On September 2^nd, 2019, Betta Pharmaceuticals Co., Ltd. announced that due to the continuing therapeutic effects of ensartinib hydrochloride presented in the clinical studies, the independent review committee (IRC) evaluated the new clinical data updated till May 2019 and updated the clinical data in the new drug application (NDA).

The NDA submission of ensartinib hydrochloride (X-396) is based on the consistent efficacy and the good safety profiles of X-396 on the anaplastic lymphoma kinase (ALK) positive NSCLC patients resistant to crizotinib in a single arm, multi-center phase II study. For the updated data of ensartinib hydrochloride released on May 2019, the overall ORR was 52.6%, the overall DCR was 87.8%, the median PFS was 11.2 months, the intracranial ORR was 71.4%, and the intracranial DCR was 95.2%. According to the data as of mid-September 2018 evaluated by the IRC, the overall ORR was 48.7%, the DCR was 87.8%, the median PFS was 9.7 months, the intracranial ORR was 66.7%, and the intracranial DCR was up to 92.8%, meeting the expectation of the study. Comparing the two datasets, the latest data have an improved overall DCR, and continue showing good efficacy readouts. The drug toxicity was manageable, and the most common AEs were rash and moderate increases of ALT and AST, which can be relieved or cured through targeted treatments or drug discontinuation.

Ensartinib hydrochloride is a novel, potent and highly selective next-generation ALK inhibitor, which is jointly developed by Betta and its subsidiary Xcovery Holding, Inc.. In December 2018, the CDE accepted the NDA of ensartinib hydrochloride on the ALK+, locally advanced or metastatic NSCLC patients who have previously received the crizotinib treatment or were intolerant to crizotinib. The CDE has granted the NDA for accelerated review in February 2019, and Betta is currently submitting supplementary materials to cooperate with the CDE on further reviews. Betta is conducting multiple clinical trials globally, one of which – the global multi-center phase III study for the first-line treatment of patients with ALK+ NSCLC – is progressing accordingly. Ensartinib hydrochloride is expected to become the first innovative drug to be globally launched independently by a Chinese company.

Professor Li Mao, Betta’s senior vice president and the chief medical officer, commented, according to the clinical data, ensartinib hydrochloride has a superior efficacy profile through its high respond rate in intracranial metastatic patients and a superior safety profile, compared to the approved therapies of the same class, and it can provide a new treatment option for ALK+ NSCLC patients. Betta will continue the market launch preparation, and look forward to the launch of ensartinib hydrochloride, which will meet the unmet clinical need of lung cancer patients.

About ensartinib hydrochloride

Ensartinib hydrochloride is a novel, potent and highly selective next-generation ALK inhibitor, and is developed jointly by Betta and its subsidiary Xcovey Holding, Inc. (Xcovery). Ensartinib targets locally advanced or metastatic ALK+ NSCLC patients whose diseases have progressed after crizotinib treatment. Since there is no domestically developed ALK inhibitor approved in China, ensartinib will fulfill the unmet medical needs of Chinese patients.

About Betta Pharmaceutical Co., Ltd.

Betta Pharmaceuticals Co., Ltd. (Stock code: 300558.SZ) is a national level high-tech enterprise, established by the experienced talent team of overseas returnees, with research and development (R&D) of innovative drugs as its core focus, integrating R&D, manufacturing and marketing. The company independently developed China's first small-molecule targeted anticancer drug, icotinib hydrochloride (trade name: Conmana). It was recognized as a major breakthrough in the Chinese public healthcare industry and has won China Patent Gold Award twice as well as the first National Scientific and Technological Progress Award in China's chemical and pharmaceutical industry. Until the third quarter in 2019, icotinib has benefited 230,000 patients of advanced lung cancer, with the cumulative sales reaching nearly 7 billion RMB. The company has established a comprehensive new drug R&D platform, with its R&D centers in Hangzhou and Beijing, and more than 30 innovative drugs under development, covering multiple tumor indications such as lung cancer, renal cancer, and breast cancer. The company has also reached strategic collaboration with leading domestic and foreign pharmaceutical companies such as Amgen, Xcovery, Tyrogenex, Merus, Mabworks, and InventisBio, to work together to promote the health and well-beings of the general public.