Domestic Simegliptin "first certificate" is delayed? Multiple applicant companies claim that there is a data protection period after the patent cliff.

Following the expiration of the core compound patent of semaglutide, a blockbuster weight loss drug from Novo Nordisk A/S Sponsored ADR Class B (NVO.US) one month ago, there has not been a successful approval of a domestic semaglutide in China. Several domestic pharmaceutical companies that are in the review and approval stage for semaglutide biosimilars/improved drugs have disclosed their annual reports recently, with most of them still in the review and approval stage. One company has explicitly disclosed that the project's review has been "suspended". According to various interviews conducted by the financial news outlet, one reason for the delay in the issuance of the "first certificate" for the domestic semaglutide may be related to previously low profile data protection regulations. It is expected that the approval for market launch could be delayed by another year. The financial news outlet recently discovered that a fierce competition for the first approval of a domestic semaglutide has fallen silent since the expiration of the patent cliff for semaglutide injectables from Novo Nordisk A/S Sponsored ADR Class B, the "king of drugs" on March 20, 2026. Over a dozen pharmaceutical companies, including JIUYUAN GENE (02566), Livzon Pharmaceutical Group Inc. (000513.SZ), and Qilu Pharmaceutical, have already submitted applications for semaglutide market launch, with multiple varieties in the late stages of review. However, none of these companies have received the approval "permit" so far, and most recent annual reports indicate that the product is still in the review and approval stage. The 2025 financial report from JIUYUAN GENE revealed that the review of their semaglutide product is currently suspended due to data protection requirements under agreements with other countries' governments. Furthermore, the securities department of JIUYUAN GENE mentioned in response to inquiries from the financial news outlet that the core reason for not receiving the approval yet is that the data is still protected. Similarly, Livzon Pharmaceutical Group Inc. confirmed that their semaglutide approval is currently suspended due to the impact of the China-Switzerland Free Trade Agreement. Public information shows that the first domestically approved semaglutide (Debutai) in China is produced by Novo Nordisk A/S (the Danish parent company) and licensed by Novo Nordisk A/S Swiss subsidiary, Novo Nordisk Pharma AG, based in Zurich. Under the China-Switzerland Free Trade Agreement, both parties agree to protect undisclosed drug trial data for at least 6 years from the date of approval, prohibiting other applicants from relying on this data. Since the approval of semaglutide by Novo Nordisk A/S Sponsored ADR Class B in China in April 2021, the data protection period is set to expire in April 2027 if calculated for 6 years. A representative from the securities department of JIUYUAN GENE added, "It is currently in a state of suspension, and it is not clear whether the approval will be granted or not, so it is difficult to reach a conclusion." The company is currently in close communication with regulatory agencies regarding the "data protection" issue, but they cannot confirm if the approval will be obtained within this year. A representative from Livzon Pharmaceutical Group Inc. mentioned that they anticipate receiving approval in the second quarter of next year. They stated that all documents have been submitted, and the approval process is nearing completion. "We are currently waiting for the approval." A representative from UNITED LAB, who declared in their 2025 report that their semaglutide injections for diabetes have entered the production declaration stage, stated. When asked if the hindrance to obtaining approval is consistent with the "data protection" highlighted by JIUYUAN GENE, the representative responded, "The reasons for the delay in obtaining approval for all semaglutide products are the same. Please refer to our official announcements for specific details." "This is a legitimate and compliant strategy." Zhao Heng, founder of medical strategic consulting firm Latitude Health, stated in an interview with the financial news outlet that Chinese pharmaceutical companies still lack understanding of regulatory research, and their soft power needs to be improved. Legal departments of foreign pharmaceutical companies are crucial departments. Zhao Heng pointed out that the extension of the semaglutide protection period may further intensify the competition among domestic semaglutide generic companies: "Companies that were originally progressing faster are now forced to compete from the same starting line as other companies. When they all obtain approvals in a short period, it could lead to a more intense price war." While market concerns about a one-year delay in approval potentially causing loss of first-mover advantage persist, JIUYUAN GENE demonstrates confidence: "The first approval is still quite important. Even if it is postponed to next year, it won't be significantly delayed. This market is worth billions, and it's not likely that we can monopolize it all." The Livzon Pharmaceutical Group Inc. representative admitted that if other companies receive approval at the same time, the first-mover advantage will be compressed. However, they emphasized the cost advantage of their "self-produced raw materials." They stated, "We still have certain advantages in raw materials and costs, and competition in the future depends not only on the order of approvals but also on channels, costs, and market expansion capacity." They added, "We have done everything we can." According to the annual report of Novo Nordisk A/S Sponsored ADR Class B, the global sales of semaglutide products in 2025 amounted to approximately 228.288 billion Danish kroner (about $346 billion), contributing over 70% to the company's total revenue. In the Chinese market, semaglutide sales reached about 6.815 billion Danish kroner (approximately $1 billion). It is worth noting that while domestic semaglutide has not yet made a substantial impact, the pressure faced by semaglutide in the Chinese market is increasingly coming from positive competition from similar innovative drugs. Since the approval of teriparatide under the umbrella of LLY in China in 2024, there has been rapid growth, leading to its surpassing semaglutide globally in 2025. Teriparatide is also engaged in a positive price war with semaglutide in the domestic market. Reporters have attempted to contact Novo Nordisk A/S Sponsored ADR Class B in China on multiple occasions, but there has been no response to public phone calls. Source: Financial news outlet, Author: Lu A Feng, GMTEight Editor: Chen Qiuda