BeiGene and Novartis Strengthen Strategic Collaboration to Accelerate Global Expansion of Tislelizumab, a High-Quality PD-1 Inhibitor Developed in China

[Beijing, China, January 21, 2021] The strategic collaboration celebration between BeOne Medicines and Novartis was grandly held in Beijing. The two parties will collaborate on the development and commercialization of BeOne Medicines’ self-developed anti-PD-1 antibody drug, Baizean® (generic name: tislelizumab injection), in multiple overseas countries. This collaboration marks another industry milestone for BeOne Medicines, following the FDA approval of zanubrutinib in 2019, which achieved the “zero breakthrough” for Chinese domestically developed innovative anticancer drugs entering international markets.

Mr. John V. Oyler, Co-founder, Chairman, and Chief Executive Officer of BeOne Medicines, and Dr. Vas Narasimhan, Global Chief Executive Officer of Novartis, joined the celebration remotely from the United States and Switzerland, respectively. Dr. Wu Xiaobin, General Manager of BeOne Medicines China and President of the Company; Mr. Dan Brindle, President of Novartis China; Mr. Alexandre Gibim, General Manager of Novartis Oncology China; and Professor Wang Jie, Director of the Department of Medical Oncology at the Cancer Hospital of the Chinese Academy of Medical Sciences, were among the dignitaries who jointly witnessed this significant historic moment.

Mr. John Oyler, Co-founder, Chairman and CEO of BeOne Medicines (left), and Dr. Vas Narasimhan, Global CEO of Novartis (right), participated in the celebration via remote video link.

In his address, Mr. John V. Oyler, Co-founder, Chairman, and Chief Executive Officer of BeOne Medicines, stated, “Providing effective, accessible, and affordable high-quality medicines to cancer patients worldwide is the vision and mission of BeOne Medicines. This collaboration between Novartis and BeOne Medicines not only demonstrates their recognition of the differentiated potential of BAIZELAN®, a PD-1 monoclonal antibody, but also conveys the shared mission and commitment of both parties to bring more innovative treatment options to patients around the world as early as possible.”

Dr. Vas Narasimhan, Global CEO of Novartis, stated: “Novartis continuously reimagines the future of medicine and actively collaborates with companies possessing high-level innovation capabilities to jointly advance biopharmaceutical innovation. We look forward to partnering with BeOne Medicines to continue the development of BAIZETAN® and to expand global access to BAIZETAN® and its related combination therapies. With the efforts and progress made by the Chinese government in fostering an innovative environment, we anticipate the emergence of more biotechnology companies in China with world-class innovation capabilities.”

BeOne Medicines and Novartis signed this strategic cooperation agreement earlier this month. Completion of the transaction is subject to the satisfaction of closing conditions, including the expiration or early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act.

Structural Optimization and Differentiated Advantages Create a Model for Global Expansion

Baizean® is a Class 1 novel drug independently developed by BeOne Medicines, designed to minimize its binding to Fcγ receptors on macrophages. In December 2019, Baizean® received conditional approval from the National Medical Products Administration (NMPA) for the treatment of patients with relapsed or refractory classical Hodgkin lymphoma (R/R cHL). In April 2020, Baizean® was conditionally approved for the treatment of patients with locally advanced or metastatic urothelial carcinoma (UC), becoming the only immuno-oncology drug approved in China for this indication. In January 2021, Baizean® secured another new indication, with its marketing application for use in combination with chemotherapy as first-line treatment for advanced squamous non-small cell lung cancer (hereinafter referred to as "squamous lung cancer") officially approved, making it the first domestically produced PD-1 monoclonal antibody to obtain an indication for squamous lung cancer.

Professor Wang Jie, Chief Physician at the Cancer Hospital of the Chinese Academy of Medical Sciences and Leading Principal Investigator (Leading PI) for the squamous non-small cell lung cancer indication of Baizean®, stated in her remarks: “Baizean® has not only just received approval for the squamous non-small cell lung cancer indication, but its marketing application for another new indication—combination with chemotherapy for the first-line treatment of advanced non-squamous non-small cell lung cancer—has also been accepted. It is a proud achievement that Baizean® has sequentially yielded positive results in two major first-line clinical trials for squamous and non-squamous non-small cell lung cancer, which reflects BeOne Medicines’ advanced R&D capabilities and philosophy. We look forward to the strong partnership between BeOne Medicines and Novartis to bring this novel anticancer drug with proven clinical benefits to the global market as soon as possible.”

# With a Visionary Outlook, Accelerating Global Expansion to Benefit More Patients

BeOne Medicines initiated the development of BAIZEAN® in 2012, and after more than seven years, successfully brought this high-quality global PD-1 monoclonal antibody to market. In December 2020, BAIZEAN® was included in the updated National Reimbursement Drug List. As the first domestically produced PD-1 monoclonal antibody to conduct clinical trials overseas and currently holding the largest number of global clinical trials among its peers, BAIZEAN® has launched 15 registrational clinical trials worldwide. These trials cover cancer types such as lung cancer, liver cancer, esophageal squamous cell carcinoma, gastric cancer, and nasopharyngeal carcinoma, enrolling over 7,700 patients globally, including approximately 2,500 patients from 20 countries and regions outside mainland China.

Dr. Wu Xiaobin, General Manager of BeOne Medicines’ China region and President of the company, stated: “Novartis is a recognized leader in the field of oncology, possessing a unique and robust portfolio of anti-tumor products and R&D pipeline. We are proud to witness the establishment of the collaboration between BeOne Medicines and Novartis, which will further expand the potential of Baizean® and Novartis products in multiple combination therapies and indication expansions, bringing more innovative treatment options to patients worldwide. BeOne Medicines looks forward to working with industry peers not only to develop the best anticancer drugs for the Chinese people but also, as a Chinese company, to deliver the best anticancer drugs to the world!”

Address by Dr. Wu Xiaobin, General Manager of BeOne Medicines China and President of the Company

Mr. Bedonian, President of Novartis China, stated, “Novartis is committed to providing innovative medicines for patients in China, raising the standards of diagnosis and treatment, while actively contributing to the sustainable development of society as a whole—this reflects our long-term commitment to China. We will continue to collaborate actively with enterprises and academic associations in China’s pharmaceutical and healthcare sectors to jointly drive innovation, with the aim of improving and extending people’s lives. Our collaboration with BeOne Medicines further demonstrates Novartis’ ongoing efforts to explore new ways to serve patients and advance industry development.”

Address by Mr. Daniel Bedoni, President of Novartis (China)

From the U.S. FDA approval of zanubrutinib, a BTK inhibitor independently developed by BeOne Medicines, which marked the first breakthrough for Chinese domestically developed anti-cancer new drugs in going global, to the collaboration with Novartis to advance the international launch of Baizean®, the development journey of BeOne Medicines is not only a microcosm of the rise and growth of local innovative pharmaceutical companies in China in recent years, but also reflects the global pharmaceutical industry’s strong recognition of BeOne Medicines’ commitment to an independent R&D-driven global development path and its robust research and development capabilities. As the globalization process of local innovative pharmaceutical enterprises accelerates, more Chinese innovative drug companies are expected to deliver higher-quality innovative medicines to patients within the global new drug creation system.