One month after the core compound patent for Novo Nordisk's (NVO.US) blockbuster weight-loss drug semaglutide expired, no domestic version of semaglutide has yet successfully gained approval. Several domestic pharmaceutical companies with semaglutide biosimilars or improved new drugs currently under review have recently disclosed their annual reports. The progress of most semaglutide projects remains in the review and approval stage, with one company explicitly disclosing that the review for its project has been "suspended." Through multiple interviews, it has been learned that a relatively overlooked data protection regulation is likely the main reason why domestic semaglutide has not yet received its first marketing authorization. Relevant companies anticipate that the approval and launch timeline may be delayed by another year.
A recent review found that following the "patent cliff" date of March 20, 2026, for the injectable formulation of Novo Nordisk's semaglutide in China—the former "king of drugs"—the heated competition among domestic drugmakers to secure the first approval has fallen silent. Over ten companies, including JIUYUAN GENE (02566), Livzon Pharmaceutical Group Inc. (000513.SZ), and Qilu Pharmaceutical, had already submitted marketing applications for semaglutide, with many products in the late stages of review, yet none have received approval so far. Recent annual reports from most companies indicate these products are still under review.
JIUYUAN GENE's 2025 financial report disclosed that the review for JIYOUTAI® (JIUYUAN GENE's semaglutide) is currently suspended due to data protection requirements under an agreement with another government. The company's securities department recently confirmed in a response that the core reason for not yet obtaining approval is that the relevant data remains under protection. Simultaneously, the securities department of Livzon Pharmaceutical Group Inc. also confirmed that its semaglutide approval process is currently suspended due to the impact of the China-Switzerland Free Trade Agreement.
Public information shows that the first semaglutide product (Novo Nordisk's Ozempic) approved for marketing in China was manufactured by Novo Nordisk A/S (Novo Nordisk's Danish parent company), with the marketing authorization holder being Novo Nordisk's Swiss subsidiary, Novo Nordisk Pharma AG, registered in Zurich, Switzerland. According to the China-Switzerland Free Trade Agreement, both parties must provide protection for undisclosed drug trial data for at least six years from the date of marketing approval, during which other applicants are prohibited from relying on this data. Since Novo Nordisk's semaglutide was approved in China in April 2021, the data protection period is set to expire in April 2027, based on the six-year term.
A representative from JIUYUAN GENE's securities department added that the situation is currently just suspended, with no definitive decision made, making it difficult to draw a conclusion. The company is maintaining close communication with regulatory authorities regarding this data protection matter, but it is uncertain whether approval can be obtained within this year. Livzon Pharmaceutical Group Inc.'s securities department indicated that approval is expected in the second quarter of next year, stating that from the company's perspective, all submitted materials and approval processes have reached the final stage. A representative from Federal Pharmaceutical, which stated in its 2025 annual report that its "Semaglutide Injection (for diabetes indication) has entered the production application stage," similarly commented that they are currently awaiting approval. When asked if the reason for the approval delay aligns with the "data protection" issue mentioned by JIUYUAN GENE, the representative noted that the reasons for the delayed approvals are the same across companies and referred to official announcements for specifics.
"This is a legitimate and compliant strategic utilization," stated Zhao Heng, founder of healthcare strategy consulting firm Latitude Health, commenting that Chinese pharmaceutical companies still have relatively weak expertise in regulatory research and need to improve their soft skills. Legal departments in foreign pharmaceutical companies are typically key units. Zhao Heng pointed out that the extension of semaglutide's protection period may intensify competition among domestic semaglutide generic manufacturers: "Companies that were initially ahead are now forced to start from the same line as others. When approvals are granted densely around the same time, the resulting price competition could become more intense."
Regarding market concerns that a one-year delay might cause a loss of first-mover advantage, JIUYUAN GENE displayed resilience, noting that being among the first to launch remains important. Even if the first batch launches next year, the number of competitors initially will not be very large, implying only a one-year delay. Furthermore, they emphasized that the market is worth tens of billions, and it is unrealistic for any single company to capture it entirely. The representative from Livzon Pharmaceutical Group Inc. acknowledged that if other companies receive approval around the same time, the first-mover advantage would be reduced. However, they highlighted the company's cost advantage from self-producing active pharmaceutical ingredients, stating that subsequent competition will depend not only on the timing of approval but also on channels, costs, and market expansion capabilities, adding that all possible efforts have been made.
According to Novo Nordisk's annual report, in 2025, global sales for the entire semaglutide product line were approximately 228.288 billion Danish kroner (roughly $34.6 billion), contributing over 70% to the company's total revenue. Sales in the Chinese market accounted for about 6.815 billion Danish kroner (approximately $1 billion). Notably, even before domestic semaglutide products pose a substantial challenge, semaglutide already faces increasing pressure in the Chinese market from competition with similar innovative drugs. Eli Lilly's (LLY) tirzepatide, approved in China for relevant indications since 2024, has seen rapid sales growth. Its global performance led it to surpass semaglutide and become the top-selling drug globally in 2025. Furthermore, tirzepatide is engaging in direct price competition with semaglutide within China.
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