Betta Pharmaceuticals Co., Ltd.

Betta Pharmaceuticals is a national-level high-tech pharmaceutical company founded by a team of PhD returnees. It is an integrated organization of research and development, manufacturing, sales and marketing with emphasis on R&D of innovative drugs with proprietary intellectual property rights. We have always been committed to the research and development (R&D) of oncology therapies that are recognized as being innovative through the Category 1 classification by the NMPA and intended to address unmet medical needs including those in lung and other large cancer indications. So far, we have launched five therapies, and amassed plenty of successful commercialization experience. As we have strategically expanded our pipeline to now cover a variety of malignant cancers, including NSCLC, renal, breast and other malignant cancers to address large unmet medical needs of other patient populations. In June 2011, China's first small molecule anti-cancer drug for EGFR-targeted therapy which was developed independently by the company——Icotinib hydrochloride (trade name: Conmana®) was approved by the National Medical Products Administration (NMPA). Since its launch, more than 700,000 lung cancer patients have taken it.Conmana® has won the Gold Prize of China Patent Award twice as well as the China Industrial Award. It has also been awarded for the National Prize for Progress in Science and Technology, as the first such award granted to a China's chemical pharmaceutical industry and to a Zhejiang enterprise. In November 2020,Ensartinib hydrochloride capsule (trade name: Ensacove®), which is an innovative drug with independent intellectual property rights, that was jointly developed by Betta and its holding subsidiary Xcovery, was approved by NMPA. It became the first Category 1.1 new drug manufactured domestically in China for the treatment of advanced non-small cell lung cancer (NSCLC) with ALK mutations, which has filled the gap in the same class of drugs in China.In December 2024,Ensartinib was approved by the U.S. Food and Drug Administration, making it the first innovative small molecule lung cancer targeted drug led by a Chinese pharmaceutical company to be launched globally. In February 2025,Ensartinib officially initiated the new drug marketing approval process with the European Medicines Agency. In November 2021, the Bevacizumab injection jointly developed by Betta and Beijing Mabworks Biotechnology Co., Ltd. was officially approved for marketing, with approved indication is of metastatic colorectal cancer and advanced, metastatic or recurrent NSCLC. Bevacizumab became the company's first approved biological macromolecular drug. In May 2023, the third-generation EGFR-TKI Befotertinib (trade name: Surmana®) was approved for marketing. Surmana® is indicated for the treatment of patients with locally advanced or metastatic NSCLC with harboring acquired drug-resistant T790M mutation after first-generation EGFR-TKI treatment. The Lancet Respiratory Medicine commented that Surmana® as a novel candidate in the field of EGFR-mutant advanced NSCLC, can be considered as an alternative therapeutic choice for patients in China. In June 2023, Vorolanib, which is an innovative drug with independent intellectual property rights, was approved for marketing. It became the first National Class 1.1 new drug in China for the targeted treatment of renal cell carcinoma. The combination of Vorolanib and Everolimus could be the treatment of choice for patients with advanced RCC who progressed on TKI therapy. It is a significant milestone for the breakthrough of domestic innovative drugs in the field of renal cancer. Through independent R&D and strategic collaborations, Betta has extensively focused on lung cancer treatment products centered around EGFR and ALK targets. Simultaneously, it has advanced R&D in other mutation-related fields, further expanding into areas such as renal cancer, breast cancer, ophthalmology, and albumin-based therapies, thereby comprehensively broadening its business scope. The NDA for BPI-16350, intended for breast cancer treatment, has been officially accepted by NMPA, with relevant review and approval processes currently underway. With sustained investment and deep accumulation in innovation and R&D, Betta has constructed a pharmaceutical innovation ecosystem that effectively integrates resources from various stakeholders. Through partnerships with pharmaceutical funds and DreamWorks, it has engaged in in-depth strategic cooperation with promising companies, accelerating the translation of innovative drugs from laboratory research to clinical applications, thus expediting Betta's industrial layout and continuously expanding the boundaries of innovation. Looking ahead, Betta will proactively embrace the changes brought about by the times and technological advancements. Adhering to the development philosophy of "Better Medicine, Better Life," Betta will further promote the coordinated development strategy encompassing the "four pillars" of market sales, new drug R&D strategic cooperation, and the innovation ecosystem, striving to develop more affordable high-quality medicines for the general public.