Simcere Pharmaceutical : VOLUNTARY ANNOUNCEMENT IN RELATION TO THE APPROVAL OF PHASE III CLINICAL TRIAL APPLICATION FOR ADDITION OF NEW INDICATION FOR ENDOSTAR BY THE NATIONAL MEDICAL PRODUCTS ADMINISTRATION OF CHINA

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Simcere Pharmaceutical Group Limited

΋ᑊᖹุණྠϞࠢʮ̡

(Incorporated in Hong Kong with limited liability)

(Stock code: 2096)

VOLUNTARY ANNOUNCEMENT IN RELATION TO THE APPROVAL OF PHASE III CLINICAL TRIAL APPLICATION FOR ADDITION OF NEW INDICATION FOR ENDOSTAR® BY THE NATIONAL MEDICAL PRODUCTS ADMINISTRATION OF CHINA

This announcement is made by Simcere Pharmaceutical Group Limited (the "Company", together with its subsidiaries, the "Group") on a voluntary basis to inform shareholders and potential investors of the Company about the latest business advancement of the Group.

The board (the "Board") of directors (the "Director(s)") of the Company is pleased to announce that on March 19, 2021, the National Medical Products Administration of China has approved the phase III clinical trial application for addition of a new indication for Endostar® (recombinant human endostatin injection) ("Endostar®"). Pursuant to the approval, the Company plans to conduct a randomized, controlled and double-blinded multi-centre Phase III pivotal clinical study of intracavitary injection with recombinant human endostatin injection (Endostar®) in combination with Cisplatin versus Placebo in combination with Cisplatin for the treatment of malignant thoracoabdominal effusions.

The thoracoabdominal effusion is a common complication of malignant tumours, significantly affecting patients' quality of life and survival time. There is no standard of care for the intractable and refractory thoracoabdominal effusions and the prognosis of patients with these disease is poor.

The Expert Committee on Antitumor Medicine Safety Management (Ҥ໕ᆯᖹيτΌ၍ଣਖ਼ ࢕։ࡰึ) of the Chinese Society of Clinical Oncology and the Expert Committee on Vascular Targeted Therapy (А၍ཪΣطᐕਖ਼࢕։ࡰึ) of the Chinese Society of Clinical Oncology published the "Expert Consensus on the Clinical Application of Recombinant Human Vascular Endostatin for the Treatment of Serous Cavity Effusion" (the "Expert Consensus") in the Journal of Clinical Oncology in September 2020. The Expert Consensus provided a summary and analysis on translational research, clinical trials and real-world practical experience in applying Endostar® to treat serous cavity effusion. The Expert Consensus showed that Endostar® has a definitive efficacy in intracavitary perfusion therapy of serous cavity effusion, significantly inhibiting the production of effusions, alleviating the clinical symptoms involved, improving the patient's quality of life, helping prolong survival time, and it has a good safety and tolerability and is widely recognised in the clinical oncology community.

ABOUT ENDOSTAR®

Endostar®, the category I innovative biologic drug of the Company, is the first proprietary anti-angiogenic targeted drug in China and the only endostatin approved for sale in China and worldwide, according to Frost & Sullivan. It is also the first innovative biologics approved for sale in China as a first-line treatment for NSCLC. Recombinant human endostatin is a genetically engineered protein that inhibits the growth of blood vessels to a tumor, thereby slowing and preventing the growth and metastasis of tumor cells. Endostar® is a targeted cancer therapy drug which, in combination with NP chemotherapy regimen, can be used to treat early and recurrent stage III/IV NSCLC. The Company's phase III clinical trials, completed in 2004, demonstrated that, compared with NP chemotherapy regimen alone, combining Endostar® with NP chemotherapy regimen can significantly extend advanced NSCLC patients' median time to progression (TTP) and overall survival (OS) and improve their quality of life. The Company commenced its phase IV post-marketing clinical trials in 2006, enrolling an aggregate of 2,725 subjects. According to the Company's phase IV clinical trials, combining Endostar® with other different first-line chemotherapies, including NP regimen, gemcitabine/Cisplatin (GP) regimen, paclitaxel/carboplatin (TC) regimen and docetaxel and Cisplatin (DP) regimen, could all slow down disease progression in advanced NSCLC patients (median time to progression (TTP) of 7.6 months and median OS of 17.6 months) with a favorable safety profile. In addition, trial results did not demonstrate a significant difference in efficacy among the four groups of Endostar®-combined chemotherapy.

ABOUT THE COMPANY

The Company is a company engaged in the R&D, production and commercialization of pharmaceuticals with the national key laboratory of translational medicine and innovative pharmaceuticals. The Company has a diversified product portfolio in strategically focused therapeutic areas, including, (i) oncology (including cell therapy), (ii) central nervous system diseases and (iii) autoimmune diseases, with leading positions in their respective therapeutic segments and/or established track record. The Company continues to source innovative therapies globally and established extensive strategic partnership with several multinational companies.

By order of the Board

Simcere Pharmaceutical Group Limited

Mr. Ren Jinsheng

Chairman and executive Director

Hong Kong, March 21, 2021

As at the date of this announcement, the Board comprises Mr. REN Jinsheng as the Chairman and executive Director, Mr. ZHANG Cheng, Mr. WAN Yushan and Mr. TANG Renhong as the executive Directors; Mr. ZHAO John Huan as the non-executive Director; and Mr. SONG Ruilin, Mr. WANG Jianguo and Mr. WANG Xinhua as the independent non-executive Directors.