Proprietary SARS-CoV-2 3CL Inhibitor Rapidly Progressing in Clinical Trials, Market Approval of Trilaciclib Expected in China, Simcere Reveals Global Innovation Ambition on R&D Day

NANJING, China, April 18, 2022 /PRNewswire/ -- On April 15, 2022, Simcere Pharmaceutical (2096.HK), an innovation and R&D driven pharmaceutical company in China held its first R&D day for international investors, during which the executive leaders revealed Simere's R&D strategy, and gave an update on Simcere's pipeline to the global investment community.

Mr. REN Jinsheng, Chairman and CEO, Dr. TANG Renhong, Executive Vice President, Dr. Bijoyesh Mookerjee, Chief Medical Officer, Oncology, Mr. ZHOU Gaobo, Chief Investment Officer, Dr. Kevin Oliver, Senior Vice President, Dr. Danny Chen, Senior Vice President, Mr. Andrew Zhu, Senior Vice President, and Mr. BAO Jun, Board Secretary attended the meeting as speakers.

Highlights:

• First-in-class (FIC) novel myelo-protective drug Trilaciclib is expected to be launched in China in 2022. Targeting large Chinese patient population receiving chemotherapy, the product has the potential for delivering significant patient impact and commercial success.
• As a breakthrough product in China's stroke market, Sanbexin® achieved significant growth and contributed to the overall annual CNS business revenue of RMB 1.5 billion, highlighting Simcere's strong commercial capabilities. Rapid clinical development of Sanbexin sublingual tablets for sequential stroke treatment and other investigational new drugs is forming a multi-mechanism, full-course therapeutic approach to stroke which will further secure Simcere's leadership in this area.
• Proprietary oral SARS-CoV-2-3CL inhibitor co-developed by Simcere and the Shanghai Institute of Materia Medica (SIMM) of the Chinese Academy of Sciences is the first locally manufactured oral 3CL inhibitor approved for clinical trial in China. The first subject was enrolled in early April.
• Simcere's R&D pipeline consists of nearly 60 projects, with 20 projects in clinical stage, involving 17 potential innovative drugs.
• The company is seeking global expansion by actively exploring oversea licensing opportunities and planning for global multiple center clinical trials. The company is also actively hiring executive leaders with global experience and expanding its talent pool.

01 Successful transformation towards innovation that emphasizes on "effectiveness"

On the journey to build an innovation and R&D-driven pharmaceutical company, Simcere emphasizes "clinical differentiation and effectiveness". Simcere has marketed five innovative drugs in China and in 2021, the share of innovative products in total revenue reached 62.4%. Annual R&D investment was RMB 1.417 billion, accounting for 28.3% of total revenue.

Currently the company has an R&D pipeline of nearly 60 innovative projects. The two-pronged approach of Simcere's R&D, combining independent research with cooperative development, focuses on oncology, CNS and autoimmune diseases, with an eye on additional disease areas that may have significant clinical needs in the future.

Simcere's independent R&D technology platform has deployed multiple cutting-edge technology including immuno-oncology bispecific antibodies, multi-specific T cell engager, synthetic lethality molecules, AI drugs, Treg-Biased Fusion Proteins, and autoimmune antibody-drug conjugates (ADCs) etc. 6 projects independently developed by Simcere were presented at AACR annual meeting 2022, including two oral presentations. 10 new INDs are expected to be filed in China or in the United States, more than half of which are driven by in-house development.

In response to the major challenges of human health posed by COVID-19, Simcere is co-developing an oral anti-SARS-CoV-2 virus agent SIM0417 in collaboration with SIMM of the Chinese Academy of Sciences. It is the first proprietary anti-COVID 19 oral 3CL inhibitor developed locally in China that has been approved for clinical trial. The Phase I clinical study of the project has started subject enrollment in Qianfoshan Hospital of Shandong Province. According to the clinical plan, the Phase I clinical study will complete the dosing of all subjects by the end of May.

SIM0417 is highly selective and potent small molecule inhibitor of 3CL, a key enzyme in the replication and life cycle of coronaviruses, including SARS-CoV-2. Preclinical studies have demonstrated good antiviral activity and safety. Due to the 3CL protease's highly conserved nature, SIM0417 has a strong inhibitory effect on a variety of SARS-CoV-2 variants including wild type virus, Delta variant, and Omicron variant.

In face of the Omicron infection which is far more contagious but is less severe than the infection caused by wild type or Delta strains, Simcere is creatively designing Ph2/3 clinical study for wider target populations in a differentiated strategy compared with other products or investigational drugs on the similar target.

02 Oncology: Trilaciclib rapidly progressing towards market approval at "Simcere speed"

Simcere's oncology R&D strategy is to focus on highest unmet clinical needs, explore opportunities of first and best in class medicines, and deliver new assets and combinations. The company's oncology pipeline covers lung cancer, breast cancer, digestive tract tumors, gynecological tumors, glioma etc., with novel MOAs and differentiated development strategies, such as IO checkpoint inhibitor that can be administered subcutaneously (Envafolimab), short-acting CDK4/6 cell cycle inhibitor (Trilaciclib), monoclonal antibody acting on IO novel target TNFR2 (SIM0235), and blood-brain barrier permeable BIC oral SERD compound (SIM0270).

