On September 5, 2022 Simcere Pharmaceutical Group Limited (2096.HK) reported its financial results for the first half of 2022 (Press release, Jiangsu Simcere Pharmaceutical Company, SEP 5, 2022, View Source [SID1234619005]). As of June 30, Simcere recorded operating revenue of RMB 2.7 billion for the first half of the year, with a 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 RMB 390 million. Innovative drug revenue grew 44.8% year-over-year to RMB 1.767 billion, accounting for a record-high 65.4% of total revenue. Simcere has transformed into an innovative pharmaceutical company that relies on innovation and R&D for performance growth.
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According to the report, Simcere Pharmaceutical currently has 6 branded innovative drug products on the market. In the two years since its launch, Sanbexin (Edaravone and Dexborneol concentrated solution for injection), Simcere’s innovative drug for stroke, has benefited 860,000 patients nation-wide, driving a 74.7% year-over-year revenue growth of the CNS portfolio and further improving Simcere’s leading market position in this field. Moreover, revenue contribution from products such as Enweida (Envafolimab injection), the world’s first subcutaneous PD-(L) 1 antibody, further validated Simcere’s business capabilities.
Under the R&D strategy of "focusing on more effective therapies and emphasizing differentiation", the company is currently fast-tracking nearly 60 innovative drug pipeline projects and conducting 20 registered clinical studies on 16 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.
The Sanbexin sublingual tablets (oral formulation of Edaravone and Dexborneol), an innovative drug currently being developed at phase 3 clinical study, offers anti-inflammatory and anti-free radical effects together with blood-brain barrier protection to minimize brain cell damage caused by stroke. The administration of sublingual tablet is not restricted by medical institution capabilities or patient compliance, making it suitable for various conditions of acute or chronic CNS diseases. It is expected to form a sequential regimen with Sanbexin injection. At present, patient enrollment of 914 subjects have been completed for the product’s pivotal Phase 3 trial within just 10 months ahead of schedule. Simcere is going to expedite its NDA in China in the near term. Market analysis revealed that the drug would quickly achieve peak sales after reaching the market owing to Simcere Pharmaceutical’s long-standing CNS market share. The scarcity of innovative CNS drugs in China also increases Simcere’s investment value.
SIM0417, another important product being 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 some of the SIM0417 efficacy and safety metrics are better than those of molecules having similar biological targets currently on the market. As of the announcement date, Simcere Pharmaceutical has been conducting two Phase2/3 clinical trials of SIM0417 combined with Ritonavir versus placebo for antiviral treatment in COVID-19 patients, and for post-exposure prophylaxis for close contacts of individuals who test positive for COVID-19 throughout several provinces and cities in accordance with the clinical trial protocol approved by CDE(Center for Drug Evaluation). During the persistent epidemic and recurrent outbreaks, there is a significant unmet need for the prevention and treatment of COVID-19 close contacts. As a small molecule drug and oral tablet, SIM0417 has inherent advantages in responding to the pandemic due to its convenience in storage, transportation, and administration.
As a result of Simcere’s efforts combining in-house R&D with extensive R&D collaborations, the business development has contributed tremendously to the company’s pipeline. On July 12, 2022, Simcere received conditioned approval for its first-in-class innovative drug Cosela (Trilaciclib hydrochloride for injection), developed through licensing–in collaboration. Cosela is the world’s first myelo-protection drug that prevents damage of bone marrow stem cells from cytotoxic chemotherapy. The successful development of this drug took only 708 days from the date of license-in agreement signing till market approval in China. According to published industrial data, among the top 100 license-in 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 fast development in China, nearly shortens the time frame by a year compared to the product ranked second.
As one of the first pharmaceutical companies in the industry to complete innovation transformation, the advantages of Simcere’s differentiated R&D capabilities, manufacturing capacities benchmarked against international metrics, and leading business capabilities, are gradually emerging. The innovative drug R&D pipelines have started to pay off, allowing Simcere to launch more differentiated innovative drugs more efficiently and successfully while expanding its business capabilities.
Since the successful IPO on the Hong Kong Stock Exchange in 2020, Simcere Pharmaceutical’s innovative drug business has become a major driver for the company’s continued growth. According to the outlook section in the announcement, Simcere will fast-track its Sanbexin sublingual tablet R&D process to complete its pivotal phase 3 clinical trials, actively explore possible new indications of Cosela, and expedite the R&D of anti-SARS-CoV-2 drug SIM0417.
As the national bulk-buy program bringing heavy impact to the pharmaceutical industry, Chinse companies are turning their focused on differentiated innovation. Simcere chooses a unique approach to innovation based on its continuous R&D investment, diversified and differentiated pipelines, and proven business capabilities. These efforts will provide driven force for future growth and development.