Lee’s Pharmaceutical Announces Its Anti-PD-L1 Antibody Socazolimab, Licensed From Sorrento Therapeutics, Receives Breakthrough Therapy Designation in China for the Treatment of Recurrent or Metastatic Cervical Cancer

• Socazolimab is an anti-PD-L1 antibody licensed from Sorrento for the Greater China Territory by Lee’s Pharma.
• China National Medical Products Administration (NMPA) grants breakthrough Therapy Designation (BTD) to socazolimab for the cervical cancer indication.
• Lee’s Pharma plans to file new drug application in China in Q2 2021.
• Sorrento congratulates Lee’s Pharma on advancing clinical development of socazolimab.
• Lee’s Pharma and Sorrento are entering expanded partnership discussions for the license of additional therapeutic antibodies from Sorrento’s G-MAB library.
  

HONG KONG and SAN DIEGO, Feb. 09, 2021 (GLOBE NEWSWIRE) -- China Oncology Focus Limited (COF), an affiliate of Lee's Pharmaceutical Holdings Limited (Lee's Pharma, HKEX: 950), and Sorrento Therapeutics, Inc. (Sorrento, Nasdaq: SRNE), today announced that its anti-PD-L1 antibody, socazolimab, licensed from Sorrento to COF for the greater China territory, has been granted breakthrough therapy designation (BTD) by the China National Medical Products Administration (NMPA) to treat recurrent or metastatic cervical cancer.

The NMPA established its BTD program in July 2020 to facilitate the research and development of innovative drugs that treat severe life-threatening or quality-of-life impairing diseases with no existing therapy or with proven evidence to demonstrate clear clinical benefits as compared to existing therapies. Products with BTD from the NMPA may be considered for conditional approval and priority review when submitting a New Drug Application (NDA).

“China NMPA granted socazolimab breakthrough therapy designation in recognition of both significant unmet medical need and positive and promising clinical results of socazolimab treatment for patients with recurrent or metastatic cervical cancer,” said Dr. Benjamin Li Xiaoyi, Chief Executive Officer of Lee’s Pharma. “Cervical cancer is the fourth most lethal cancer in women worldwide and the third cause of cancer-related death in developing countries. There is currently no recommended standard of care treatment for this disease in China. Socazolimab has the potential to be the leading anti-PD-L1 antibody in the treatment of this indication. Socazolimab has demonstrated outstanding efficacy and safety profile in the clinical trials so far in treating cervical cancer patients.”