Ensartinib (X-396): A Next-Generation ALK Inhibitor for NSCLC and Beyond – IPO Prospectus Filed by Xcovery, a Wholly-Owned Subsidiary of Betta Pharmaceuticals

EnsartinibEnsartinib

CAS:1370651-20-9

R&D Code:X-396

Original Research Company:Xcovery(Already controlled by Betta Pharmaceuticals)

Collaborative R&D:AstraZeneca, Betta Pharmaceuticals,Xcovery(Already controlled by Betta Pharmaceuticals)

Indications:Non-Small Cell Lung Cancer（Listed); Central Nervous System Cancer; Malignant Melanoma; Non-Hodgkin's Lymphoma; Solid Tumors (Phase II Clinical）

2018Year12In the month, Ensartinib Hydrochloride submitted a new drug marketing application (NDA）。

2019Year2In the month, Ensartinib Hydrochloride was approved by the National Medical Products Administration (NMPA) Included in the Priority Review List.

2019Year12Month31Date: Led by Professor Zhang Li from the Sun Yat-sen University Cancer Center, Ensartinib in ChinaⅡThe results of the Phase III registrational clinical trial were officially published in the international authoritative journal The Lancet.•Respiratory Medicine", Impact Factor22.992。International Oncology Expert, University of Colorado Cancer CenterRoss CamidgeThe professor commented in the preface that ensartinib has definite efficacy and good safety.“Can be used as an option after crizotinib resistance.”，“May even become a potential first-line treatment option”。

2020Year8Month8Day, Ensartinib Hydrochloride International MulticenterⅢInterim analysis results of Phase III clinical study by Vanderbilt University, USALeora HornDr. at the World Conference on Lung Cancer (IASLC WCLC) Released at the Presidium Seminar. The results showed that patients treated with EnsartinibALKPositive Non-Small Cell Lung Cancer (NSCLC) patients, with a median progression-free survival (mPFS) was significantly longer than that of patients treated with crizotinib.

2020Year11Month, National Medical Products Administration (NMPA) Approval for the issuance of the "Drug Registration Certificate" (Drug approval number: National Drug Approval No.H20200009、Approval Number of National MedicineH20200010), Ensartinib Hydrochloride Capsules have been officially approved for marketing in China. They are suitable for patients with anaplastic lymphoma kinase (ALK) Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) Treatment of patients.

2020Year12In the month, the first shipment ceremony of Ensartinib Hydrochloride was held at the headquarters of Betta Pharmaceuticals in Hangzhou, and the first prescription in China was issued in Guangzhou, officially beginning to benefit patients.

2021Year1Month, Ensartinib HydrochlorideeXalt 3 The latest research data were presented by Professor Wu Yilong, an oncology expert from Guangdong Provincial People's Hospital.2020Annual World Lung Cancer Conference (WCLC) was published.7In the month, the marketing application for ensartinib hydrochloride as a first-line treatment was accepted.8In the month, the first-line treatment indication for Ensartinib Hydrochloride was included in the priority review.

2021Year9Monthly, Ensartinib Hydrochloride Global First-LineeXalt 3Research results inJAMA OncologyPublished.12In the month, Ensartinib Hydrochloride was included in the National Medical Insurance Catalog.

2022Year3In the month, Ensartinib Hydrochloride Capsules received approval for first-line treatment indication in China.

2023Year6Month16Day，Betta Pharmaceuticals stated on the investor interaction platform that the company is actively promoting the overseas application project for Ensartinib.。

The above information is partially reproduced from the official website of Betta Pharmaceuticals.

On December 18, 2024, Ensartinib's first-line indication was approved for marketing by the U.S. Food and Drug Administration (FDA). February 2025On the 13th, Betta Pharmaceuticals announced that its holding subsidiary, Xcovery, submitted a letter of intent to the European Medicines Agency, officially launching the marketing approval process for ensartinib hydrochloride capsules "intended for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors are positive for anaplastic lymphoma kinase (ALK)" (i.e., first-line indication).

References:US10899744

References:US20160068493