The follow-up results of the phase 2 trial indicated that BRUKINSA is unlikely to reoccur the intolerable adverse event that led to the discontinuation of the previous BTK inhibitor treatment

BRUKINSA treatment showed that 93.8% of trial participants’ disease continued to be under control, and the response improved by 64.1%

Cambridge, Massachusetts and Beijing--(BUSINESS WIRE)--(BUSINESS WIRE)--$BGNE #BGNE--BeiGene (NASDAQ: BGNE; Hong Kong Stock Exchange: 06160) is a dedicated company A global, science-driven biotechnology company that develops innovative and affordable drugs, today launched an additional ongoing Phase 2 trial evaluating BRUKINSA ® (zanubrutinib) in previously treated ibrutinib and/ Or safety and efficacy results in patients with B-cell malignancies who are intolerant to acalabrutinib. These data were reported in a small oral report at today's 63rd American Society of Hematology (ASH) annual meeting.

"We are very encouraged by these results, which further prove that BRUKINSA has the potential to benefit patients with various advanced B-cell malignancies who suffer from adverse events that other BTK inhibitors cannot tolerate," said Jane, MD and Chief Medical Officer of Hematology. Huang said. BeiGene. "BRUKINSA was purposefully designed by BeiGene scientists to reduce off-target effects by optimizing kinase selectivity, continue to inhibit BTK protein, and solve certain tolerability issues. The trial stopped using other drugs due to adverse events. The latest results obtained in patients treated with BTK inhibitors supplement the results of two phase 3 head-to-head trials comparing BRUKINSA and ibrutinib that we previously reported, in which BRUKINSA showed certain safety advantages over ibrutinib Advantage."

For more information on BeiGene's clinical program and company updates, please visit BeiGene's virtual booth at this year's ASH Annual Conference at https://www.beigenevirtualexperience.com.

Phase 2 trial of BRUKINSA in patients with R/RB cell malignancies intolerant to BTK inhibitors

This single-arm, open-label, multi-center phase 2 trial (NCT04116437) conducted in the United States evaluated the safety and effectiveness of BRUKINSA in patients with previous B-cell malignancies who had previously received BTK inhibitor treatment intolerance. The preliminary results The 62nd ASH Annual Meeting to be held in December 2020. Compared with the patient's AE profile of intolerance to ibrutinib and/or acapbutinib, the primary safety endpoint was assessed by recurrence and changes in the severity of adverse events (AE). Secondary endpoints include the investigator-assessed disease control rate (DCR), overall response rate (ORR), investigator-assessed progression-free survival (PFS), and patient-reported results.

A total of 67 patients participated in the trial, of which 57 patients were intolerant to ibrutinib (cohort 1) and 10 patients were intolerant to acalabrutinib and/or ibrutinib (cohort 2), including 43 chronic patients Patients with lymphocytic leukemia (CLL; 38 in cohort 1) and 5 in cohort 2), 11 patients with Waldenstrom's macroglobulinemia (WM; 9 in cohort 1 and 2 in cohort 2), 7 patients with small lymphocytic lymphoma (SLL; 6 in cohort 1 and 1 in cohort 2), 3 patients with mantle cell lymphoma (MCL; two in cohort 1 and one in cohort 2 ), and three patients with marginal zone lymphoma (MZL; two in cohort 1 and one in cohort 2). If a patient experiences significant or persistent toxicity during treatment with ibrutinib and/or acalabrutinib, they are considered intolerant.

"The tolerability of BTK inhibitors remains a major challenge for patients and their doctors, because treatment interruption or interruption may affect clinical outcomes. These data indicate that BRUKINSA treatment is well tolerated and is unlikely to lead to previous BTK use Recurrence of inhibitor-treated intolerant AEs,” commented Mazyar Shadman, MD, MPH, Associate Professor and Assistant Professor in the Clinical Research Department of the Fred Hutchinson Cancer Research Center. Professor of Oncology at the University of Washington and the principal investigator of the trial. "In addition, BRUKINSA is effective at least in maintaining or improving baseline treatment response, which suggests that BRUKINSA may be a treatment option for patients with hematological malignancies who are intolerant of other BTK inhibitor treatments."

As of September 8, 2021, the median exposure time of BRUKINSA was 11.1 months (11.6 months for cohort 1 and 9.8 months for cohort 2), which exceeded most ibrutinib and akabu Tinib intolerance events did not recur in BRUKINSA treatment, and no intolerance events recurred with higher severity. The safety results include:

Of the 67 patients in the two cohorts, BRUKINSA was tolerable. Additional safety results include:

The researchers evaluated the efficacy results in patients treated for more than 90 days in two cohorts. BRUKINSA can effectively maintain the response of at least 60 patients (93.8% for all patients, 94.7% for cohort 1 and 85.7% for cohort 2) or improve the baseline response of 41 patients (64.1% for all patients and 63.2% for cohort 2) . 71.4% in cohort 1 and cohort 2); the median time to first response for all patients was 2.96 months, cohort 1 was 2.92 months, and cohort 2 was 3.02 months.

