BeiGene Expands Strategic Collaboration with Novartis to Co-Develop and Commercialize Ociperlimab and Introduce Five Novartis Oncology Products in China

Beijing, China、Basel, Switzerland and Cambridge, Massachusetts, USA, December 20, 2021 /PRNewswire/ -- BeOne Medicines (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company focused on the development and commercialization of innovative medicines worldwide, announced today that it has entered into an option, collaboration, and license agreement with Novartis AG. Under the agreement, the two parties will co-develop, manufacture, and commercialize BeOne Medicines' investigational TIGIT inhibitor, Ociperlimab, in North America, Europe, and Japan. Additionally, the parties have agreed to grant BeOne Medicines the rights to market, promote, and sell Tafinlar in designated regions within China (referred to as the "vast market").^®(Dabrafenib), Mekinist^®(Trametinib), Votrient^®(Pazopanib), Afinitor^®(Everolimus) and Zaneka^®(Ceritinib) -- Rights to five approved Novartis oncology drugs.

BeOne Medicines and Novartis announced in January 2021 on the anti-PD-1 antibody drug Beigene^®(Tislelizumab) for collaboration. Furthermore, BeOne Medicines grants Novartis an exclusive, time-based option to co-develop Ociperlimab, which Novartis can exercise before the end of 2023. After the option takes effect, Novartis will be responsible for regulatory submissions post-transition period and commercialization within the licensed region upon receiving regulatory approval. During the option period, Novartis will fund and advance new global clinical trials to explore the combination of Ociperlimab with Tislelizumab in specific tumor types. Additionally, after exercising the option, both companies may conduct global clinical trials to explore the combination of Ociperlimab with other anti-cancer drugs. Following marketing approval, BeOne Medicines will co-commercialize Ociperlimab in the United States.

Ociperlimab is a potent investigational TIGIT inhibitor with full Fc functionality. The Fc region is crucial for the anti-tumor activity of TIGIT antibodies. Two global Phase 3 clinical trials, AdvanTIG-301 and AdvantTIG-302, are exploring Ociperlimab, this immune checkpoint inhibitor, in combination with BeOne Medicines.^®Combined for the treatment of non-small cell lung cancer (NSCLC). To date, approximately 600 subjects worldwide have been enrolled in the Ociperlimab development program, including six global trials targeting lung cancer, esophageal squamous cell carcinoma, and cervical cancer.

BeOne Medicines Co-Founder, CEO and Chairman John Oyler said, "We are very pleased that Novartis has joined the development of Ociperlimab - one of the most advanced anti-TIGIT antibodies currently available. Regarding our collaboration with Novartis on BeiGene's^®"On the basis of achieving successful cooperation, we are highly looking forward to exploring more synergies in both pipelines and accelerating the market launch of Ociperlimab. Our commercialization team in China has already reached a considerable scale, with over 3,100 members who possess strong scientific backgrounds. The team is fully prepared to bring the five anti-cancer drugs recently licensed from Novartis to a broad base of Chinese patients urgently in need of such treatments. This is a multi-dimensional and highly significant collaboration, made possible by the foundation of cooperation jointly built by both parties and their shared commitment to patients worldwide."

OciperlimabOption, Cooperation and Authorization Agreement

Under the terms of the Ociperlimab agreement, BeOne Medicines will receive a $300 million cash upfront payment from Novartis and is eligible to receive an additional $600 or $700 million payment if Novartis exercises its exclusive, time-based option between mid-2023 or mid-year to the end of 2023, subject to obtaining required antitrust approvals. Additionally, upon Novartis' exercise of the option, BeOne Medicines is entitled to receive up to $745 million in regulatory milestone payments, $1.15 billion in sales milestone payments, and royalties based on Ociperlimab sales in the licensed territory. The licensed territory is consistent with the previous authorization for BeOne Medicines.^®in collaboration with countries including the United States, Canada, Mexico, EU member states, the United Kingdom, Norway, Switzerland, Iceland, Liechtenstein, Russia, and Japan. Under the terms of the agreement, Novartis has agreed to fund and initiate new global clinical trials of Ociperlimab during the option period, while BeOne Medicines has agreed to expand recruitment for two ongoing clinical trials. Additionally, Novartis has agreed to share the development costs of global trials after exercising the option. Following marketing approval, BeOne Medicines will be responsible for 50% of co-commercialization activities and co-medical affairs in the U.S. market and will have the option for up to 25% co-commercialization rights in the Canadian and Mexican markets, partially funded by Novartis. Both parties retain the right to commercially develop combination therapies involving Ociperlimab with their proprietary products globally, such as BeiGene’s existing agreement on Tislelizumab.^®。

Commercial Development of Novartis Products in the Chinese Market

According to the terms of the commercial development agreement, BeOne Medicines has the right to market and promote five Novartis drugs that have been approved and included in the National Reimbursement Drug List within designated areas in China (namely the "vast market"). The products include:

China’s vast market includes approximately 13,000 hospitals in cities, districts, and counties, covering around 500,000 cancer patients. BeOne Medicines’ self-developed and licensed products already hold a significant market share in these regions.

About  Ociperlimab

Ociperlimab is an investigational humanized IgG1 monoclonal antibody independently developed by BeOne Medicines and being developed globally. As an immune checkpoint candidate drug, Ociperlimab is one of the most advanced anti-TIGIT antibodies currently in development, with complete Fc functionality. Inhibition of the TIGIT target provides a potential mechanism to rescue immune cells (such as T cells, NK cells, and dendritic cells) from an immunosuppressive tumor microenvironment to induce effective anti-tumor immune responses. The TIGIT pathway is believed to collaborate with PD-1 to maximally suppress effector tumor-infiltrating immune cells and enhance resistance to anti-PD-1 therapies. TIGIT is considered a promising target that could potentially increase the benefits of anti-PD-1 therapies for more patients.

