Simcere Oncology Secures RMB 970 Million in Funding to Accelerate Innovative Oncology Pipeline

2024Year2Month24Day, XianVoicePharmaceutical Company Issues Announcement,itsSubsidiary Simcere Zaiming will complete9.7RMB 100 million in financing. The pre-money valuation for this round of financing75100 million yuan, post-money valuation84.7RMB 100 million. SDIC Merchants (Advanced Manufacturing) led the investment8100 million yuan, Zhongshen Xinchuang Investment1100 million yuan, invested by Apricot Capital500010,000 yuan, Zhonghe Capital Investment200010,000 yuan.

Simcere Zaiming is a biopharmaceutical company under the Simcere Pharmaceutical Group, dedicated to the research and development, manufacturing, and commercialization of innovative oncology drugs. Established in December 2020 and operating independently since 2023, it is committed to addressing the substantial unmet clinical needs in the oncology field in China and globally through breakthrough therapeutic approaches.

Simcere Zaiming’s R&D strategy focuses on core therapeutic areas including lung cancer, gastrointestinal tumors, and gynecological cancers, with a mechanistic emphasis on tumor immunity, cancer driver genes, and synthetic lethality. In terms of drug modalities, Simcere Zaiming has established a portfolio encompassing protein engineering, T-cell engagers, NK-cell engagers, AI-assisted molecular design, protein degraders, and antibody-drug conjugates (ADCs).

Simcere Zaiming is committed to building a high-value innovative R&D pipeline. Its marketed product portfolio includes three global innovative drugs—Cosela®, Envafolimab®, and Endostar®—which are driving a trajectory of rapid revenue growth.

Among them, Endostar is an established drug whose unit price has declined year by year since its inclusion in the national medical insurance catalog, leading to a gradual decrease in its revenue-generating capacity. Therefore, future growth in the oncology business will primarily come from Envafolimab and Cosela, both of which were launched in the past two years.

Envafolimab was approved for marketing in November 2021, becoming the world’s first subcutaneously injectable PD-L1 inhibitor. In contrast, other PD-1 inhibitors are administered intravenously. Thanks to its unique route of administration, Envafolimab offers advantages such as shorter administration time and a favorable safety profile. Simcere holds exclusive promotion rights for Envafolimab in mainland China and completed treatment for over 20,000 patients within the first year of commercialization.

Cosela received conditional marketing approval in China in July 2022. It is the world’s first innovative drug with pan-myeloprotective effects administered prior to chemotherapy, developed through a collaboration between Simcere and G1 Therapeutics of the United States. By transiently arresting hematopoietic stem and progenitor cells in the bone marrow at the G1 phase of the cell cycle, it protects these cells from chemotherapy-induced damage. Clinical results demonstrated that, compared with placebo, Cosela significantly improved patients’ chemotherapy experience, reduced the incidence of fatigue, neutropenia, anemia, and thrombocytopenia, and decreased the use of G-CSF and the need for blood transfusions. The drug was launched in the United States in February 2021, and Simcere holds the rights for its commercialization in China.

Envida and Cosela are both newly launched drugs that are in the early stages of commercialization. Based on an analysis of their industry competitiveness, both products are expected to achieve rapid volume growth over the next two years.

As a long-established pharmaceutical enterprise in China, Simcere focuses on innovation and R&D-driven development in four major therapeutic areas: oncology, neuroscience, autoimmune diseases, and anti-infectives, with oncology being one of its core business segments.

Simcere, established in 1995, completed its secondary listing on the Hong Kong Stock Exchange in 2020 after delisting from the U.S. stock market. However, due to its label as a traditional generic drug manufacturer, its market capitalization has long been undervalued, with a price-to-earnings ratio consistently below 20x.

In recent years, Simcere has accelerated its transformation from a traditional pharmaceutical company to an innovative one. With multiple global innovative drugs launched consecutively, revenue from innovative drugs now accounts for over 70%, becoming the primary driver of performance growth. The “generic-to-innovative” strategy has entered a phase of tangible results.

Simcere has publicly stated that its innovative drug business will rapidly become the primary driver of the company’s sustained growth. In terms of R&D investment, Simcere has continuously increased its spending over the past five years, maintaining an R&D intensity of over 20% of revenue and accumulating total investments exceeding RMB 5 billion. Meanwhile, the proportion of revenue derived from innovative drugs has risen steadily, increasing from 33% in 2019 to 71% in the first half of 2023.

Meanwhile, Simcere places significant emphasis on business development (BD) investments and has become one of the fastest-growing pharmaceutical companies in China’s BD sector. On August 20, Simcere Zaiming, a subsidiary of Simcere, entered into a cooperation agreement with Mabwell Therapeutics regarding CMAB009, a domestically produced anti-EGFR monoclonal antibody. Under the terms of the agreement, Simcere Zaiming will obtain exclusive commercial rights to CMAB009 in mainland China.

CMAB009 is a recombinant anti-epidermal growth factor receptor (EGFR) chimeric monoclonal antibody, used in combination with FOLFIRI for the first-line treatment of metastatic colorectal cancer (mCRC). Clinical trial results have confirmed that CMAB009 demonstrates significantly superior efficacy compared to existing marketed traditional anti-EGFR monoclonal antibody drugs. Currently, the New Drug Application (NDA) for CMAB009 injection has been accepted by the China National Medical Products Administration, and it is poised to become the first domestically produced anti-EGFR monoclonal antibody approved for marketing in China for the treatment of mCRC.

Furthermore, in July 2023, daridorexant hydrochloride tablets, a novel anti-insomnia drug developed by Simcere in collaboration with the Swiss company Idorsia, were approved for clinical trials. In August 2023, LNK01001, a selective JAK1 inhibitor developed in partnership with LinkHealth Therapeutics, achieved positive top-line data from its Phase II clinical trial for the treatment of ankylosing spondylitis.

Through a differentiated pipeline layout and flexible business development (BD) strategies, Simcere is better positioned to capitalize on market windows of opportunity, thereby establishing a pipeline with leading R&D progress. This demonstrates that Simcere is no longer a traditional pharmaceutical company primarily focused on generic drugs, but has instead firmly established its identity as an innovation-driven enterprise.