Beijing, September 6, 2024 – Hanyu Pharma Co., Ltd. (Stock Code: 300199), a leading pharmaceutical company in China, recently announced the public disclosure of its Phase III clinical study plan for Semicarbazide injection for weight loss. This marks a significant milestone in the company’s research and development efforts, as it becomes the first domestic pharmaceutical company to enter the Phase III clinical trial for weight management with Semicarbazide injection.
The clinical study plan for Semicarbazide injection, which is registered under the number CTR20243301, was publicly disclosed on September 2, 2024, on the Pharmaceutical Clinical Trial Registration and Information Disclosure Platform. The study aims to evaluate the efficacy of Hanyu Pharma’s Semicarbazide injection (HY310 injection) in treating obesity when used in conjunction with lifestyle interventions. The primary comparator in the study is the original Semicarbazide injection (Novo Nordisk’s NovoPen®).
The Phase III clinical trial is designed to include a total of 408 participants. The study will be conducted under rigorous scientific and ethical standards to ensure the safety and effectiveness of the Semicarbazide injection. The primary endpoint of the trial is the percentage of participants achieving a significant weight loss, while secondary endpoints include changes in body mass index (BMI), waist circumference, and other relevant metabolic parameters.
Hanyu Pharma has been actively involved in the research and development of Semicarbazide injection for weight loss. The company’s research team has been working closely with domestic and international experts to ensure the quality and safety of the product. This Phase III clinical trial is a testament to the company’s commitment to providing innovative and effective solutions for the treatment of obesity.
The announcement of the Phase III clinical study plan has been well-received by the market and investors. Hanyu Pharma’s stock price has experienced a surge following the disclosure, reflecting the positive outlook for the company’s future prospects.
It is worth noting that obesity is a significant public health concern worldwide, with millions of people suffering from the condition. Effective weight loss treatments are in high demand, and the development of Semicarbazide injection could provide a much-needed solution for patients.
The Phase III clinical trial is expected to be completed within the next few years, and the results will be submitted to relevant regulatory authorities for approval. If approved, Semicarbazide injection could become a key treatment option for obesity in China and other countries.
In conclusion, Hanyu Pharma’s recent public disclosure of the Phase III clinical study plan for Semicarbazide injection for weight loss marks a significant achievement for the company. As the first domestic pharmaceutical company to enter the Phase III clinical trial for this indication, Hanyu Pharma is well-positioned to contribute to the global fight against obesity. The successful completion of the trial and subsequent approval of the product could result in significant revenue growth for the company and provide hope for millions of patients suffering from obesity.
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