Item 8.01. Other Events.
On November 23, 2021, the Company issued a press release announcing the launch of the STAR Offering. A copy of this press release is attached hereto as Exhibit 99.1, and is incorporated herein by reference.
On November 23, 2021, the Company issued a press release announcing that the European Commission (EC) approved BRUKINSA® (zanubrutinib) for the treatment of adult patients with Waldenström’s macroglobulinemia (WM) who have received at least one prior therapy or for the first-line treatment of patients unsuitable for chemo-immunotherapy. The approval is applicable to all 27 European Union (EU) member states, plus Iceland and Norway. A copy of this press release is attached hereto as Exhibit 99.2, and is incorporated herein by reference.
On November 23, 2021, the Company announced that it has purchased a 42-acre site at the Princeton West Innovation Campus in Hopewell, N.J. to house a new state-of-the-art manufacturing campus and clinical R&D center. As a key part of BeiGene’s continued growth, the company is investing in U.S. manufacturing to further expand and diversify its global supply chain and build new manufacturing capabilities for its deep pipeline of biologic and drug candidates. A copy of this press release is attached hereto as Exhibit 99.3, and is incorporated herein by reference.
On November 22, 2021, the Company announced that the first patient has been dosed in a Phase 1 clinical trial of BGB-23339, a potent, allosteric investigational tyrosine kinase 2 (TYK2) inhibitor internally developed by BeiGene scientists. A copy of this press release is attached hereto as Exhibit 99.4, and is incorporated herein by reference.
On November 19, 2021, the China National Medical Products Administration approved POBEVCY® (a biosimilar to bevacizumab injection) for the treatment of patients with advanced, metastatic or recurrent non-small cell lung cancer (NSCLC) and metastatic colorectal cancer. BeiGene has rights to develop, manufacture, and commercialize POBEVCY® in China (including Hong Kong, Macao and Taiwan) under a collaboration agreement with Bio-Thera Solutions, Ltd. entered in August 2020.
Forward-Looking Statements
This Current Report on Form 8-K contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other securities laws, including statements regarding the Proposed Issue of RMB Shares under the general mandate to be listed on the STAR Market. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including the possibility that the conditions, including market conditions and customary closing conditions related to the STAR Offering, will not be met and that BeiGene will be unable to consummate the Proposed Issue of RMB Shares; the possibility that BeiGene will not realize the expected benefits of the transaction; the possibility that the final financial performance data will be different from the preliminary data; BeiGene's ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; BeiGene's ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeiGene's ability to obtain and maintain protection of intellectual property for its medicines and technology; BeiGene's reliance on third parties to conduct drug development, manufacturing and other services; BeiGene’s limited experience in obtaining regulatory approvals and commercializing pharmaceutical products and its ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates and achieve and maintain profitability; the impact of the COVID-19 pandemic on the BeiGene’s clinical development, regulatory, commercial, and other operations, as well as those risks more fully discussed in the section entitled “Risk Factors” in BeiGene’s most recent quarterly report on Form 10-Q as well as discussions of potential risks, uncertainties, and other important factors in BeiGene's subsequent filings with the U.S. Securities and Exchange Commission. All information in this Current Report is as of the date of this Current Report, and BeiGene undertakes no duty to update such information unless required by law.
The Proposed Issue of RMB Shares under the general mandate is subject to, among other things, market conditions and customary closing conditions related to the STAR Offering, and thus may or may not proceed. Shareholders and potential investors of the Company should be aware that there is no assurance that the Proposed Issue of RMB Shares will complete or as to when it may complete. Shareholders and potential investors of the Company should exercise caution when dealing in the securities of the Company.
Further announcement(s) or filings will be made by the Company in accordance with the applicable laws and regulations on any material updates and progress in connection with the Proposed Issue of RMB Shares as and when appropriate. This announcement is for information purposes only and does not constitute any invitation or offer to acquire, purchase or subscribe for the securities of the Company.