SHANGHAI, China, December 23, 2022 - Ping An-Shionogi Co., Ltd. (Head Office: Shanghai, China; Chairman and CEO: Tatsumori Yoshida, hereafter "Ping An-Shionogi") today announced signing of a license agreement with Shanghai Pharmaceutical Co., Ltd (Head Office: Shanghai, China; General Manager and Director: Yongzhong Li; hereafter "SHAPHAR"), a subsidiary of Shanghai Pharmaceuticals Holding Co., Ltd. (Head Office: Shanghai, China; Executive Director and President: Man Cho; hereafter "SPH") for import and distribution of Ensitrelvir (development number: S-217622), a therapeutic drug for COVID-19, in mainland China.
Ping An-Shionogi is developing its business to provide the better health and quality of life to the people in China by delivering a variety of healthcare solutions including new healthcare services, high-quality generic drugs, and new drugs discovered in its parent company, Shionogi Co., Ltd. SPH is a large pharmaceutical group with dual listings on the Shanghai and Hong Kong’s stock exchanges. The company’s core business is in pharmaceuticals and covers four major activities: Research & Development, Manufacturing, Distribution and Retailing. SHAPHAR, a subsidiary of Shanghai Pharmaceuticals Holding Co., Ltd., is a modern provider of pharmaceutical supply chain services that focuses on pharmaceutical distribution. Relying on a distribution network covers more than 30,000 medical institution terminals nationwide and strong service innovation，SHAPHAR has taken a leading position in the industry.
Ping An-Shionogi has already started to submit materials to the Center for Drug Evaluation ("CDE") of the National Medical Products Administration of China ("NMPA") in preparation for the new drug application for Ensitrelvir. Ping An-Shionogi is continuing close communication with the CDE, following the approval of Ensitrelvir in Japan on November 22, 2022. According to this license agreement for the import and distribution of Ensitrelvir, SHAPHAR will exclusively import Ensitrelvir into China and deliver it after the approval. Both companies will cooperate to contribute to COVID-19 treatment in China by providing a stable supply of Ensitrelvir as soon as possible.
With the conclusion of this agreement, Ping An-Shionogi and SPH also started to explore various collaboration opportunities in the future, including the import, distribution, and manufacture of new drugs, and expansion of the sales network and improvement of market coverage of generic drugs. Both companies will continue to discuss how to provide the better healthcare services synergistically to the people living in China.
About Ensitrelvir
Ensitrelvir, an antiviral drug for COVID-19 currently approved under the emergency regulatory approval system in Japan, is a 3CL protease inhibitor created through joint research between Hokkaido University and Shionogi. SARS-CoV-2 has an enzyme called 3CL protease, which is essential for the replication of the virus. Ensitrelvir suppresses the replication of SARS-CoV-2 by selectively inhibiting 3CL protease. Ensitrelvir is the first antiviral agent to show both clinical symptomatic efficacy for five typical Omicron-related symptoms (primary endpoint) and antiviral efficacy (key secondary endpoint) in patients with mild to moderate SARS-CoV-2 infection, regardless of risk factors or vaccination status, in the Phase 3 part of the Phase 2/3 study conducted during the Omicron-dominant phase of the epidemic 3. Currently, the Phase 2b/3 part of the Phase 2/3 study targeting SARS-CoV-2 infected persons with asymptomatic/mild symptoms only is being conducted in Asia, mainly in Japan. With regard to safety, Ensitrelvir was well tolerated, and there were no treatment-related serious adverse events or deaths in the study. The most common treatment-related adverse events were transient decreases in high-density lipoprotein and increases in blood triglycerides, as observed in previous studies. A global Phase 3 trial (SCORPIO-HR study) in non-hospitalized SARS-CoV-2 infected patients is ongoing. In addition, a global Phase 3 trial (STRIVE study) for hospitalized SARS-CoV-2 infected patients is scheduled to initiate soon. An onset prevention study for household members living with SARS-CoV-2 infected individuals and a pediatric study for children under the age of 12 are also in preparation.
Reference
- Press Release on July 4, 2022
Ping An-Shionogi Initiates the Submission of the Preparation Materials for New Drug Application for S-217622, a Therapeutic Drug for COVID-19, in China - Press Release on November 23, 2022
Shionogi Announces Xocova® (Ensitrelvir Fumaric Acid) Tablets 125mg Approved in Japan for the Treatment of SARS-CoV-2 Infection, under the Emergency Regulatory Approval System - Press Release on September 29, 2022
Shionogi Announces Achievement of the Primary Endpoint for Ensitrelvir Fumaric Acid (S-217622) in the Phase 3 part of the Phase 2/3 Clinical Trial in Asia
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