BRUKINSA is a small molecule inhibitor of Bruton's tyrosine kinase (BTK) discovered by BeiGene scientists. It is currently being used as a monotherapy and combined with other therapies to treat various B-cell malignancies worldwide. to evaluate. Due to the continuous synthesis of new BTK, BRUKINSA is specifically designed to completely and continuously inhibit BTK protein by optimizing bioavailability, half-life and selectivity. Compared with other approved BTK inhibitors, BRUKINSA has different pharmacokinetic properties and has been shown to inhibit the proliferation of malignant B cells in many disease-related tissues.

BRUKINSA has obtained 12 approvals, covering 40 countries and regions:

So far, more than 20 marketing authorization applications for various indications have been submitted for BRUKINSA.

* This indication was approved under accelerated approval based on overall response rate. Continued approval for this indication may depend on the verification and description of clinical benefits in confirmatory trials.

** This indication is approved under conditional approval. Full approval of this indication may depend on the results of ongoing randomized, controlled confirmatory clinical trials.

Important U.S. Safety Information for BRUKINSA (ZANUBRUTINI)

Fatal and serious bleeding events have occurred in patients with hematological malignancies receiving BRUKINSA monotherapy. 3.4% of patients receiving BRUKINSA monotherapy reported grade 3 or higher bleeding, including intracranial and gastrointestinal bleeding, hematuria, and hemothorax. 35% of patients receiving BRUKINSA monotherapy experienced bleeding events of any grade.

Bleeding events occurred in patients with or without concurrent antiplatelet or anticoagulant therapy. Co-administration of BRUKINSA with antiplatelet or anticoagulant drugs may further increase the risk of bleeding.

Monitor for signs and symptoms of bleeding. If any grade of intracranial hemorrhage occurs, stop BRUKINSA. Depending on the type of surgery and bleeding risk, consider the benefit-risk of stopping BRUKINSA for 3-7 days before and after surgery.

Fatal and serious infections (including bacteria, viruses or fungi) and opportunistic infections have occurred in patients with hematological malignancies receiving BRUKINSA monotherapy. 27% of patients had grade 3 or higher infections, the most common being pneumonia. Infection due to reactivation of hepatitis B virus (HBV) has occurred.

Consider the prevention of herpes simplex virus, pneumocystis pneumonia, and other infections based on the standard of care for patients at increased risk of infection. Monitor and evaluate the patient’s fever or other signs and symptoms of infection, and provide appropriate treatment.

Grade 3 or 4 cytopenias, including neutropenia (26%), thrombocytopenia (11%), and anemia based on laboratory measurements (8%), occur in patients receiving BRUKINSA monotherapy . Grade 4 neutropenia occurred in 13% of patients, and grade 4 thrombocytopenia occurred in 3.6% of patients.

Monitor complete blood counts regularly during treatment, and interrupt treatment, reduce dose, or stop treatment as needed. Use growth factors or blood transfusion as needed.

14% of patients receiving BRUKINSA monotherapy developed second primary malignancies, including non-skin cancer. The most common second primary malignancy is non-melanoma skin cancer, reported in 8% of patients. Other second primary malignancies include solid malignant tumors (4.0%), melanoma (1.7%) and hematological malignancies (1.2%). It is recommended that patients use sun protection measures and monitor whether the patient has a second primary malignant tumor.

Among patients receiving BRUKINSA monotherapy, 3.2% of patients reported atrial fibrillation and atrial flutter. Patients with heart risk factors, high blood pressure, and acute infections may be at higher risk. 1.1% of patients receiving BRUKINSA monotherapy reported events of grade 3 or higher. Monitor the signs and symptoms of atrial fibrillation and atrial flutter and deal with them as appropriate.

Based on findings in animals, BRUKINSA may cause fetal harm when administered to pregnant women. Administration of zanubrutinib to pregnant rats during organ formation can cause embryo-fetal toxicity, including malformations, and the exposure is 5 times the recommended dose of 160 mg twice daily reported by the patient. Women are advised to avoid pregnancy while taking BRUKINSA and within 1 week after the last dose. Men are advised to avoid childbearing during treatment and within 1 week after the last dose.

If the drug is used during pregnancy, or if the patient becomes pregnant while taking the drug, the patient should be informed of the potential hazard to the fetus.

