The first generic version of smegglutide is getting closer and closer.
Yesterday, the CDE updated a common issue regarding peptide formulations, which can be seen as pointing out a direction for companies following suit.
Q: How should clinical trial applications and marketing authorization applications be submitted for polypeptide preparations developed using bio-fermentation-derived polypeptide preparations as control drugs and prepared by a fully chemical synthesis method?
A: If there are no similar products prepared entirely by chemical synthesis on the market, both domestically and internationally, the applicant may apply for a product in accordance with the category 2.2 of chemical drugs.
If there are already generic versions of the same drug prepared by full chemical synthesis on the market in China and abroad, the generic drugs already on the market overseas shall be submitted in accordance with the category 5.2 of chemical drugs, and the drugs produced by the applicant in China shall be submitted in accordance with the category 3 of chemical drugs (only if there are generic versions of the same drug prepared by full chemical synthesis on the market overseas) and category 4 (if there are generic versions of the same drug prepared by full chemical synthesis on the market in China).
The above-mentioned drugs do not require the publication of a reference formulation during the application process , but the applicant should select an original drug with complete safety and efficacy data as the control drug for the study. Drugs that meet the requirements for safety, efficacy, and quality controllability after review may be approved for marketing.
Upon approval, the registration category for this type of product is stated as "This product is submitted according to the chemical drug category 3/4/5.2 pathway".
Due to the complexity of the circumstances involved, such products may require necessary non-clinical and clinical studies. To reduce R&D risks, applicants should communicate and reach an agreement with the Center for Drug Evaluation on the selection of their control drugs and other pharmaceutical, non-clinical, and clinical technical issues before proceeding with the R&D application.

The core patent for the original Smegglutide injection expires on the 20th of this month, with only 3 days left in the countdown.
Several domestic companies have already set up counterfeit products, and as long as the products are approved for market launch, they can be sold legally.
Some of these products are being submitted as biosimilars (Class 3.3) while others are being submitted as generic chemical drugs. There is still disagreement about which approach is more reliable and economical.
Currently, the companies that have submitted applications are divided into two groups. The mainstream group is the "bio-based group," which applies for biosimilar drugs under category 3.3 . Representative companies include Jiuyuan Gene, Livzon Pharmaceutical Group, and Sino-American East China Pharmaceutical Group.
Another group is the "chemical group," which applies for chemical drugs under category 2.2. Representative companies are Qilu Pharmaceutical and Shijiazhuang Pharmaceutical Group.
All the companies that have filed for approval have conducted Phase III clinical trials. Generally, they first apply for the indication of lowering blood sugar, and then apply for the indication of weight loss.
For example, Jiuyuan Gene, which was the first to apply for approval, has completed Phase III clinical trials for two indications.
Qilu, which was submitted as a Class 2.2 chemical drug, has also submitted Phase III clinical trials for two indications. It has completed the hypoglycemic indication and just submitted the weight loss Phase III clinical trial this year.
Currently, the companies that have reported production are all large, well-funded manufacturers with substantial resources.
In April 2024, Hangzhou Jiuyuan became the first company to submit its production report. Almost a year has passed, and it is currently in the stage of supplementing information.
Recently, the company submitted another marketing application for a weight loss indication.

Lizhu, Qilu, Federal, Chia Tai Tianqing, Huadong, Shiyao, Fosun, and others are all unwilling to be absent from this generic drug war. The answer to who will cross the finish line first may be revealed soon!
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