Trilaciclib (COSELA) jointly developed by Simcere and G1 Therapeutics has initiated phase III clinical trials in China for the treatment of extensive-stage small cell lung cancer (ES-SCLC), colorectal cancer, and triple-negative breast cancer. The registration study of ES-SCLC has reached the primary end point, which further validates the safety and myelo-protective efficacy of trilaciclib, on granulocytes, platelets and red blood cell lines in the Chinese population.

The NDA for the first indication (small cell lung cancer) submitted in China has been included in priority review by the CDE. It is expected to be approved in the latter half of 2022. Simcere spent only 10 months from IND to NDA submission in China, demonstrating high efficiency in clinical development. Targeting large Chinese patient population receiving chemotherapy, the product has the potential for delivering significant patient impact and commercial success.

The submission was additionally supported by Real Word Study evidence in Hainan where Chinese patients can receive drugs approved by FDA or EMA prior to approval in China. 30 patients were enrolled from June to November in 2021 and data analyzed will be complete in 2022.

03 CNS: Multi-mechanism approach to secure leadership in stroke, with Sanbexin® as core product

Stroke, a disease causing 3.3 million new cases in China annually, is the major CNS illness with huge clinical needs. Simcere has been deeply involved in the field of stroke treatment for decades. Sanbexin® independently developed by Simcere is the only new stroke drug approved for market in the world since 2015. The product achieved market excellence and has helped over 600,000 Chinese patients within its first year of launch.

Positive results from the pivotal Phase III study (TASTE study) of Sanbexin® for acute ischemic stroke (AIS) were published in the journal STROKE in 2021. Subject enrollment in phase IV study (TASTE II study) of Sanbexin® combined with vascular recanalization therapy began in March 2022. Clinical exploration of Sanbexin® in hemorrhagic stroke is expected to be launched in June.

Phase III registration study of Sanbexin sublingual tablet has nearly completed all subject enrollment, with topline clinical data expected within 2022. The sequential treatment of Sanbexin oral plus injection dosage form will likely cover the entire course of ischemic/hemorrhagic stroke, and enable patients to receive timely and complete treatment.

Furthermore, Simcere will secure its leadership in stroke in China by forming a combination of multiple mechanism assets, including SIM0307, an AQP 4 inhibitor for brain edema at Phase I clinical trials in China, and the regional licensing of AVLX-144, an innovative drug for acute ischemic stroke targeting the postsynaptic scaffold protein PSD-95.

In addition, Simcere entered Alzheimer's disease (AD) field through partnering with Vivoryon. The oral small molecule SIM0408 can inhibit the production of neurotoxic N3pE amyloid, which plays a role in the pathology of early stages of AD. It has received IND approval in China and may bring more effective medication to millions of Chinese suffering from the cureless disease.

04 Go global, reach new height

The preliminary success of Simcere's transformation towards innovation is followed by further efforts of globalization in terms of project licensing, investment, R&D, and talents.

The BD team of Simcere is geographically established in China, the United States, Canada, the United Kingdom, Germany, etc., with high credibility, diversified backgrounds and deep reputation in the industry.

Aiming at becoming 'Partner of Choice', Simcere values its existing 35+ alliances and LP positions globally. Since 2021, more than 8 licensing partnerships were made globally to introduce innovative assets. Simcere also strategically participated in a number of overseas life science investment funds, and is thereby closely associated with the world's most active innovation communities.

Multiple in-licensed products have achieved impressively fast progress in clinical study in China soon after the deals were made, including Trilaciclib, a short-acting CDK4/6 inhibitor, SIM0307 a molecule with Nobel winning mechanism to address cerebral edema, and SIM0408 a novel Alzhermer's disease therapy etc. In 2022, the newly achieved deal on a highly selective JAK 1 inhibitor is expected to bring another blockbuster for autoimmune diseases. Simcere is also exploring out-licensing opportunities and is expected to realize oversea authorization of a self-developed product within this year.

In terms of R&D internationalization, Simcere has established 4 innovation centers in China and the United States to explore the global development mode of innovative drugs. The TNFR2 antibody developed by Simcere has received IND approval in both China and the United States. The anti-COVID 19 oral 3CL inhibitor is also expected to start clinical trials overseas soon. In 2022, 3 new INDs of in house developed projects may be submitted in the United States.

Simcere also is building a team of leading talents with global perspective and backgrounds. Among the speakers at the R&D day, Mr. Zhou Gaobo, Chief Investment Officer, Dr. Bijoyesh Mookerjee, Chief Scientific Officer of Oncology, Dr. Danny Chen, Senior Vice President and Mr. Andrew Zhu, Senior Vice President who recently joined Simcere all hold decades of academic/professional experience in large multinational companies. They will bring great help to Simcere's innovation and globalization. Meanwhile, Simcere's X plan launched by the State Key Laboratory, targets 10 important life sciences fields and is further attracting outstanding talents and R&D projects from major universities and research institutes around the world.

SOURCE Simcere Pharmaceutical Group Limited