Semaglutide Under Siege: Who Will Cross the Finish Line First?

Sep 19, 2024 14:14 CST Updated 14:14

Qilu Pharmaceutical

Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer

Novo Nordisk

Insulin Developer and Manufacturer

Recently, Qilu Pharmaceutical's semaglutide was submitted for marketing approval in China.This is already the third domestically produced semaglutide to be submitted for marketing in China., with the previous two approvals expected for Jiuyuan Gene in Q4 2025 and Livzon Group in Q1 2026, respectively.

Based on clinical progress, it is expected that the three semaglutide products applying for marketing authorization have all chosen Type 2 diabetes as the initial indication. Among them, Jiuyuan Gene has also applied for...Secondary Prevention of Cardiovascular Events in Patients with Diabetes.

Screenshot source: Insight Database

It is worth noting that，Qilu Pharmaceutical is declared as a Class 2.2 modified new drug under chemical pharmaceuticals.According to the statistical analysis of previous review timelines for different registration categories in the Insight database,The review period for improved new drugs is shorter than that for similar drugs.Therefore, based on the current data,Qilu Pharmaceutical is expected to be the first to receive approval for market launch (expected to be approved in 2025Q3).

InType 2 DiabetesIndications:Currently, there are 11 Chinese-produced semaglutide products under development.IIIPhase Clinical, including CSPC, CTTQ, United Laboratories, Hanmi Pharmaceuticals, Siho Pharma, China Resources Double-Crane, etc., indicating that the subsequent competition will be extremely fierce.

Novo Nordisk's financial report showsIn the first half of 2024, semaglutide achieved sales of nearly $13 billion, accounting for two-thirds of Novo Nordisk's total revenue. Among this, the injectable version for diabetes treatment, Ozempic, reached sales of $8.287 billion, marking a year-on-year increase of 36%.

InObesityIn terms of indications, there are currently no domestically produced drugs on the market.However, four China-produced semaglutide products have successively launched since September this year.IIIPhase Clinical, respectively from Hanyu Pharmaceutical (September 3), Livzon Pharmaceutical (September 6), Federal Pharmaceutical (September 11), and CSPC Pharmaceutical Group (September 13).

According to Novo Nordisk's financial report, the sales of Wegovy, the weight-loss version of semaglutide, reached $3.075 billion in the first half of 2024, representing a year-on-year increase of 74%.

Recently, domestic companies have launched an all-around offensive against semaglutide. Apart from its market potential, the key reason is that the core patent of the original research is about to expire in China.

According to the Insight database, the key patents for semaglutide in China currently include sequence patents, pharmaceutical use patents, and preparation/process patents, among whichCore sequence patent will expire on March 20, 2026.; Pharmaceutical use patents are currently alsoOnly covers the reduction of the risk of major adverse cardiovascular events (MACE) in patients with type 2 diabetes and high cardiovascular risk.。

Screenshot source: Insight Database

In short, once the core sequence patent of the original research expires, domestically produced semaglutide will quickly enter the market, dividing the domestic market. We expect that by 2026, there may be at least five versions of semaglutide in the Chinese market, making China the country with the most semaglutide biosimilars/new modified drugs globally.

Cover Source:Company Logo

Disclaimer:This article is for information sharing only and does not represent the position or viewpoint of Insight. It does not recommend or introduce any treatment plans. If necessary, please consult and contact正规医疗机构.

Editor：vvy

PR Article Coordination: WeChat insightxb

SubmissionWeChat: insightxb; Email: insight@dxy.cn

Diversified functions, traceable data……

Insight Database Web Version Awaits Your Experience

Click to read the original text,ImmediatelyUnlock！