Currently, Ociperlimab in combination with BeOne Medicines' anti-PD-1 antibody drug, Tislelizumab^®Multiple clinical trials are currently underway, including:

BeOne Medicines and Novartis Collaboration 

In January 2021, BeOne Medicines and Novartis announced a collaboration granting Novartis the rights to develop, manufacture, and commercialize BeOne Medicines' anti-PD-1 antibody drug, Tislelizumab, in North America, Europe, and Japan.^®(Tislelizumab) rights. Since the cooperation agreement became effective in February 2021, the two companies have achieved key objectives of the collaboration, including the submission of the first New Drug Application (BLA) for tislelizumab outside of China, specifically for the treatment of patients with unresectable, recurrent locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) who have previously undergone systemic therapy. The U.S. Food and Drug Administration (FDA) has accepted this BLA. Under the Prescription Drug User Fee Act (PDUFA), the FDA’s target action date is July 12, 2022. Additionally, the two companies are closely collaborating on pre-launch activities and are on track to prepare additional BLAs for tislelizumab, as well as exploring combination therapies involving tislelizumab with products and pipelines from each company's portfolio. Based on the current progress of their collaboration and a shared commitment to bring new therapies to more patients, the two parties have reached a new agreement to jointly develop, manufacture, and commercialize BeOne Medicines' TIGIT inhibitor, Ociperlimab.

About BeOne Medicines Oncology

BeOne Medicines, through independent research and development or in collaboration with like-minded partners, continuously advances the development of best-in-class or first-in-class clinical drug candidates. The company is committed to providing impactful, accessible, and affordable medicines for patients worldwide. BeOne Medicines' global clinical research and development team comprises approximately 2,750 members, with the team size continuing to expand. This team is currently supporting over 90 ongoing or planned clinical studies globally (more than 70 clinical studies are currently underway), having recruited over 14,000 patients and healthy volunteers. BeOne Medicines' internal clinical development team plans and leads the research and expansion of the company’s product pipeline, providing support and guidance for clinical trials covering more than 45 countries/regions worldwide. The company places special emphasis on targeted therapies and immuno-oncology treatments for hematologic malignancies and solid tumors, with a focus on researching monotherapies and combination therapies. Currently, three self-developed drugs from BeOne Medicines have been approved for marketing: Brukinsa.^®(BTK inhibitor, approved for marketing in the United States, China, the European Union, Canada, Australia, and other international markets), BeOne Medicines^®(An anti-PD-1 antibody that effectively avoids Fcγ receptor binding, already approved and marketed in China) and BeiGene's BGB-A317^®(PARP inhibitor, already approved for marketing in China).

At the same time, BeOne Medicines collaborates with other innovative companies to jointly advance the research and development of novel therapies in order to meet global health needs. In China, BeOne Medicines is marketing several oncology drugs licensed from Amgen, Bristol-Myers Squibb, EUSA Pharma, and Bio-Thera. The company also addresses unmet medical needs worldwide to a greater extent through partnerships with several companies, including Amgen, Mirati Therapeutics, Seagen, and Zymeworks.

About BeOne Medicines

BeOne Medicines is a global biotechnology company grounded in science, focused on developing innovative and affordable medicines to improve treatment outcomes and enhance drug accessibility for patients worldwide. The company’s extensive portfolio currently includes over 40 clinical candidates. By strengthening its independent R&D capabilities and fostering collaborations, BeOne Medicines accelerates the development of a diverse and innovative pipeline of drugs. We are committed to comprehensively improving drug accessibility for more than 2 billion people globally by 2030. BeOne Medicines has built a team of over 8,000 employees across five continents. For more information, please visit our official website.www.beigene.com.cn。 

Forward-Looking Statements

This press release contains forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding Ociperlimab and BeOne Medicines.^®Project advancement, anticipated clinical development and regulatory milestones, as well as commercialization; the expected expansion and acceleration of Ociperlimab's clinical development; Novartis' exercise of its option, potential payments BeOne Medicines could receive as a result, and obtaining the required antitrust approvals; commitments from both parties and the potential benefits that may arise from the Ociperlimab collaboration and broader market agreement, as well as BeOne Medicines’ plans, commitments, aspirations, and goals mentioned under the subtitles "About BeOne Medicines Oncology" and "About BeOne Medicines." Due to various significant factors, actual results may materially differ from forward-looking statements. These factors include: BeOne Medicines’ ability to demonstrate the efficacy and safety of its drug candidates; clinical outcomes of the drug candidates potentially not supporting further development or marketing approval; actions by regulatory authorities that may affect the initiation, timing, and progress of clinical trials and marketing approval for drugs; BeOne Medicines’ ability to achieve commercial success for its marketed drugs and drug candidates (if approved); BeOne Medicines’ ability to obtain and maintain intellectual property protection for its drugs and technologies; BeOne Medicines’ reliance on third parties for drug development, manufacturing, and other services; BeOne Medicines’ limited experience in obtaining regulatory approval and commercializing pharmaceutical products, as well as its ability to secure additional operating capital to complete the development of drug candidates and achieve and sustain profitability; the impact of the global COVID-19 pandemic on BeOne Medicines’ clinical development, regulatory, commercial operations, and other business activities; various risks more comprehensively discussed in the "Risk Factors" section of BeOne Medicines’ most recent quarterly report on Form 10-Q; and discussions regarding potential risks, uncertainties, and other important factors in BeOne Medicines’ subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is current only as of the date of the press release, and unless required by law, BeOne Medicines has no obligation to update such information.

Tafinlar^®、Mekinist^®、Votrient^®, Afinitor^®And Zaneka^®A registered trademark of Novartis AG