BeiGene Announces Collaboration with Novartis for Development and Commercialization of Anti-PD-1 Antibody Tislelizumab (BAZAN®)

CAMBRIDGE, Mass. and BEIJING, Jan. 12, 2021 /PRNewswire/ -- BeOne Medicines (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biotechnology company focused on developing and commercializing innovative medicines globally, today announced that it has entered into a collaboration and license agreement with Novartis to develop, manufacture, and commercialize the anti-PD-1 antibody Baizean in multiple countries, including the United States, Canada, Mexico, the European Union member states, the United Kingdom, Norway, Switzerland, Iceland, Liechtenstein, Russia, and Japan.^®(tislelizumab). Both parties will, in the aforementioned countries, regarding Baizean^®conduct joint development, with Novartis responsible for regulatory submissions after the transition period and commercialization activities upon approval. In addition, both parties may conduct clinical trials globally to evaluate Baizean^®Potential combination regimens with other anti-cancer therapies; BeOne Medicines may co-commercialize the products in North America, with Novartis providing a portion of the operational funding.

BAIZEAN^®is a humanized IgG4 anti-PD-1 monoclonal antibody, designed to minimize its binding to FcγR receptors in macrophages. In China, Baizean^®Two indications have been approved and commercialized by BeOne Medicines: classical Hodgkin lymphoma (cHL) after at least two prior lines of therapy, and locally advanced or metastatic urothelial carcinoma (UC) with high PD-L1 expression. In addition, three other indications for Baizean^®The marketing application for the new indications has been accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA), including an indication in combination with chemotherapy for the first-line treatment of patients with advanced squamous non-small cell lung cancer (NSCLC), an indication in combination with chemotherapy for the first-line treatment of patients with advanced non-squamous NSCLC, and an indication for the treatment of patients with previously treated unresectable hepatocellular carcinoma.

John V. Oyler, Co-founder, Chairman and Chief Executive Officer of BeOne Medicines, stated: “We are pleased to collaborate with Novartis to further advance Baizean^®Evaluating multiple combination therapy regimens and the potential for indication expansion. Novartis, with its unique oncology product portfolio and R&D pipeline, is a recognized leader in the field of oncology. Baizean^®Baizean has an extensive global R&D program, with two indications already approved in China. Currently, 15 potential registrational clinical trials are underway, having enrolled more than 7,700 patients worldwide to date, including approximately 2,500 patients from 20 countries and regions outside mainland China.^®“Extensive global development programs have laid a solid foundation for this important collaboration. We look forward to working with Novartis to bring this potentially differentiated anti-PD-1 antibody to the global market.”

Under the agreement, BeOne Medicines will receive a $650 million upfront payment and will be eligible for up to $1.3 billion in payments upon achieving registration milestones, $250 million in payments upon achieving sales milestones, as well as eligibility for Tevima^®Royalties on future sales in the licensed territory. Under the agreement, BeOne Medicines will be responsible for the ongoing development of Baizean^®Novartis will fund newly initiated registration-enabling, bridging, or post-marketing studies in the licensed territories, with each party responsible for funding its own assessments of Baizean.^®Provide funding for clinical trials involving combination therapies with company-owned or third-party drugs. Both parties will retain the right to independently develop their respective products in combination with Baizean.^®Global commercialization rights for the drug combination.

The completion of this transaction is subject to the expiration or early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act.

BeOne Medicines to Present at J.P. Morgan Healthcare Conference

BeOne Medicines to Attend the 39th Annual J.P. Morgan Healthcare Conference and Deliver a Presentation on Thursday, January 14, 2021, at 5:20 p.m. Eastern Time (6:20 a.m. Beijing Time on January 15)

At that time, the Investor Relations section of BeOne Medicines’ official website (http://ir.beigene.com or http://hkexir.beigene.com) will provide a live webcast of the presentation. A replay of the webcast will be archived and available for viewing within 90 days after the conference.

