Novo Nordisk Applies for Approval of Game-changing Weight-loss Drug Simeglerotide in China 世界即时看
2023-06-07 05:32:24
BEIJING, June 6 (TiPost) -- Novo Nordisk has submitted application for the approval of semaglutide injection for weight loss to China"s regulator, according to the website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration.
Semaglutide is a human glucagon-like peptide-1 (GLP-1) receptor agonist. It is a hypoglycemic drug with weight loss effectsThe exploration of GLP-1 drugs in the field of weight loss has been highly anticipated by the market.
(相关资料图)
In the European and American markets, semaglutide injection has been called the "miracle weight loss drug" and has been approved for hypoglycemic and weight loss indications. The brand names are Ozempic and Wegovy, respectively.
In the China market, semaglutide has only been approved for hypoglycemic indications and not for weight loss indications.
In April 2021, the National Medical Products Administration approved the listing of semaglutide injection pens with doses of 0.5mg and 1mg for the treatment of adult type 2 diabetes and the reduction of cardiovascular adverse events in patients with T2DM.
This submission by Novo Nordisk for a new indication for semaglutide injection in China may once again attract attention to this field. Once the process goes smoothly, the "miracle weight loss drug" will officially enter the domestic market, which may have a significant impact on the future market space and pattern of weight loss drugs in China.
Affected by this news, the concept stocks related to semaglutide continued to ferment after the opening on June 6th. In A-shares, related concept stocks such as Notaibio (688076.SH), Shengnuo Biotechnology (688117.SH), Huadong Medicine (000963.SZ), and Hanyu Pharmaceutical (300199.SZ) all rose to varying degrees.
Among them, Notaibio led the way with a rise of more than 19% during the session. As of the close of A-shares on June 6th, Notaibio"s stock price closed at 39.79 yuan, up 11.49%, with a turnover of 646 million yuan; Shengnuo Biotechnology"s stock price closed at 39.36 yuan, up 1.73%, with a turnover of 157 million yuan; Huadong Medicine"s stock price closed at 40.27 yuan, up 1.82%, with a turnover of 677 million yuan; Hanyu Pharmaceutical"s stock price closed at 12.57 yuan, up 4.23%, with a turnover of 1.09 billion yuan.
However, the performance of H shares is not satisfactory. As of the time of publication, the stock price of Sinobioway (01801.HK) was HKD 36.3, down 1.76%, with a turnover of HKD 208 million; the stock price of Livzon Pharmaceutical Group Inc. (02157.HK) was HKD 6.34, down 4.95%, with a turnover of HKD 6.5291 million.
In terms of market news, if Semglee is successfully listed in China, Novo Nordisk will also face tough market competition. Currently, there are multiple GLP-1 varieties in China"s late stage, and the competition in the weight loss market may be reshaped. Among them, Sinobioway is the most competitive domestic player, and its MsdT peptide can achieve better weight loss effects with relatively low dosage and shorter duration of use compared to similar products.
On May 11th this year, Sinobioway announced that the high dose (9mg) of MsdT peptide had achieved the primary endpoint of a 24-week clinical trial in obese patients in China.
In terms of efficacy, according to the clinical phase II data, the average weight loss percentage of the 9mg MsdT peptide group after 24 weeks of use can reach 15.4%, and the weight can be reduced by 14.7kg. Currently, the clinical trial is still ongoing, and the trial is expected to be extended to 48 weeks. Other secondary endpoint data will be disclosed later.
In terms of safety, according to the clinical phase II data, the 9mg MsdT peptide group has good tolerance and safety, and no subjects terminated treatment due to adverse events or experienced serious adverse events. The most common adverse events were gastrointestinal adverse events, most of which were mild or moderate and similar to most GLP-1 drugs.
In addition, MsdT peptide of Sinobioway also showed better weight loss effects at lower doses. Clinical data shows that after continuous use for 24 weeks at doses of 3mg, 4.5mg, and 6mg, the weight percentage changes in the three dose groups were -8.26%, -11.60%, and -12.62% respectively compared with the placebo group. Such clinical results have exceeded the injection effect of Semglee for 68 weeks.
Even if Semglee is listed in China first, domestic manufacturers still have the opportunity to catch up. Because Novo Nordisk"s production capacity is quite serious, it may not be able to fully expand sales in the huge domestic market.