BeiGene announced that the FDA has extended the PDUFA target date for Baiyueze's ® application for marketing authorization for new indications for the treatment of CLL/SLL

After BeiGene submitted to the FDA supplementary data on the Total Response Rate (ORR) of Ibertinib ® confirmed by the Independent Review Committee (IRC), the FDA extended the target review date for the Prescription Drug Declarant Fees Act (PDUFA) for the listing application to January 20, 2023, in order to ensure sufficient review time

Beijing, China, Cambridge, Massachusetts, USA, and Basel, Switzerland June 13, 2022 /PRNewswire/ -- BeiGene (NASDAQ: BGNE; HKEx Code: 06160; SSE Code: 688235) is a global biotechnology company based on science, focused on the development of innovative, affordable medicines that aim to improve treatment outcomes and access to patients worldwide. The U.S. Food and Drug Administration (FDA) today announced that the U.S. Food and Drug Administration (FDA) extended its Prescription Drug Declarant Fee Act (PDUFA) target review date by three months to January 20, 2023, for ® a new indication for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

The FDA extended the PDUFA target date for the application to conduct a full review of additional clinical data submitted by BeiGene. Additional clinical data submitted by BeiGene was identified as an important addition to the sNDA. These reports include the final response assessment of the Phase 3 ALPINE clinical trial worldwide, which showed that, as assessed by IRC, Itabisoft ® demonstrated an overall response rate (ORR) of ibutinib in adult patients with relapse/refractory (R/R) CLL or SLL. Previously, BeiGene published the final mitigation assessment results of the trial on April 11, 2022.

John V. Oyler, Co-Founder, Chairman and CEO of BeiGene, said, "We will continue to work closely with the FDA to further advance the review of The SNDA used by Baiyueze ® for the treatment of CLL/SLL. The submitted data demonstrates the potential of Joyson in ® the treatment of CLL/SLL, and we are confident about it. After receiving relevant marketing approvals in the future, we will also work to bring this important therapeutic drug to CLL/SLL patients in the United States as soon as possible." "

The sNDA nomination for CLL/SLL is based on data from two critical, randomized Phase 3 clinical trials and eight supporting trials in B-cell malignancies. Among them, the two global Phase 3 trials of Baiyueze ® for the treatment of CLL/SLL were: SEQUOIA clinical trial (NCT03336333), which compared Baiyueze ® with bendamustine combined with rituximab for the treatment of patients with initial treatment (TN); Alpine (NCT03734016) clinical trial comparing Bolsoze ® versus ibutinib for the treatment of patients with relapse/refractory (R/R). In addition, non-randomized patients with 17p deficiency were enrolled in the SEQUOIA clinical trial to evaluate the efficacy of Baiyueze ® in monotherapy for this high-risk population. The two studies enrolled patients from 17 countries, including the United States, several European countries, China, Australia and New Zealand. The results of the interim analysis of the ALPINE trial and the SEQUOIA trial were presented at the 26th European Haematology Association (EHA 2021) Online Annual Meeting in June 2021 and the 63rd Annual Meeting of the American Society of Hematology (ASH) in December 2021, respectively.

concerning ALPINE clinical trial

ALPINE is a randomized, global Phase 3 clinical trial (NCT03734016) to evaluate the efficacy of Baiyueze ® versus ibutinib in the treatment of patients with previously treated relapsed/refractory chronic lymphocytic leukemia (CLL)/micro-lymphocytic lymphoma (SLL). In the trial, 652 patients were randomly divided into two groups, one group receiving Baiyueze ® (160 mg orally twice daily) and the other receiving ibutinib (420 mg orally once daily) until the patient developed disease progression or unacceptable toxicity. In a major analysis of the overall response rate (ORR), investigators and the Independent Review Committee (IRC) assessed response in patients with CLL based on the International Working Group on Chronic Lymphocytic Leukemia (iwCLL) Guidelines (revised 2008 revision), and lugano non-Hodgkin lymphoma classification criteria to assess response in patients with SLL. OrRs assessed by investigators and IRC are graded, first assessing non-inferiority and then efficacy. Key secondary endpoints included progression-free survival (PFS) and incidence of atrial fibrillation or atrial flutter events; Other secondary endpoints included duration of response (DoR), overall survival (OS), and adverse event incidence. The study is ongoing and a formal analysis of PFS is planned when the target number of events is reached.

