Recently, at the first World-Benefiting Pharmaceutical Innovation Award ceremony, founder, president & CEO of Akesobio, Dr. Xia Yu was awarded as “Top 10 Pharmaceutical Innovation Leader of the Year”, co-founder & senior vice president of Akesobio, Dr. Wang Zhongmin was awarded as “Top 10 Pharmaceutical Innovation Scientist of the Year”.
This event and award are organized and polled by listed companies’ information disclosure media Securities Times designated by the CSRC (China Securities Regulatory Commission). By appraising and having chosen the outstanding projects, companies and people of pharmaceutical innovation in China, the award aims to promote pharmaceutical innovation and the high-quality development of pharma industry.
As one of the representatives of Chinese biopharma innovation companies in new era, in the lead of the four founding scientists - Dr. Xia Yu, Dr. Li Baiyong, Dr. Wang Zhongmin and Dr. Zhang Peng, Akesobio’s biopharma innovation platform and system capability, which was established with years of efforts, has continued to grow, the company’s drug research and development has also entered “harvest time”.
In 2020, the PD-1 monoclonal antibody novel drug Penpulimab (AK105), which Akesobio co-developed with Sino Biopharmaceutical Limited (stock code: 1177. HK), has successfully submitted NDA for the treatment of relapsed or refractory classical Hodgkin’s lymphoma. In the same year, Penpulimab obtained breakthrough therapy designation, orphan drug designation and fast track designation from the Food and Drug Administration of the United States (FDA) for third-line treatment of patients with metastatic nasopharyngeal carcinoma. Currently, Penpulimab has submitted a Biologics License Application (BLA) to the FDA for third-line treatment of metastatic nasopharyngeal carcinoma under the new policy of Real-Time Oncology Review (RTOR).
What worth mentioning is that, in 2020, the company’s self-developed globally first-in-class PD-1/CTLA-4 bispecific antibody drug Cadonilimab (AK104) clinical trial for treating patients with recurrent or metastatic cervical cancer has completed patient enrollment and obtained the “Breakthrough Therapy Designation” from the National Medical Products Administration (NMPA) of China, obtained orphan drug designation and fast track designation from the FDA. Akesobio has also obtained approval from the NMPA to initiate the Cadonilimab phase III clinical trial for first-line treatment of unresectable locally advanced or metastatic gastric cancer in combination with chemotherapy. At present, there are 9 clinical trials at Phase II or later stage for Cadonilimab in treating lung cancer, liver cancer, cervical cancer, gastric cancer, and nasopharyngeal carcinoma, etc.
Meanwhile, Akesobio has in total over 40 clinical trials efficiently in progress world-wide, among which 9 clinical trials are at registrational or phase III stage and 4 registrational trials have reached key endpoints.
Keeping a high R&D innovation development efficiency in 2021, Akesobio expects that the new drug application for Penpulimab for treatment of patients with classical Hodgkin’s lymphoma that has relapsed or refractory after second or more systemic chemotherapy will be approved this year. The company also expect to submit the new drug application for Cadonilimab for treatment of recurrent or metastatic cervical cancer in 2021, Cadonilimab is expected to become the the first PD-1 based bispecific antibody drug worldwide, leading the immuno-oncology era 2.0. In the meantime, the new drug application for Penpulimab for third-line treatment of nasopharyngeal cancer and for first-line treatment of squamous non-small
cell lung cancer will also be submitted in 2021.