China's Innovative Oncology Drug Sugemalimab Expands into Europe with $51.3M Upfront Deal

On May 27, CStone Pharmaceuticals (HKEX stock code: 2616), a company focused on the research and development of anti-tumor drugs, announced that it had entered into a strategic commercialization partnership with European pharmaceutical company Ewopharma, granting Ewopharma the commercialization rights for sugemalimab in Central and Eastern Europe.

Under the licensing and commercialization agreement, Ewopharma will obtain the commercialization rights for sugemalimab in Switzerland and 18 Central and Eastern European (CEE) countries. This includes the EU member states of Bulgaria, Croatia, the Czech Republic, Estonia, Hungary, Latvia, Lithuania, Poland, Romania, Slovakia, and Slovenia, as well as the non-EU countries of Albania, Bosnia and Herzegovina, Kosovo, North Macedonia, Moldova, Montenegro, and Serbia.

CStone Pharmaceuticals will receive an upfront payment of up to $51.3 million (approximately RMB 370 million), as well as subsequent regulatory and sales milestone payments. CStone Pharmaceuticals will generate international revenue by selling products to Ewopharma. Ewopharma will be responsible for pricing, reimbursement, marketing, distribution, and related matters, while CStone Pharmaceuticals will be responsible for product supply and providing necessary training and support for the relevant brands.

Dr. Yang Jianxin, CEO, President of R&D, and Executive Director of CStone Pharmaceuticals, stated that sugemalimab, an anti-PD-L1 monoclonal antibody, has demonstrated favorable efficacy in multiple clinical trials and has received approval for five indications in China. In the European market, the marketing authorization application for sugemalimab is expected to be approved by the European Medicines Agency (EMA) in the near future. Ewopharma is a specialized pharmaceutical marketing company with extensive experience and broad channels in the Central and Eastern European markets. This collaboration will undoubtedly help maximize the clinical and commercial value of sugemalimab in the European market, enabling more patients to benefit from this innovative drug. We look forward to working with Ewopharma to take a solid first step in the overseas commercialization of sugemalimab.

Alain Staub, CEO and Chairman of the Board of Ewopharma, stated, “We are delighted to enter into this strategic partnership with CStone Pharmaceuticals. Sugemalimab is an innovative therapy; its introduction will further expand our oncology portfolio and enable us to make a significant contribution to health equity in Switzerland and Central and Eastern Europe. According to GLOBOCAN 2022 data, lung cancer is the third most common cancer in Europe and a leading cause of cancer-related deaths, accounting for one-fifth of all cancer fatalities. Sugemalimab will improve the treatment landscape for patients with advanced non-small cell lung cancer.”

Sugemalimab, an anti-PD-L1 monoclonal antibody developed by CStone Pharmaceuticals, has received approval in China for all five indications that entered its registration clinical trials, including stage III and IV non-small cell lung cancer (NSCLC), extranodal NK/T-cell lymphoma, esophageal squamous cell carcinoma, and gastric cancer.

Furthermore, the European Medicines Agency (EMA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA) have both accepted the marketing authorization applications for sugemalimab in combination with chemotherapy as first-line treatment for metastatic NSCLC. Both applications are currently under review.

According to the company’s announcements, clinical data on sugemalimab have been presented multiple times at major international academic conferences and published in top-tier journals such as The Lancet Oncology, Nature Medicine, Nature Cancer, and the Journal of Clinical Oncology. The company is also engaging with regulatory authorities, including the European Medicines Agency (EMA), the Medicines and Healthcare products Regulatory Agency (MHRA), and the U.S. Food and Drug Administration (FDA), regarding marketing applications for indications of sugemalimab beyond non-small cell lung cancer (NSCLC), while actively expanding development and commercialization collaborations in other countries and regions worldwide.

CStone Pharmaceuticals focuses on the fields of tumor immunity and precision therapy, possessing a balanced portfolio of oncology assets, including 13 innovative products. To date, the company has obtained approvals for 12 new drug applications covering four innovative drugs. Among them, Pralsetinib^®, Taijihu^®, Zejiemei^®and TuoShuWo^®Taishiwei Receives Approval for New Drug Application from China's National Medical Products Administration^®AYVAKIT Approved for New Drug Application by Taiwan Food and Drug Administration^®with GAVRETO^®Obtained approval for new drug marketing application from the Department of Health, Hong Kong Special Administrative Region.

