news

한어Русский языкEnglishFrançaisIndonesianSanskrit日本語DeutschPortuguêsΕλληνικάespañolItalianoSuomalainenLatina

Securities Times reporter Chen Cheng

On the evening of August 13, Kangleweishi (833575) issued an announcement stating that recently, the company's independently developed recombinant trivalent human papillomavirus (type 16/18/58) vaccine (Escherichia coli) (hereinafter referred to as "trivalent HPV vaccine") Phase III protective efficacy clinical trial has completed the unblinding of the interim analysis, the main efficacy indicators and safety assessments by the Independent Data Monitoring Committee (IDMC), and the results are in line with expectations.

Tao Ran, CEO of Corolla, said that the positive results of Corolla's trivalent HPV vaccine in clinical trials are a reflection of the company's long-term R&D investment and teamwork spirit. The company will actively prepare relevant documents for the new drug marketing authorization application, maintain communication with the drug regulatory authorities on the application, and submit a biologics marketing application (BLA) as soon as possible to help the World Health Organization achieve the global goal of eliminating cervical cancer as soon as possible.

It is reported that the trivalent HPV vaccine independently developed by Kangleweishi is mainly used to prevent persistent infection and cervical cancer related to HPV16/18/58. In addition to the world's major high-risk types HPV16 and 18, the company's trivalent HPV vaccine also covers the third highest-risk subtype HPV58 that causes cervical cancer in East Asia. Compared with the currently available bivalent or quadrivalent HPV vaccines, the trivalent HPV vaccine will increase the protection of cervical cancer in East Asian women from 70% to 78%.

The announcement shows that the trivalent HPV vaccine of Kanglewei entered the Phase III clinical trial in October 2020. As of now, the sample testing of the 13th visit of the Phase III clinical trial has been completed, and the sample testing of the 14th visit is ongoing, and the number of cases of the primary endpoint required by the interim analysis node set in the protocol has been accumulated. With the completion of data cleaning and review, database locking, data unblinding, and major efficacy indicators and safety assessments, the company recently received a recommendation letter issued by IDMC based on the interim analysis results, which pointed out that the effectiveness results of the trial met the interim analysis statistical criteria preset in the protocol.

The positive progress made in the trivalent HPV vaccine is also expected to accelerate the launch of the company's nine-valent HPV vaccine under development.

While fully promoting R&D and clinical work, Kangleweishi is also continuously expanding its advanced production capacity. It has built an HPV vaccine industrialization base in Kunming in accordance with the GMP standards of China, the European Union and the World Health Organization, with a designed annual production capacity of 10 million doses of trivalent HPV vaccine and 30 million doses of nine-valent HPV vaccine. In August 2023, Kangleweishi (Kunming) officially started trial production. On August 2, 2024, Kangleweishi (Kunming) obtained the "Drug Production License" issued by the Yunnan Provincial Drug Administration, taking another step towards commercialization.