SHANGHAI, China, December 29th, 2022 - Ping An-Shionogi Co., Ltd. (Head Office: Shanghai; Chairman and CEO: Tatsumori Yoshida, hereafter "Ping An-Shionogi") today announced signing of a promotion agreement with Chia Tai Tianqing Pharmaceutical Group, Co., Ltd. (Head Office: Jiangsu Province, President; Eric Tse, hereafter "CTTQ"), subsidiary of Sino Biopharmaceutical Limited (Head Office: Hong Kong; President: Theresa Tse; hereafter "Sino Bio"), a group company of CP Group, for promotion of Ensitrelvir (development number: S-217622), a therapeutic drug for COVID-19, in mainland China.
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. For the import and domestic distribution of Ensitrelvir, an agreement was already signed on December 23, 2022, with Shanghai Pharmaceutical Co., Ltd. Based on this agreement, Ping An-Shionogi will promote at some medical institutions, while CTTQ will exclusively promote Ensitrelvir at other institutions by utilizing its extensive sales network in China. Ping An-Shionogi will also collaborate in the promotion of Ensitrelvir at the facilities where Ping An-Shionogi conducts promotional activities. Ping An-Shionogi will promote collaboration with partner companies including CTTQ to contribute to COVID-19 treatment in China by providing Ensitrelvir as soon as possible.
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.
About CP group
Founded in Thailand in 1921 by Yee Chu, Tse, it is now a corporate group running diverse businesses including three core businesses; agriculture and food, wholesale and retail, and telecommunications and television, as well as finance, real estate, pharmaceuticals, and machinery processing, and so on. such as finance, real estate, pharmaceuticals, and machining, in over 100 countries and regions and is known in Thailand as the Charoen Pokphand (CP) Group. It is one of the largest foreign-owned companies in China, with more than 600 companies in the country, employing approximately 100,000 people.
About Sino Bio
A company responsible for the pharmaceutical business of the CP group, and was listed in Hong Kong Stock Exchange in 2000. It is one of China's leading pharmaceutical companies with therapeutic areas including liver disease, oncology, orthopedics, infectious diseases, respiratory and cardiovascular diseases, with sales exceeding RMB 26.8 billion in 2021.
About CTTQ
As the core pharmaceutical company in the CP Group, it runs integrated pharmaceutical research, development, manufacturing, and marketing, with more than 14,000 employees. The company has product lines for respiratory and infectious diseases as well as oncology, liver, endocrine, and cardiovascular diseases, and more than 7,000 academic and sales staff provide information on pharmaceutical products.
About Ping An-Shionogi
Founded in 2020, 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.
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 December 23, 2022
Ping An-Shionogi Signs a License Agreement for Import and Domestic Distribution of Ensitrelvir, a Therapeutic Drug for COVID-19 - 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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