Milestone! Anti-new crown innovative drug candidate Synoxin? (SIM0417) completed all patient enrollment

On December 18, Simcere Pharmaceutical (2096.
HK) announced on the Hong Kong Stock Exchange that the Company's innovative anti-novel coronavirus (SARS-CoV-2) drug candidate ™ in collaboration with the Shanghai Institute of Materia Medica, Chinese Academy of Sciences and the Wuhan Institute of Virology has made significant progress in the phase: a multicenter, randomized, double-blind, placebo-controlled phase II/III clinical study (the "study") to evaluate the efficacy and safety of Sinohin ™ in the treatment of adults infected with mild to moderate COVID-19 (novel coronavirus pneumonia) All 1208 patients have been enrolled
.

Synoxin ™ is a combination packaging drug of 3CL protease anti-new crown innovative drug candidate and ritonavir that is necessary for SARS-CoV-2 virus replication
.
In preclinical trials, Synoxin ™ showed highly potent, broad-spectrum anti-coronavirus activity
.
On November 17, 2021, the Group entered into a technology transfer contract with the Shanghai Institute of Materia Medica, Chinese Academy of Sciences and the Wuhan Institute of Virology, pursuant to which the Group obtained the exclusive right
to develop, manufacture and commercialize the 3CL protease inhibitor Synoxin ™ globally.

On March 28 and May 13, 2022, Sinoxin ™ received two drug clinical trial approval notices issued by the National Medical Products Administration (NMPA) for the treatment of mild to moderate COVID-19 infections and post-exposure prophylaxis for close contacts of people who have been exposed to SARS-CoV-2 positive infections
.

Simcere Pharmaceutical will accelerate the analysis of clinical research results, actively prepare new drug marketing applications, and accelerate the expansion of production capacity to meet urgent clinical needs, and fulfill Simcere's corporate mission
of "allowing patients to use more effective drugs as soon as possible".

The study, led by Academician Wang Chen of the Chinese Academy of Medical Sciences, National Center for Respiratory Medicine and Professor Cao Bin, Vice President of China-Japan Friendship Hospital, is the first clinical study
to enter the registered phase III trial and complete the total number of planned cases for Chinese patients infected with the new crown Omicron strain at home and abroad.
In this study, clinical endpoints were designed in accordance with internationally accepted standards, and a total of 43 clinical research centers
were established in 20 provinces, municipalities and autonomous regions in China.
Since the first patient enrollment was achieved on August 19, 2022, all 1208 patients were enrolled
within four months.
The clinical dosing regimen was Sinohin ™ versus placebo for 5 consecutive days, and the study endpoints included time to recovery of COVID-19 symptoms, viral load reduction, etc
.

Since the liberalization of domestic epidemic prevention and control policies, the number of new crown infections has increased sharply, posing a serious threat
to the lives and health of vulnerable people with underlying diseases and severe disease risk factors.
The early launch of a safe, effective and highly accessible domestic anti-new crown virus specific drug is the urgent expectation of the general public, and it is also a scientific and technological weapon
urgently needed for national epidemic prevention and control.
On November 17, 2021, Simcere Pharmaceutical, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, and Wuhan Institute of Virology completed the cooperation agreement, and the clinical research and development work of Simcere ™ launched a race against time
.

"The new crown seriously endangers people's health, and the research and development of an effective anti-new crown innovative drug is of special significance for controlling the harm of the new crown epidemic, reducing fear and reducing the mortality rate, and clinical experts and biomedical companies should make unremitting efforts
to this end.
" During the difficult period of Sinoxin's ™ research and development, the leading scientist Academician Wang Chen held a meeting to stimulate the confidence and sense of mission of
front-line clinical researchers in the fight against the epidemic.

"At the moment when the Synoxin ™ Project has achieved a major milestone, we would like to thank the Phase I clinical center of the Synoxin ™ Project, Shandong Qianfoshan Hospital, Shenzhen Third People's Hospital, Fudan Zhongshan Hospital, Phase II Clinical Center, and hundreds of respectable researchers from 43 Phase III Clinical Centers, including China-Japan Friendship Hospital, Shenzhen Third People's Hospital, Wuhan Jinyintan Hospital, and Hainan Sanya Central Hospital, for their hard work and outstanding contributions!" Dr.
Tang Renhong, Executive Director of Simcere Pharmaceutical, said
.

In the research and development process of Synoxin for more than a year, the state and government agencies in many places across the country have given strong support
to Synoxin's ™ ™ R&D.
The project entered the key scientific research project
of the joint prevention and control mechanism of the State Council.
The State Food and Drug Administration, Hainan Provincial Government and Jiangsu Provincial Government attach great importance to the drug evaluation center of the State Food and Drug Administration, the Health Commission of Hainan Province and Jiangsu Province, and the drug regulatory departments to provide timely and careful guidance and professional support
for the development of clinical research and the promotion of review and approval.
Nanjing Jiangbei New Area and Haikou Municipal Government provide a series of strong policy guarantees
for the rapid expansion of production capacity of the project.

The just-concluded Central Economic Work Conference called for focusing on the prevention and control of the elderly and groups suffering from basic diseases, and focusing on maintaining health and preventing serious diseases
.
This has pointed out the direction for the current research and development of innovative drugs to fight the new crown, and we feel a great
responsibility.
After making the current important progress, Simcere Pharmaceutical will continue to keep in mind its mission, make every effort to "let patients use more effective drugs as soon as possible", and contribute to the national anti-epidemic strategy of "maintaining health and preventing severe disease" in the later stage!