27% year-over-year revenue growth, with innovative medicines accounting for 65.4% of total revenue

NANJING, China, September 5, 2022 /PRNewswire/ — Simcere Pharmaceutical Group Limited (2096.HK) announced its financial results for the first half of 2022. June 30thSimcere recorded operating revenues of 2.7 billion RMB for the first half of the year, with year-over-year growth of 27.3%. The estimated net profit for the first half of 2022 after deducting non-recurring profits and losses would be 390 million RMB. Revenues from innovative medicines increased 44.8% year-on-year to reach 1.767 billion RMB, representing a record 65.4% of total revenue. Simcere has transformed into an innovative pharmaceutical company that relies on innovation and R&D to drive performance.

According to the report, Simcere Pharmaceutical currently has 6 branded innovative pharmaceutical products in the market. In the two years since its launch, Sanbexin® (Edaravone and Dexborneol Concentrate Solution for Injection), Simcere’s innovative stroke medicine, benefited 860,000 patients nationwide, driving revenue growth of 74.7% year-over-year from CNS portfolio and further enhancing Simcere’s market leadership position in this area. Additionally, revenue contribution from products such as Enweida® (envafolimab injection), the world’s first subcutaneous PD-(L)1 antibody, further validated Simcere’s commercial capabilities.

Under the R&D strategy of “focusing on more effective therapies and emphasizing differentiation”, the company is currently accelerating nearly 60 innovative drug pipeline projects and conducting 20 out of 16 registered clinical studies. potential innovative drugs. 7 projects have entered phase 3 clinical trials, including 2 highlighted candidates, Sanbexin sublingual tablets and SIM0417, an investigational anti-SARS-CoV-2 drug.

Sanbexin sublingual tablets (oral formulation of Edaravone and Dexborneol), an innovative drug currently under development in a Phase 3 clinical study, provides anti-inflammatory and anti-free radical effects as well as protection of the blood-brain barrier to minimize damage to brain cells caused by stroke. The administration of the sublingual tablet is not limited by the capabilities of the medical institution or the compliance of the patient, which makes it suitable for various conditions of acute or chronic CNS disease. It is planned to form a sequential diet with Sanbexin® injection. Currently, patient enrollment of 914 subjects has been completed for the product’s pivotal Phase 3 trial just 10 months ahead of schedule. Simcere will accelerate its NDA by China Short term. Market analysis revealed that the drug would quickly peak in sales after hitting the market due to Simcere Pharmaceutical’s long-standing CNS market share. The paucity of innovative CNS drugs in China also increases the investment value of Simcere.

SIM0417, another important product developed by Simcere, is an anti-SARS-CoV-2 candidate that targets 3CL, a key protease essential for virus replication, and has shown good antiviral activity against a variety of strains. Preclinical studies have shown that certain measures of efficacy and safety of SIM0417 are better than those of molecules with similar biological targets currently on the market. As of the date of the announcement, Simcere Pharmaceutical was conducting two Phase 2/3 clinical trials of SIM0417 plus ritonavir versus placebo for antiviral treatment in COVID-19 patients and for post-exposure prophylaxis for contacts. contacts of people who tested positive for COVID-19. 19 in several provinces and cities according to the CDE (Center for Drug Evaluation) approved clinical trial protocol. During the persistent epidemic and recurrent epidemics, there is a significant unmet need for prevention and treatment of close contacts of COVID-19. As a small molecule drug and oral tablet, SIM0417 has inherent advantages in responding to the pandemic due to its convenience in storage, transport and administration.

Through Simcere’s efforts combining in-house R&D with extensive R&D collaborations, business development has contributed immensely to the company’s pipeline. On July 12, 2022Simcere has received conditional approval for its first-in-class innovative drug Cosela® (trilaciclib hydrochloride for injection), developed under license – in collaboration. Cosella® is the world’s first myeloprotective drug that prevents damage to bone marrow stem cells caused by cytotoxic chemotherapy. The successful development of this drug took only 708 days from the date of signing the licensing agreement to market approval in China. According to published industry data, among the top 100 licensed products in China between 2019 and 2021 in terms of transaction amount, only 4 products are approved with new indications on the Chinese market. In this list, Trilaciclib takes the first place for rapid development in Chinaalmost shortens the time frame by one year compared to the second-ranked product.

As one of the first pharmaceutical companies in the industry to complete its innovation transformation, the advantages of Simcere’s differentiated R&D capabilities, manufacturing capabilities compared to international measurements, and industry-leading commercial capabilities are gradually emerging. Innovative drug R&D pipelines began to bear fruit, allowing Simcere to more efficiently and successfully launch more differentiated innovative drugs while expanding its commercial capabilities.

Since the successful IPO on the Hong Kong Stock Exchange in 2020, Simcere Pharmaceutical’s innovative medicines business has become a major driver of the company’s continued growth. According to the outlook section of the announcement, Simcere will accelerate its R&D process on Sanbexin sublingual tablets to complete its pivotal Phase 3 clinical trials, actively explore possible new indications for Cosela, and accelerate R&D of the anti-SARS drug- CoV-2 SIM0417.

While the national bulk purchasing program is having a big impact on the pharmaceutical industry, Chinese companies are focusing on differentiated innovation. Simcere chooses a unique approach to innovation based on its continuous investments in R&D, its diversified and differentiated pipelines and its proven commercial capabilities. These efforts will provide a driving force for future growth and development.

About Simcere

Simcere Pharmaceutical Group Limited (2096.HK) is a pharmaceutical company driven by innovative R&D and committed to synergistic innovation. It established the State Key Laboratory for Translational Medicine and Innovative Drug Development and currently has four R&D centers in Nankeen, Shanghai, Boston and beijing. With a commitment to “provide the patients of today with the medicines of the future”, the Company is focused on three therapeutic areas: oncology, central nervous system diseases and autoimmune diseases, while actively expanding its strategic presence in potential disease areas with significant clinical needs in the future.

Simcere now has six first-class innovative drugs in the world and holds leading market shares for its key products in China with its excellent R&D and marketing capabilities. Its vigorous in-house R&D efforts and extensive R&D collaborations have made it a strategic cooperation partner with leading international and domestic innovative pharmaceutical companies, medical institutions and research institutes.

SOURCESimcere Pharmaceutical Group Limited

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