After the dispute, Bojian did not give up the Alzheimer's disease drug Aduhelm. The confirmatory clinical trial will be launched in May of the following year.

Finishingrainbow

On December 16, 2021, Bojian stated that it will start a confirmatory trial of Alzheimer's disease (AD) drug Aduhelm in May next year, and is expected to deliver data in 2026

Bojian said that the confirmatory study will recruit more than 1,300 patients with early-stage Alzheimer's disease from the United States and internationally, and compare Aduhelm with a placebo over a period of 18 months

It is worth mentioning that Aduhelm has been subject to controversy since its inception, and there have been constant disturbances——

Aduhelm's research and development treatment is based on the amyloid hypothesis, but this hypothesis itself is full of controversy.

Aduhelm was almost unanimously rejected by the FDA advisory committee due to the incompleteness of the clinical trial and the conflicting results of the two phase III trials

After Aduhelm received accelerated approval from the FDA in June, three FDA advisory committee experts resigned one after another in protest

Due to the lack of effective convincing results from the Aduhelm test, many doctors in the United States have publicly stated that they would not recommend the use of Aduhelm in clinical practice

On July 8, 2021, the FDA announced that it will reduce the scope and use of Aduhelm to make it consistent with the disease stage and population studied in clinical trials, and it will only be used to treat patients with mild symptoms of AD

After the commercialization of Aduhelm, patients receiving Aduhelm treatment need to be administered intravenously (about 1 hour) and monitored in the hospital.

In early November, an elderly patient died after receiving treatment with Biogen's Alzheimer's disease drug Aduhelm;

In November, Bojian received a "negative trend vote" from the European Medicines Agency's Committee on Pharmaceuticals for Human Use (CHMP) on Aduhelm's application, and CHMP rejected Aduhelm's listing in Europe

In early December, due to the dismal performance of Aduhelm and the failure of commercialization and listing, Bojian planned to lay off as many as 1,000 employees.

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Judging from the fact that Bojian is still actively preparing for Aduhelm's post-marketing confirmatory clinical trials, it seems that it has not given up on the development of the drug

In September 2021, lecanemab submitted a rolling license application (BLA) to the U.

In the future, which drug in the field of Alzheimer's disease will win, and Bojian will be more inclined to bet more on which drug? Sina Pharmaceuticals will continue to pay attention