CStone Pharmaceuticals and Pfizer Announce Strategic Collaboration to Address Oncology Needs in China

Suzhou, September 30, 2020 /PRNewswire/ -- CStone Pharmaceuticals (HKEX stock code: 2616) and Pfizer Inc. (NYSE stock code: PFE)’s subsidiaries, Pfizer Investment Co., Ltd. (“Pfizer Investment”) and Pfizer Hong Kong Limited (“Pfizer Hong Kong”), today announced the establishment of a strategic partnership. This includes a USD 200 million equity investment by Pfizer Hong Kong in CStone Pharmaceuticals, collaboration between CStone Pharmaceuticals and Pfizer Investment on the development and commercialization of sugemalimab (CS1001, a PD-L1 antibody) in mainland China, as well as a framework for cooperation between CStone Pharmaceuticals and Pfizer Investment to introduce additional oncology products into the Greater China region.

Sugemalimab, a PD-L1 antibody developed by CStone Pharmaceuticals with the potential to become best-in-class, has potential indications covering multiple cancer types with high incidence in China, including lung cancer, gastric cancer, and esophageal cancer. This collaboration provides financial support for CStone Pharmaceuticals to further develop sugemalimab. Meanwhile, Pfizer has obtained exclusive rights from CStone Pharmaceuticals to commercialize sugemalimab in China, leveraging its industry-leading commercialization capabilities to accelerate access to this innovative therapy for doctors and patients across broader regions of China. The partnership will also enable CStone Pharmaceuticals and Pfizer to jointly develop and commercialize additional innovative oncology products in the Greater China region.

“Pfizer’s investment in CStone Pharmaceuticals not only demonstrates its strong confidence in the potential of our oncology PD-L1 therapy, but also serves as an endorsement of our R&D capabilities,” said Dr. Jiang Ningjun, Chairman and CEO of CStone Pharmaceuticals. “By partnering with Pfizer and leveraging its commercialization capabilities, we will ensure that patients across broader regions of China can benefit more rapidly from our highly differentiated PD-L1 therapy. Furthermore, building on this collaboration, CStone Pharmaceuticals will accelerate the development and commercialization of globally innovative therapies for Chinese patients, further transforming into a fully integrated biopharmaceutical company.”

“Pfizer has long been committed to ‘delivering breakthroughs that change patients’ lives,’ a mission we have always taken pride in,” said Pierre Gaudreault, Acting President of Pfizer’s Biopharmaceutical Group in China. “Our collaboration with CStone Pharmaceuticals adds another significant chapter to this journey, as we support the development of this potential best-in-class PD-L1 inhibitor and its subsequent commercialization upon approval. By partnering with companies possessing outstanding clinical development capabilities, we aim to help address the unmet oncology treatment needs of patients in China.”

Key Cooperation Terms and Financial Provisions 

The transaction has obtained the necessary internal approvals from both companies. Closing does not require approval from CStone Pharmaceuticals’ shareholders.

Goldman Sachs & Co. LLC served as the financial advisor to CStone Pharmaceuticals, and Cooley LLP served as the legal counsel to CStone Pharmaceuticals. Clifford Chance LLP served as the legal counsel to Pfizer.

Investor Meeting Information

CStone Pharmaceuticals will host a web conference at 11:00 a.m. (Hong Kong time) on September 30, 2020. Please refer to the following information for participation.

Outside Mainland China:https://event.webcasts.com/starthere.jsp?ei=1380037&tp_key=735ccdf3e4

Mainland China:https://event.gmwebcasts.cn/starthere.jsp?ei=1380037&tp_key=735ccdf3e4

Meeting Password (Case-Sensitive): CStone

About Sugemalimab

Sugemalimab is an investigational anti-PD-L1 monoclonal antibody under development by CStone Pharmaceuticals. The development of sugemalimab is based on the OmniRat technology licensed from Ligand Pharmaceuticals, Inc. in the United States.^®Transgenic Animal Platform. This platform enables the one-stop generation of fully human antibodies. As a fully human, full-length anti-PD-L1 monoclonal antibody, sugemalimab is a monoclonal antibody drug that most closely resembles natural human immunoglobulin G4 (IgG4). Sugemalimab carries a lower risk of immunogenicity and related toxicity in patients, thereby demonstrating potential unique advantages compared to similar drugs.

Sugemalimab has completed dose escalation in Phase I clinical studies in China. In the Phase Ia and Ib studies, sugemalimab demonstrated activity across multipleIndicationsdemonstrated favorable antitumor activity and tolerability in both.

Currently, sugemalimab is undergoing multiple clinical studies. In addition to a U.S. bridging Phase I study, in China, sugemalimab is being evaluated in a multi-arm Phase Ib clinical study across multiple cancer types, a Phase II registrational clinical study for lymphoma, and four Phase III registrational clinical studies for third- and fourth-line non-small cell lung cancer, gastric cancer, and esophageal cancer, respectively.

About CStone Pharmaceuticals

CStone Pharmaceuticals is a biopharmaceutical company dedicated to the development and commercialization of innovative immuno-oncology and precision medicine therapies, addressing the urgent medical needs of cancer patients in China and worldwide. Established in late 2015, CStone Pharmaceuticals has assembled a world-class management team with extensive experience in new drug research and development, clinical studies, and commercialization. Centered on combination immuno-oncology therapies, the company has built a robust pipeline of 15 oncology drug candidates, five of which are in pivotal clinical trials or registration stages. Leveraging its experienced management team, rich pipeline, business model focused on clinical development, and ample capital, CStone Pharmaceuticals aims to become a globally recognized, leading Chinese biopharmaceutical company by delivering innovative oncology treatments to cancer patients worldwide. For more information about CStone Pharmaceuticals, please visit:www.cstonepharma.com。

About Pfizer:Delivering Life-Changing Breakthrough Innovations to Patients

At Pfizer, we are committed to applying science and our global resources to deliver treatments that extend and significantly improve human life. We have established standards for quality, safety, and value throughout the exploration, research, development, and manufacturing of our healthcare products, including innovative medicines and vaccines. Every day, Pfizer colleagues in both developed and emerging markets work to advance health and develop preventive and therapeutic solutions capable of addressing the most challenging diseases of our time. Pfizer also collaborates with healthcare professionals, governments, and communities around the world to support greater access to reliable and affordable healthcare services. This aligns with Pfizer’s responsibility as a leading innovative biopharmaceutical company. For more than 170 years, Pfizer has worked to provide better, higher-quality services to people. For more information, please visitwww.pfizer.com。

Forward-Looking Statements

The forward-looking statements made in this document relate only to events or information as of the date on which such statements are made. Except as required by law, we have no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or other reasons arising after the date such statements are made, or to reflect the occurrence of unanticipated events. Please read this document in its entirety and understand that our actual future results or performance may differ materially from expectations. Statements or references regarding our intentions, the intentions of any of our directors, or the intentions of the Company are made as of the date of this document and are subject to change due to future developments.