Domestic Semaglutide 'First Approval' Delayed: Multiple Applicants Cite Data Exclusivity Beyond Patent Cliff

Cailian Press, April 23 (Reporter Lufeng Lu)Following the expiration of the core compound patent of Novo Nordisk's重磅 weight-loss drug, semaglutide, a month ago, no domestically produced semaglutide in China has successfully been approved yet. Recently, several Chinese pharmaceutical companies with semaglutide biosimilars or改良 new drugs in the review and approval stage have disclosed their annual reports. The progress of most semaglutide products remains in the review and approval stage, and one company has explicitly disclosed that the project’s review has "been suspended." According to interviews conducted by reporters from Cailian Press, a previously less-noticed data protection regulation may be the main reason why domestically produced semaglutide has not yet received the “first approval.” Companies expect the approval for market launch may be delayed by another year.

Reporters from Cailian Press recently tracked and found that after March 20, 2026, the "patent cliff" date for Novo Nordisk's former "drug king" — semaglutide injection in China, a heated competition among domestically produced drugs over "who can obtain the first approval" has fallen silent. Including Hangzhou Jiuyuan Gene Engineering Co., Ltd.,Livzon Pharmaceutical Group Inc.More than ten pharmaceutical companies, including Qilu Pharmaceutical, have already submitted the marketing application for semaglutide, and several varieties are in the late stage of review, but none has obtained an approval "pass" so far. The annual reports recently disclosed by most companies show that this product is still in the review and approval stage.

Jiuyuan Gene's 2025 earnings report disclosed that, due to Geuotai® (Jiuyuan Gene’s semaglutide) "being subject to data protection agreements with other national governments, the review of this product is currently on hold."

Hangzhou Jiuyuan Gene Engineering Co., Ltd. (02566.HK) recently told a reporter from Cailian Press, who called in as an investor, that the main reason for not yet obtaining the approval document is that the relevant data is still under protection. Meanwhile, the securities department of Livzon Pharmaceutical Group Inc. (000513.SZ) also confirmed that due to the impact of the China-Switzerland Free Trade Agreement, the company’s semaglutide approval process is currently on hold.

Public information shows that the first batch of Semaglutide (Novo Nordisk) approved for marketing in China was manufactured by Novo Nordisk A/S (the Danish parent company of Novo Nordisk), and the marketing authorization holder is Novo Nordisk's Swiss subsidiary, Novo Nordisk Pharma AG, which is registered in Zurich, Switzerland.

According to the "China-Switzerland Free Trade Agreement," the contracting parties should provide a protection period of at least 6 years for undisclosed pharmaceutical test data from the date of marketing approval, during which other applicants are prohibited from relying on such data.

Since Novo Nordisk's semaglutide was approved in China in April 2021, if following a 6-year data protection period, the data protection expiration date will be April 2027.

A representative from Jiuyuan Gene's securities department further stated, "It is currently in a suspended state; there has been no approval or rejection, so it is difficult to draw a conclusion." The company is currently maintaining close communication with the regulatory authorities regarding this "data protection" matter, but as for whether they can obtain the approval document within this year, "it is also hard to say at this point."

The Securities Department of Livzon Pharmaceutical Group Inc. indicated that the approval is expected to be obtained in the second quarter of next year, "From the company's perspective, we have submitted all the required documents, and the approval process has reached the final stage."

"We are also currently waiting for the approval." In the 2025 annual report, a representative from the Securities Department of Federal Pharmaceutical, which stated that "Semaglutide Injection (for diabetes indication) has entered the production declaration phase," made this comment. When pressed by a reporter, posing as an investor, whether the obstacle to obtaining the approval was related to the "data protection" issue raised by Hangzhou Jiuyuan Gene Engineering Co., Ltd., the representative responded, "The reason for not obtaining the Semaglutide approval is the same for everyone at this stage; please refer to our official announcements for specifics."

"This is a legitimate and compliant strategy utilization." Zhao Heng, founder of Latitude Health, a medical strategic consulting firm, said directly in an interview with the Financial News Agency, that Chinese pharmaceutical companies are still relatively weak in understanding how to study regulations, and their soft power needs improvement. The legal departments of foreign pharmaceutical companies are all key departments.

Zhao Heng pointed out that the extension of the protection period for semaglutide may further intensify the "internal competition" among Chinese semaglutide generic drug companies: "The companies that were originally ahead in progress are now forced to stand on the same starting line as other companies. When approvals are densely obtained, the resulting price war could become even more intense."

Regarding market concerns that a one-year delay in the approval might lead to the loss of a first-mover advantage, Hangzhou Jiuyuan Gene Engineering Co., Ltd. demonstrated considerable composure: "The first batch's market entry is still quite important. Even if the first batch is delayed until next year, it won’t be excessively large — it’s merely a one-year postponement. Moreover, this is a billion-dollar market; it’s not feasible for us to capture it entirely anyway."

The above-mentioned person from the Securities Department of Livzon Pharmaceutical Group Inc. admitted that if other companies are approved during the same period subsequently, the first-mover advantage will be compressed. However, they emphasized the company's cost advantage of "self-produced raw materials," stating, "We still have a certain advantage in active pharmaceutical ingredients and cost. Subsequent competition will not only depend on the order of approval but also on channels, costs, and market expansion capabilities." They also mentioned that "all possible efforts have been made."

According to Novo Nordisk's annual report, by 2025, the global sales of the entire Semaglutide product line will be approximately 228.288 billion Danish kroner (about 34.6 billion US dollars), contributing over 70% to the company’s total revenue. Among this, the sales of Semaglutide in the Chinese market will be approximately 6.815 billion Danish kroner (about 1 billion US dollars).

Notably, before the domestically produced semaglutide has formed a substantial impact, the pressure on semaglutide in the Chinese market has increasingly come from direct competition with similar innovative drugs. Since Eli Lilly's tirzepatide was approved for relevant indications in China in 2024, it has rapidly gained market share. Its global performance has already positioned it to surpass semaglutide as the world’s top "blockbuster drug" by 2025, and tirzepatide is also engaging in a direct price war with semaglutide within China.

Reporters have repeatedly tried to contact Novo Nordisk China recently, but the public phone has been unanswered.