About Baizean^®(Tislelizumab Injection)

Baizean^®(Tislelizumab Injection) is a humanized IgG4 monoclonal antibody against programmed death receptor 1 (PD-1), designed to minimize binding to FcγR receptors in macrophages. Preclinical data indicate that binding to FcγR receptors in macrophages activates antibody-dependent cell-mediated cytotoxicity of T cells, thereby reducing the antitumor activity of PD-1 antibodies. Baizean^®It is the first drug developed by BeOne Medicines’ immuno-oncology biologics platform, currently undergoing clinical trials as a monotherapy and in combination regimens to develop a broad range of indications for solid tumors and hematologic malignancies.

China's National Medical Products Administration (NMPA) has granted approval to Baizean^®Conditionally approved for the treatment of the following indications: patients with relapsed or refractory classical Hodgkin lymphoma who have received at least two prior lines of systemic chemotherapy, and patients with locally advanced or metastatic urothelial carcinoma with high PD-L1 expression whose disease has progressed during or within 12 months of platinum-containing chemotherapy, including neoadjuvant or adjuvant chemotherapy. Full approval for these indications will be contingent upon the results of ongoing confirmatory randomized controlled clinical trials.

Furthermore, the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has accepted the application for Baizean.^®three new indications for marketing approval are currently under review, including one for the treatment of patients with previously treated unresectable hepatocellular carcinoma, one in combination with chemotherapy for the first-line treatment of patients with advanced squamous non-small cell lung cancer (NSCLC), and another in combination with chemotherapy for the first-line treatment of patients with advanced non-squamous NSCLC.

Currently, there are a total of 15 items of Baizean.^®Registrational clinical trials have been conducted in China and globally, including 13 Phase 3 clinical trials and 2 pivotal Phase 2 clinical trials.

BAIZEAN^®Not yet approved in countries and regions outside China.

About Baizean^®(Clinical Development Program for Tislelizumab Injection)

Clinical trials of tislelizumab include:

About BeOne Medicines

BeOne Medicines is a global, commercial-stage biotechnology company dedicated to researching, developing, manufacturing, and commercializing innovative medicines to improve therapeutic outcomes and drug accessibility for patients worldwide. Currently employing more than 5,000 people across mainland China, the United States, Australia, Europe, and other regions, BeOne Medicines is accelerating the advancement of its diversified pipeline of novel cancer therapies. At present, two of the company’s independently developed drugs, including the BTK inhibitor Brukinsa^®(Zanubrutinib Capsules) are being sold in the United States and China; anti-PD-1 antibody drug Baizean^®(Tislelizumab Injection) is marketed in China. In addition, BeOne Medicines is currently marketing or plans to market in China a portfolio of oncology drugs licensed from Amgen, Celgene Corporation (a subsidiary of Bristol-Myers Squibb), and EUSA Pharma. For more information, please visit www.beigene.com.cn.

Forward-Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including those related to Baizean^®Future development, anticipated clinical development, regulatory milestones and commercialization progress, the commitments of both parties, the potential benefits of this collaboration, as well as the conditions precedent to and expected timing for the completion of this transaction. Due to the influence of various significant factors, actual results may differ materially from those expressed in forward-looking statements. These factors include risks related to: BeOne Medicines’ ability to demonstrate the efficacy and safety of its drug candidates; the possibility that clinical results for drug candidates may not support further development or regulatory approval; actions by regulatory authorities that may affect the initiation, timeline, and progress of clinical trials as well as product marketing approvals; BeOne Medicines’ ability to achieve commercial success for its marketed products and drug candidates (if approved); BeOne Medicines’ ability to obtain and maintain intellectual property protection for its technologies and drugs; BeOne Medicines’ reliance on third parties for drug development, manufacturing, and other services; BeOne Medicines’ limited operating history and its ability to secure additional operating funds to complete the development and commercialization of its drug candidates; the impact of the global COVID-19 pandemic on the Company’s clinical development, commercial operations, and other business activities; and the various risks more fully discussed in the “Risk Factors” section of BeOne Medicines’ most recent Quarterly Report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in subsequent filings made by BeOne Medicines with the U.S. Securities and Exchange Commission. All information contained in this press release is current only as of the date of this press release, and BeOne Medicines undertakes no obligation to update such information except as required by law.