Total revenue of RMB 254.2 million for 2024 H1; achieving first-time profitability with cash reserve at RMB 814 million as of June 30, 2024.
NDA approval of sugemalimab (PD-L1) for Stage IV NSCLC in EU, marking the first successful international approval of a China domestic anti-PD-L1 mAb.
Partnered with Ewopharma for sugemalimab commercialization in Central and Eastern Europe, expecting more global partnerships for sugemalimab in the rest of 2024. To launch sugemalimab in Europe and other ex-China markets in early 2025 and to support the company to achieve sustained profitability.
Key Pipeline 2.0 asset – CS5001, the first ROR1 ADC with clinical anti-tumor activity in both solid tumors and lymphomas; initiation of a phase 1b study in lymphomas with registrational potential expected in 2024.
Key Pipeline 2.0 asset – CS2009, a trispecific antibody targeting PD-1, CTLA4, and VEGFa; aiming for IND submissions in 2024 / 2025.
Partnered with Hengrui Pharmaceuticals to commercialize AYVAKIT® (avapritinib) in mainland China.
AYVAKIT®'s manufacturing localization application approved by China NMPA; GAVRETO®'s (pralsetinib) application under review. Domestic manufacturing of both precision medicines will significantly reduce costs and improve long-term profitability.
New NDA approval of sugemalimab (PD-L1) for first-line gastric cancer in China; NDA for Stage IV NSCLC currently under review by UK MHRA.
The Company to host an interim results investor conference call in Chinese on August 26th at 10:00-11:00 am HKT.
SUZHOU, China, Aug. 23, 2024 /PRNewswire/ -- CStone Pharmaceuticals (HKEX: 2616), an innovation-driven biopharmaceutical company focused on the research and development of anti-cancer therapies, today reported interim financial results for 2024 and recent business highlights.
Dr. Jason Yang, CEO, President of R&D, and Executive Director of Board at CStone, said, "The first half of 2024 marks an important turning point for CStone's growth, achieving several critical milestones and outstanding financial performance. With diversified revenue streams and ongoing cost control, we achieved profitability for the first time and laid a solid foundation for company's future growth.
The EU approval of sugemalimab for first-line Stage IV NSCLC represents a significant breakthrough in our global strategy. In addition to the commercial agreement reached this year with Ewopharma for Central and Eastern Europe, we anticipate expanding sugemalimab partnerships across Western Europe and other regions in the rest of 2024, with global sales to commence from early 2025. We are confident that sugemalimab – a potential best-in-class anti-PD-L1 antibody – will deliver significant revenue to support the company to achieve sustained profitability.
Pipeline 2.0 is the "new growth engine" for CStone. We will initiate a phase 1b study of CS5001 (ROR1 ADC) with registrational potential for lymphoma in 2024, and plan to present updated clinical data at the American Society of Hematology (ASH) annual meeting later this year. CS2009 (a trispecific antibody targeting PD-1, CTLA4, and VEGFa) is expected to enter an FIH clinical trial in 2024/2025. Meanwhile, we are advancing more innovative assets for oncology and autoimmune diseases with global rights towards clinical stage.
Following the commercialization agreement with and successful transition to Allist to commercialize GAVRETO® (pralsetinib) in China last year, we entered a partnership with Hengrui Pharmaceuticals to commercialize AYVAKIT® (avapritinib) in China to leverage its large and strong sale force. Earlier this year, we received the approval for AYVAKIT®'s manufacturing localization application and filed an application for GAVRETO®. With reduced costs of goods from local supply and the strong commercial capability from our partners, we expect rapid sales growth for these two precision medicines to contribute sustainable profit to the Company in coming years.
In terms of regulatory progress, sugemalimab received approval in mainland China for first-line gastric cancer, further broadening its coverage in the domestic market. In ex-China market, the UK Medicines and Healthcare products Regulatory Agency (MHRA) is currently reviewing sugemalimab marketing authorization application (MAA) for first-line Stage IV NSCLC that has recently been approved by the European Commission (EC). We plan to submit additional MAAs to the European Medicines Agency (EMA) for other indications of sugemalimab, including Stage III NSCLC, first-line gastric cancer, first-line esophageal squamous cell carcinoma (ESCC), and relapsed/refractory extranodal NK/T-cell lymphoma.
Looking ahead, CStone will work closely with our commercial partners to drive the commercial performance of AYVAKIT® and GAVRETO® in China and sugemalimab globally, continue to advance the innovative assets in Pipeline 2.0 to the clinic, and expand our global business to achieve sustained profitability."
Financial Highlights
International Financial Reporting Standards (IFRS) Measures:
Revenue was RMB254.2 million for the six months ended June 30, 2024, composed of RMB118.3 million in sales of pharmaceutical products (avapritinib and pralsetinib), RMB122.6 million in license fee income and RMB13.3 million in royalty income of sugemalimab, representing an increase of RMB122.6 million in license fee income which largely offset a decrease of RMB128.6 million in revenue from sales of pharmaceutical products, such that total revenue decreased by RMB7.3 million, ...