CStone Pharmaceuticals' R&D Pipeline

In addition, CStone Pharmaceuticals’ R&D Pipeline 2.0 includes four ADC product candidates: CS5001¹, CS5005, CS5006, and CS5007. Currently, CS5001¹ is in the early stages of clinical trials, while CS5005, CS5006, and CS5007 are in the preclinical stage.

CS5001¹ is an antibody-drug conjugate (ADC) targeting receptor tyrosine kinase-like orphan receptor 1 (ROR1). It features a unique design incorporating a tumor-specifically activated pyrrolobenzodiazepine (PBD) prodrug payload and linker. CS5001¹ remains inert until it reaches the tumor site, where it is internalized by tumor cells. Within the lysosomes, the linker is cleaved by specific enzymes highly expressed in tumor cells, releasing the PBD prodrug. The PBD prodrug is then activated intracellularly, leading to tumor cell death. This "dual-control" mechanism of the linker plus prodrug effectively mitigates toxicity issues associated with traditional PBD payloads, thereby achieving a wider safety window. CS5001¹ has demonstrated complete tumor inhibition in several preclinical cancer models and exhibited favorable serum half-life and pharmacokinetic profiles. These attributes are expected to translate into broad therapeutic indications across various solid and hematologic malignancies. Furthermore, CS5001¹ utilizes site-specific conjugation technology to achieve a precise drug-to-antibody ratio (DAR), facilitating homogeneous and large-scale manufacturing.

Over the past two years, interest in ADC assets has surged significantly. With its differentiated design, CStone Pharmaceuticals’ CS5001¹ demonstrates “best-in-class” potential and may emerge as the next major contender for blockbuster business development (BD) deals.

At the end of last year, CStone Pharmaceuticals entered into multiple commercialization collaborations with several companies to further enhance its commercial efficiency.

In November 2023, CStone Pharmaceuticals and 3SBio entered into a strategic collaboration in mainland China regarding nofazinlimab, granting 3SBio exclusive rights to develop, register, manufacture, and commercialize nofazinlimab in mainland China.

In November 2023, CStone Pharmaceuticals and Allist entered into a commercial partnership in China for the promotion and commercialization of pralsetinib. This transaction integrates pralsetinib into Allist’s highly synergistic lung cancer business unit, enabling the drug to benefit from Allist’s more mature commercial team and broader market coverage. Meanwhile, it allows CStone Pharmaceuticals to reduce operating expenses and costs associated with the commercialization of pralsetinib, thereby enhancing overall profitability.

In December 2023, CStone Pharmaceuticals transferred the rights to ivosidenib in Greater China and Singapore to Servier, the global license holder, for a total consideration of up to $50 million (including an upfront payment of $44 million for the transfer of the ivosidenib business). This high-value transaction enabled CStone Pharmaceuticals to recoup its initial investment in the asset and monetize the future potential cash flows from the business.

Adopting a business development (BD) strategy, CStone Pharmaceuticals has entered into three consecutive out-licensing partnerships, significantly transferring the commercialization rights of its flagship products. This move reflects the company’s strategic adjustment in commercialization amid the industry downturn. Furthermore, CStone Pharmaceuticals is further streamlining its sales team.

This strategy, in fact, reflects the commercialization challenges that most innovative drug companies in China are likely to face in the near future.

Ultimately, the core competitiveness of innovative drug companies lies in pipeline innovation, rather than in building a comprehensive commercialization system. Therefore, it is a highly pragmatic approach for these enterprises to partner with companies possessing stronger commercialization capabilities after completing phased research or achieving key milestones. Only a very small number of innovative drug companies have the opportunity to establish their own fully integrated commercialization pathways, which is a critical challenge that Chinese pharmaceutical companies must confront.

CStone Pharmaceuticals has stated that the purpose of accelerating strategic cooperation is to leverage the respective strengths of both parties. In the future, the company will focus its strategic efforts on research and development (R&D), promoting the R&D and market launch of more differentiated innovative drugs. Meanwhile, the company currently has multiple products approaching or reaching the Investigational New Drug (IND) stage, and it will continue to advance the R&D and commercialization of additional innovative therapies.

References:

CStone Pharmaceuticals Divests Three Major Assets Within Two Months in Major “Slim-Down” – Being Science