≥ 30% of patients receiving BRUKINSA (N = 847) The most common adverse reactions, including laboratory abnormalities, including decreased neutrophil count (54%), upper respiratory tract infection (47%), decreased platelet count (41%) ), bleeding (35%), decreased lymphocyte count (31%), rash (31%) and musculoskeletal pain (30%).

CYP3A inhibitor: When BRUKINSA is co-administered with a strong CYP3A inhibitor, reduce the BRUKINSA dose to 80 mg once a day. For co-administration with moderate CYP3A inhibitors, reduce the BRUKINSA dose to 80 mg twice daily.

CYP3A inducers: Avoid co-administration with moderate or strong CYP3A inducers.

Liver damage: The recommended dose of BRUKINSA for patients with severe liver damage is 80 mg orally twice a day.

Please view complete U.S. prescribing information at www.beigene.com/PDF/BRUKINSAUSPI.pdf and patient information at www.beigene.com/PDF/BRUKINSAUSPPI.pdf.

BeiGene is committed to advancing the best and first-class clinical drug candidates internally or with like-minded partners to develop influential and affordable drugs for patients around the world. We have a growing R&D team of approximately 2,750 colleagues and are committed to advancing more than 90 ongoing or planned clinical trials involving more than 14,000 patients and healthy volunteers. Our extensive product portfolio is mainly guided by our internal colleagues and supports clinical trials in more than 45 countries and regions. Hematology oncology, solid tumor targeted therapy and immuno-oncology are the company's key areas of focus, and single and combination therapies are prioritized in our research and development. BeiGene has currently discovered and developed three approved drugs in our own laboratory: BTK inhibitor BRUKINSA in the United States, China, the European Union, Canada, Australia and other international markets; anti-PD that binds to non-FC-γ receptors -1 Antibody tislelizumab and PARP inhibitor pamiparib are in China.

BeiGene also cooperates with innovative companies whose goal is to develop treatments to meet global health needs. We commercialized a series of oncology drugs licensed by Amgen and Bristol-Myers Squibb in China. We also plan to work with Amgen, Bio-Thera, EUSA Pharma, Mirati Therapeutics, Seagen, and Zymeworks to address larger areas of unmet needs globally. BeiGene has also reached a cooperation with Novartis, granting Novartis the right to develop, manufacture and commercialize tislelizumab in North America, Europe and Japan.

BeiGene is a science-oriented global biotechnology company focused on the development of innovative and affordable drugs to improve treatment outcomes and accessibility for patients worldwide. We have a broad product portfolio of more than 40 clinical drug candidates and are accelerating the development of our diverse new therapies through our own capabilities and cooperation. We are committed to fundamentally improving access to medicines for 2 billion people by 2030. BeiGene has a growing global team of more than 7,700 colleagues on five continents. To learn more about BeiGene, please visit www.beigene.com and follow us on Twitter @BeiGeneGlobal.

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 updated results regarding the evaluation of the Phase 2 trial of BRUKINSA (zanubrutinib) in previously treated B-cell patients Statements on malignancies that are intolerant to ibrutinib and/or acalabrutinib, the potential clinical benefits and advantages of BRUKINSA, BeiGene’s advancement plan, and BRUKINSA’s expected clinical development, regulatory milestones and commercialization, and BeiGene The plans, commitments, wishes and goals under the headings "BeiGene Oncology" and "About BeiGene". Due to various important factors, including BeiGene’s ability to prove the effectiveness and safety of its drug candidates, actual results may differ materially from the results stated in the forward-looking statements; the clinical results of its drug candidates may not support further Development or marketing approval; the actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approvals; if approved, BeiGene can achieve commercial success for its marketed drugs and drug candidates; BeiGene will be responsible for it The ability to obtain and maintain intellectual property protection for medicines and technologies; BeiGene relies on third-party services such as drug development and manufacturing; BeiGene has limited experience in obtaining regulatory approvals and commercialization of pharmaceutical products, and obtains additional operating funds , Complete the development and commercialization of drug candidates and the ability to achieve and maintain profitability; the impact of the COVID-19 pandemic on BeiGene’s clinical development, regulatory, commercial and other operations, and BeiGene’s recent report on Form 10-Q The risk more fully discussed in the section entitled "Risk Factors" in the quarterly report of BeiGene is a discussion of potential risks, uncertainties and other important factors in BeiGene's subsequent filing with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeiGene does not undertake the obligation to update such information unless required by law.

BeiGene Contact Investor Contact Gabrielle Zhou +86 10-5895-8058 ir@beigene.com Media Contact Vivian Ni +1 857-302-7596 media@beigene.com

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