Before 2016, if the revenue ratio was used as an identification indicator, all pharmaceutical companies listed on the A-share market were "generic drug" companies. Until the emergence of Beida Pharmaceuticals. Beida Pharmaceuticals was established in 2003 and has long focused on the development of small molecule innovative drugs in the field of lung cancer. Its drug Icotinib is my country's first small molecule targeted anticancer drug with completely independent intellectual property rights, and it is also the first independent innovative drug with annual sales of more than 1 billion yuan. On November 7, 2016, Beida Pharmaceuticals was successfully listed on the Growth Enterprise Market, becoming the first pharmaceutical company in the A-share market whose main income comes entirely from innovative drugs, and is known as the "first innovative drug stock." In December 2024, after experiencing the previous layoffs, Beida Pharmaceuticals ushered in another important milestone in its development history.

On December 19, Beida Pharmaceuticals announced that its holding subsidiary Xcovery's application for Ensatinib Hydrochloride Capsules (trade name: Ensacove) "intended for the treatment of adult patients with ALK-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not received anaplastic lymphoma kinase (ALK) inhibitors before" (i.e., first-line indication) has been approved for marketing by the US FDA. This is the first small molecule lung cancer targeted drug launched globally by a Chinese company, and it is also the first product of Beida Pharmaceuticals to successfully go overseas.

Ensatinib is a new generation of highly selective ALK inhibitors jointly developed by Beida Pharmaceuticals and Xcovery. Previously, the drug has been approved for marketing in China for first-line and second-line indications of ALK-positive locally advanced or metastatic NSCLC, and has been included in the national medical insurance catalog. Ensatinib's FDA approval was based on an international multicenter Phase III clinical trial involving 123 research centers in 21 countries and regions. In the context of the failure of many domestic innovative drugs to go overseas in the past two years, Beida Pharmaceuticals was able to complete the international multi-center clinical trial of Ensartinib of the above scale and finally successfully obtain approval, showing that the company has a certain international operation capability. Of course, the operation capability is only a foundation. The final approval of the drug is still based on the high-quality clinical effect advantage.

The results of the clinical trial showed that the median progression-free survival (mPFS) of patients with ALK-positive non-small cell lung cancer (NSCLC) treated with Ensartinib was significantly longer than that of patients treated with the reference drug Crizotinib. The research results have been published in the top international medical journal "Journal of the American Medical Association Oncology". Crizotinib is an ALK/MET/ROS1 inhibitor developed by Pfizer. It was approved by the US Food and Drug Administration (FDA) in August 2011 for the treatment of non-small cell lung cancer (NSCLC) with anaplastic lymphoma kinase (ALK) gene rearrangement.

In other words, the successful approval of Ensartinib is based on the "head-to-head" victory over competing drugs. From this perspective, this is a very hardcore victory. At present, there are 5 small molecule drugs approved for the treatment of ALK-positive NSCLC in the US market. According to the US NCCN guidelines, for patients with advanced or metastatic NSCLC with ALK fusion-positive, the first-line recommendations are: alectinib (priority), brigatinib (priority), lorlatinib (priority), ceritinib and crizotinib. Among them, the sales amount of alectinib in 2023 reached 1.7 billion US dollars. After the successful listing, how much market will ensartinib be able to cut will become the most concerned issue for investors.

In any case, for Beida Pharmaceuticals, which has been slightly weak in growth in the domestic market, the successful listing of ensartinib will undoubtedly bring a new growth point.

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