BeiGene Announces Temporary Supply Disruption of ABRAXANE® (paclitaxel protein-bound particles for injectable suspension, albumin-bound) in China

Beijing, China and Cambridge, Massachusetts, USA, March 25, 2020 /PRNewswire/ -- BeOne Medicines (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on the development and commercialization of innovative molecularly targeted and tumor immunology drugs for cancer treatment, announced today that it has learned of the National Medical Products Administration's decision to suspend the import, sale, and use of Celgene Corporation’s (now part of Bristol-Myers Squibb) paclitaxel for injection (albumin-bound) products. This decision was based on the inspection results of a contract manufacturing organization located in the United States affiliated with Bristol-Myers Squibb. BeOne Medicines anticipates that this will impact ABRAXANE^®Supply in China has been temporarily interrupted. The company is working closely with Bristol-Myers Squibb to restore supply as soon as possible, including Bristol-Myers Squibb’s remediation efforts at the existing manufacturing site and its submission of an application to use another manufacturing facility to supply the Chinese market.

Mr. John Oyler, Founder, Chief Executive Officer, and Chairman of BeOne Medicines, stated, “As ABRAXANE^®"As the sales agent in China, we are deeply disappointed by this supply disruption. At BeOne Medicines, drug quality is of paramount importance. We hold ourselves and our partners to the highest industry standards. We are currently communicating with Bristol-Myers Squibb to implement corrective actions as soon as possible. Meanwhile, we will continue to focus on the commercial launch activities of BeOne Medicines’ independently developed products and other offerings in China and the United States, as well as the development of potential new therapies for patients worldwide."

BeOne Medicines and Celgene (now part of Bristol-Myers Squibb) signed ABRAXANE in 2017^®and the exclusive license and supply agreements for two other products in China. Under this agreement, BeOne Medicines is responsible for the promotion and sales of the product in China, while Bristol-Myers Squibb is responsible for manufacturing, maintaining registration and import licenses in compliance with regulatory requirements, and supplying finished formulations for the Chinese market.

In addition to the ongoing rectification of existing contract manufacturing organizations, Bristol-Myers Squibb has submitted a supplemental application to the National Medical Products Administration to change the manufacturing site, aiming to supply the Chinese market from another of its facilities. The application is currently under review.

The National Medical Products Administration’s investigation findings regarding Bristol-Myers Squibb’s contract manufacturing organization will not affect any other products marketed by BeOne Medicines. Furthermore, this contract manufacturing organization does not manufacture any other products marketed by BeOne Medicines.

About ABRAXANE^®For the manufacturing of Paclitaxel for Injection (Albumin-Bound) and other inquiries regarding Bristol-Myers Squibb, please contactmedia@bms.comOr call +1 609-252-3345.

About BeOne Medicines

BeOne Medicines is a global, commercial-stage, R&D-driven biotechnology company focused on the development of molecularly targeted and immuno-oncology therapies. Currently employing over 3,500 people across mainland China, the United States, Australia, and Europe, BeOne Medicines maintains a pipeline that includes novel oral small-molecule anticancer drugs and monoclonal antibodies. The company is also building combination regimens for cancer treatment, aiming to make a sustained and profound impact on the lives of cancer patients. BeOne Medicines markets its internally developed BTK inhibitor, BRUKINSA™ (zanubrutinib), in the United States, and sells its PD-1 antibody drug, Baizean, in China.^®(Tislelizumab Injection). Under the authorization of Celgene Logistics Co., Ltd. (a subsidiary of Bristol-Myers Squibb Company), BeOne Medicines sells ABRAXANE in China.^®Paclitaxel for Injection (Albumin-bound), Revlimid^®(Lenalidomide) and Vidaza^®(Azacitidine for Injection)^[1]; Under license from Amgen, BeOne Medicines plans to sell Xgeva in China^®（XGEVA^®) Denosumab Injection^[2]. For more information, please visitwww.beigene.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 those related to ABRAXANE^®supply disruptions in China, measures to restore supply as soon as possible, and that BeOne Medicines will continue to develop and launch other products. Due to the influence of various important factors, actual results may differ materially from forward-looking statements. These factors include risks related to: Bristol-Myers Squibb’s and its contract manufacturing organizations’ ability to successfully remediate existing production facilities, or Bristol-Myers Squibb’s ability to obtain approval for alternative production facilities; inspections by the National Medical Products Administration (NMPA) of the production facilities to be used by Bristol-Myers Squibb; and the NMPA’s reinstatement of Bristol-Myers Squibb’s importation, sale, and use of ABRAXANE in China^®approvals; 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, progress, and approval for marketing of clinical trials; BeOne Medicines’ ability to achieve commercial success for its marketed products and drug candidates (if approved); BeOne Medicines’ ability to obtain and maintain protection for its technology and drug intellectual property rights; 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 capital to complete the development and commercialization of its drug candidates; the impact of the novel coronavirus on the Company’s clinical development, commercial activities, and other business operations; and various risks more fully discussed in the “Risk Factors” section of BeOne Medicines’ most recent Annual Report on Form 10-K, as well as discussions of 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 issuance, and BeOne Medicines assumes no obligation to update such information unless required by law.

[1] Paclitaxel for Injection (Albumin-Bound)^®Registered trademark of Abraxis LLC (a subsidiary of Bristol-Myers Squibb Company): Revlimid^®and Vidaza^®® is a registered trademark of Celgene Corporation (a Bristol-Myers Squibb Company).

[2] Angiav^®（XGEVA^®) is a registered trademark of Amgen Inc.