China
 

On November 20, Shanghai Henlius Biotech, Inc. announced that the innovative PD-1 inhibitor H drug Hansizhuang (Seriulimab, European trade name: Hetronifly) has been officially included in the list of breakthrough treatment drugs by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for neoadjuvant/adjuvant treatment of gastric cancer in combination with chemotherapy.
 

H Drug's Phase III Clinical Trial for This Indication Has Reached the Primary Endpoint. This Breakthrough Therapy Designation Demonstrates Recognition of H Drug’s Potential and Clinical Value in Perioperative Treatment of Gastric Cancer, and Will Accelerate Its Review and Market Approval Process.
 

On November 19, the CDE announced that Johnson & Johnson's Class 1 new drug, Ixekizumab Hydrochloride Tablets, had been submitted for marketing approval. It is indicated for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, as well as pediatric patients aged 12 years and older. On the same day, this indication was also included by the CDE in the proposed priority review.
 

Data shows that Icotrokinra Hydrochloride Tablets (Icotrokinra), a first-in-class oral peptide drug (IL-23R antagonist) introduced by Johnson & Johnson at a cost of nearly $1 billion from Protagonist, was submitted for marketing approval in the United States this July and in Europe this September. Johnson & Johnson expects the drug’s annual peak sales to exceed $5 billion.
 

On November 18, the CDE website showed that Boehringer Ingelheim's Class 1 new drug BI 764198 capsules are proposed to be included in the breakthrough treatment category, with the indication for: treating patients with primary focal segmental glomerulosclerosis (FSGS), adults and adolescent patients aged ≥12 years who weigh at least 40 kg. BI 764198 is an investigational oral selective TRPC6 inhibitor. Trial data show that this drug can reduce proteinuria levels in FSGS patients and is well tolerated.
 

Overall, since 2025, the research and development as well as the market launch of Class 1 new drugs in China have seen a significant surge. This is an inevitable outcome driven by the synergy of policy, industry, and capital. In the future, as the industry continues to focus on genuine clinical value and global strategic planning, an increasing number of new drugs with higher efficacy will be launched in China, providing more treatment options for patients. Meanwhile, more "global new" drugs originating from China that can address the suffering of patients worldwide will continue to emerge.
 

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