Sanofi and Alphamab Oncology Announce Strategic Clinical Collaboration to Advance KN026 in HER2-Positive Breast Cancer

Shanghai, June 9, 2020 /PRNewswire/ -- Sanofi and Alphamab Oncology today announced that the two companies have signed an agreement to establish a strategic collaboration: both parties will jointly advance KN026 and Taxotere for patients with HER2-positive breast cancer^®(Docetaxel) combination therapy clinical trials. According to the terms of the agreement, upon reaching specific clinical milestones, Sanofi will have the right to negotiate for the exclusive license to introduce KN026 during the exclusivity period.

KN026 is an anti-HER2 bispecific antibody that simultaneously binds to two non-overlapping epitopes of HER2, resulting in dual HER2 signaling blockade and purportedly inducing HER2 clustering on the cell surface followed by internalization. Preliminary clinical trials have demonstrated that KN026 exhibits promising efficacy and an excellent safety profile in patients with advanced breast cancer who have progressed after multiple prior therapies, laying a solid foundation for the subsequent development of combination regimens in earlier lines of treatment. Based on its clinical profile, KN026 has the potential to meet the treatment needs of approximately two million HER2-positive breast cancer patients across the major markets in China, the United States, and Europe.

Taxotere^®(Docetaxel Injection) is a microtubule inhibitor that inhibits the growth and spread of cancer cells in the body. Taxotere^®Commonly used for the treatment of breast cancer, lung cancer, prostate cancer, and gastric cancer. In China, Taxotere^®Indications approved in the field of breast cancer include: 1) treatment of locally advanced or metastatic breast cancer; 2) docetaxel in combination with trastuzumab for the treatment of patients with HER2-overexpressing metastatic breast cancer who have not previously received chemotherapy for metastatic disease; 3) docetaxel in combination with doxorubicin and cyclophosphamide for postoperative adjuvant chemotherapy in patients with node-positive breast cancer.

“Based on Sanofi's strength in the oncology field, we see aExcellentOpportunity, namely through collaboration with Alphamab Oncology, a leading biopharmaceutical company in China,YesBreast Cancer Patientshas a positive impact on health。"Dr. Pius S. Hornstein, General Manager of Sanofi’s Global Generics Business Unit in China and President of Sanofi China, stated,"This strategic partnership also demonstrates Sanofi’s desire to play a more active role in China’s healthcare ecosystem, by collaborating with other leading companies to provide more for the broad Chinese populationWoundNew Therapy.”

 “KN026 It is the core product of Alphamab Oncology's innovative bispecific antibody pipeline, inCurrentDemonstrated very significant in clinical studiesEfficacy and SafetyAdvantages."Dr. Xu Ting, Founder, Chairman, and President of Alphamab Oncology, stated,"HER2 The unmet treatment needs of patients with hormone receptor-positive breast cancer remain substantial, and we aim to accelerate implementation through our collaboration with Sanofi, a global leader in biopharmaceuticals. KN026 's global development strategy, forHER2 Provide Superior Treatment Regimens for Patients with Positive Breast Cancer.”

Under the terms of the agreement, Sanofi will collaborate with Alphamab Oncology to evaluate the efficacy of the dual-drug combination in HER2-positive breast cancer. The initial multicenter, open-label study has officially begun enrolling patients.

About Alphamab Oncology

Alphamab Oncology is a biopharmaceutical company focused on the research and development, manufacturing, and commercialization of innovative large-molecule biologics for cancer treatment. On December 12, 2019, the company was listed on the Main Board of The Stock Exchange of Hong Kong Limited, with stock code: 9966.

Alphamab Oncology possesses a fully integrated research, development, and manufacturing platform for bispecific antibodies and protein engineering. The company’s highly differentiated pipeline comprises eight oncology drug candidates, including six globally leading bispecific antibodies, with four products currently in Phase I–III clinical trials in China, the United States, and Japan.

The company possesses multiple proprietary technology platforms, including those for bispecific heterodimers and mixed antibodies, along with mature large-scale manufacturing capabilities compliant with Chinese, US, and EU cGMP standards. Leveraging these internationally leading protein engineering platforms, the company is developing a new generation of multifunctional biologic drugs to benefit patients in China and worldwide.

Welcome to the company website:www.alphamabonc.com

About Sanofi China

Sanofi is a global leader in biopharmaceuticals, dedicated to human health. As one of the first multinational corporations to enter China after the launch of the reform and opening-up policy, Sanofi established its office in China in 1982. Sanofi China’s diversified portfolio spans pharmaceuticals, human vaccines, and consumer healthcare. In China, Sanofi operates 12 offices, three manufacturing sites, four major R&D centers, and one digital innovation hub. Sanofi is committed to accelerating the introduction of innovative medicines and vaccines into China and leading digital innovation to meet the health needs of the broadest possible population in China.

For more information, please visitwww.sanofi.cn, or follow the “Sanofi China” WeChat Official Account and the “Sanofi” LinkedIn account.

About Sanofi

Sanofi is dedicated to helping people navigate health challenges. As a global biopharmaceutical company focused on human health, we prevent diseases through vaccines and provide innovative therapies to alleviate pain and suffering. We support the small number of individuals affected by rare diseases, as well as the millions of patients living with chronic conditions.

Sanofi has more than 100,000 employees across over 100 countries, dedicated to transforming scientific innovation into healthcare solutions.

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