About Baiyueze

®

Bloton's ® tyrosine kinase (BTK) small molecule inhibitor independently developed by BeiGene scientists is currently undergoing extensive clinical trials worldwide as a single agent and in combination with other therapies to treat multiple B-cell malignancies. Because new BTKs are synthesized in the human body, Baiyueze's ® design achieves complete and continuous inhibition of BTK protein by optimizing bioavailability, half-life and selectivity. With pharmacokinetics that differentiate it from other approved BTK inhibitors, Baiyueze ® can inhibit the proliferation of malignant B cells in multiple disease-related tissues. Baiyueze ® has been approved for the treatment of three indications in the United States: In November 2019, it was approved for the treatment of adult patients with sleeve cell lymphoma (MCL) who had received at least one treatment before; In August 2021, it was approved for the treatment of adult patients with Fahrenhet macroglobulinemia (WM); Approved in September 2021 for the treatment of adult patients with relapsed/refractory borderline lymphoma who have previously received at least one type of anti-CD20 therapy*. Baiyueze ® has carried out a wide range of global clinical development projects, and has conducted 35 trials in 28 markets around the world, with a total enrollment of more than 3,900 subjects. To date, Baiyueze ® has been approved in 50 countries and regions including the United States, China, the European Union and the United Kingdom, Canada, Australia, South Korea, Switzerland and other international markets.

*This indication is approved expedited based on the overall response rate (ORR). Subsequent formal approval for this indication will depend on the validation and description of clinical benefit in confirmatory trials.

About BeiGene

BeiGene is a global science-based biotechnology company focused on developing innovative, affordable medicines designed to improve outcomes and access to medicines for patients around the world. The company's extensive drug portfolio currently includes more than 40 clinical drug candidates. By strengthening its independent R&D capabilities and cooperation, the company has accelerated the development of diversified and innovative drug pipelines. We are committed to improving access to medicines across the board for more than 2 billion people worldwide by 2030. BeiGene has built a team of more than 8,000 people on five continents. For more information, please visit.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including data on the global Phase 3 clinical trial ALPINE, The Potential of Baiyueze ® to Treat Patients with CLL/SLL, and the FDA's Expected Review and Approval Of the sNDA used by Baiyueze ® to treat CLL/SLL, As soon as possible after approval of the listing, BeiGene will advance the possibility of Baiyueze ® for the treatment of CLL/SLL patients, The expected clinical development, pharmaceutical policy milestones and commercialization process of Baiyueze ®, and the plans, commitments, ambitions and goals of BeiGene referred to under the heading "About BeiGene". Actual results may differ materially from forward-looking statements due to a variety of important factors. These factors include the risk of: BeiGene's ability to demonstrate the efficacy and safety of its drug candidates; Clinical outcomes of drug candidates may not support further development or marketing approval; Actions by the Pharmaceutical Administration may affect the initiation, timeline and progress of clinical trials and the approval of drug marketing; BeiGene's ability to commercially successfully marketed and drug candidates, if approved; BeiGene's ability to obtain and maintain intellectual property protection for its drugs and technologies; BeiGene's reliance on third parties for drug development, production and other services; BeiGene has limited experience in regulatory approvals and commercialization of pharmaceutical products, as well as its ability to secure further working capital to complete drug candidate development and commercialization and to achieve and remain profitable; The impact of the COVID-19 pandemic on Clinical Development, Regulation, Commercial Operations, Production and Other Businesses in Be in BeiGene; and the types of risks that BeiGene discussed more fully in the "Risk Factors" section of the Most recent Quarterly Report; and discussions of potential risks, uncertainties, and other important factors in BeiGene's post-period filing with the SEC. All information in this press release is limited to the date of publication of this press release and BeiGene has no obligation to update such information except as required by law.