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China National Medical Products Administration Approves Tislelizumab in Combination with Chemotherapy in First-Line Advanced Squamous Non-Small Cell Lung Cancer

BEIJING & CAMBRIDGE, Mass.–(BUSINESS WIRE)–$BGNE #BGNE–BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biotechnology firm targeted on growing and commercializing revolutionary medicines worldwide, right now introduced that its anti-PD-1 antibody tislelizumab has obtained approval from the China Nationwide Medical Products Administration (NMPA) to be used together with two chemotherapy regimens as a first-line therapy for sufferers with superior squamous non-small cell lung most cancers (NSCLC). That is the third approval in China for tislelizumab, and its first in a lung most cancers indication.

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“This approval for tislelizumab is a vital milestone for BeiGene, for tislelizumab, and for the sufferers and healthcare practitioners in China combating superior squamous NSCLC,” commented Xiaobin Wu, Ph.D., Normal Supervisor of China and President of BeiGene. “That is our sixth international approval for an internally-developed product, and our first approval for tislelizumab in a lung most cancers indication, an space the place we consider tislelizumab can have a big influence for sufferers.”

“With the latest announcement that the RATIONALE 303 trial met its main endpoint of general survival at its interim evaluation, three Section 3 trials of tislelizumab in NSCLC have achieved a optimistic final result at interim evaluation,” commented Yong (Ben) Ben, M.D., Chief Medical Officer, Immuno-Oncology at BeiGene. “Tislelizumab is being investigated in a broad medical program, together with 5 Section 3 trials in lung most cancers indications. We consider that it is a vital immunotherapy and demonstrates our work at BeiGene to convey revolutionary, impactful, and high quality remedies to sufferers in want.”

“Lung most cancers is the main reason for cancer-related loss of life in China, and with NSCLC comprising the commonest type of the illness, there may be vital affected person want. We’re grateful to have a brand new therapy out there within the front-line setting for sufferers with superior squamous non-small cell lung most cancers,” stated Jie Wang, M.D., Ph.D., Nationwide Most cancers Heart/Most cancers Hospital, Chinese language Academy of Medical Sciences & Peking Union Medical School. “In its Section 3 trial on this indication, tislelizumab, mixed with normal chemotherapy demonstrated a clinically significant profit as assessed by progression-free survival and response charges.”

“The approval of tislelizumab for sufferers with superior squamous NSCLC was made doable by the brave sufferers who participated within the trial, the devoted clinicians who helped conduct the trial, and our hard-working workforce at BeiGene. We’re humbled by the expeditious review of our supplemental new drug utility and hope our broad improvement program for tislelizumab will proceed its momentum and profit further sufferers,” stated Wendy Yan, Senior Vice President and World Head of Regulatory Affairs at BeiGene.

The approval of tislelizumab for the therapy of sufferers with superior squamous NSCLC was supported by medical outcomes from a Section 3 trial of tislelizumab mixed with both paclitaxel and carboplatin or nab-paclitaxel (ABRAXANE®) and carboplatin in comparison with paclitaxel and carboplatin alone in sufferers with untreated stage IIIB or IV squamous NSCLC from mainland China (NCT03594747). A complete of 360 sufferers have been randomized 1:1:1 to obtain tislelizumab together with both chemotherapy routine or chemotherapy alone. As introduced in January 2020, the trial met the first endpoint of statistically vital enchancment in progression-free survival (PFS), as assessed by unbiased review committee (IRC), within the pre-planned interim evaluation. The protection profile of tislelizumab in each combos was in line with the recognized dangers of every research therapy, and no new security alerts have been recognized. The results of the interim analysis of the trial have been introduced on the 2020 American Society of Scientific Oncology (ASCO) Digital Scientific Program.

About Non-Small Cell Lung Most cancers

In distinction to most Western nations, the place lung most cancers loss of life charges are reducing, the lung most cancers incidence charge continues to be rising in China.i,ii There have been roughly 815,563 new circumstances of lung most cancers in China in 2020 and it’s the main reason for cancer-related loss of life in each women and men, with roughly 714,699 deaths in China in 2020.iii Non-small cell lung most cancers (NSCLC) is the commonest type of lung most cancers, accounting for about 80 to 85 p.c of all case.iv

About Tislelizumab

Tislelizumab (BGB-A317) is a humanized IgG4 anti-PD-1 monoclonal antibody particularly designed to reduce binding to FcγR on macrophages. In pre-clinical research, binding to FcγR on macrophages has been proven to compromise the anti-tumor exercise of PD-1 antibodies by means of activation of antibody-dependent macrophage-mediated killing of T effector cells.v Tislelizumab is the primary drug from BeiGene’s immuno-oncology biologics program and is being developed internationally as a monotherapy and together with different therapies for the therapy of a broad array of each stable tumor and hematologic cancers.

The China Nationwide Medical Products Administration (NMPA) has granted tislelizumab full approval for first-line therapy of sufferers with superior squamous non-small cell lung most cancers (NSCLC) together with chemotherapy. Tislelizumab has additionally obtained conditional approval from the NMPA for the therapy of sufferers with classical Hodgkin’s lymphoma who obtained not less than two prior therapies and for the therapy of sufferers with domestically superior or metastatic urothelial carcinoma with PD-L1 excessive expression whose illness progressed throughout or following platinum-containing chemotherapy or inside 12 months of neoadjuvant or adjuvant therapy with platinum-containing chemotherapy. Full approval for these indications is contingent upon outcomes from ongoing randomized, managed confirmatory medical trials.

As well as, two supplemental new drug functions for tislelizumab have been accepted by the Heart for Drug Analysis (CDE) of the NMPA and are underneath evaluate for first-line therapy of sufferers with superior non-squamous NSCLC together with chemotherapy, and for beforehand handled unresectable hepatocellular carcinoma.

At the moment, 15 probably registration-enabling medical trials are being performed in China and globally, together with 13 Section 3 trials and two pivotal Section 2 trials.

Tislelizumab is just not accredited to be used outdoors of China.

About Tislelizumab Scientific Program

Scientific trials of tislelizumab embody:

  • Section 3 trial evaluating tislelizumab to salvage chemotherapy in sufferers with relapsed/refractory classical Hodgkin Lymphoma (NCT04486391);
  • Section 3 trial in sufferers with domestically superior or metastatic urothelial carcinoma (NCT03967977);
  • Section 3 trial evaluating tislelizumab with docetaxel within the second- or third-line setting in sufferers with NSCLC (NCT03358875);
  • Section 3 trial of tislelizumab together with chemotherapy versus chemotherapy as first-line therapy for sufferers with superior squamous NSCLC (NCT03594747);
  • Section 3 trial of tislelizumab together with chemotherapy versus chemotherapy as first-line therapy for sufferers with superior non-squamous NSCLC (NCT03663205);
  • Section 3 trial of tislelizumab together with platinum-based doublet chemotherapy as neoadjuvant therapy for sufferers with NSCLC (NCT04379635);
  • Section 3 trial of tislelizumab mixed with platinum and etoposide versus placebo mixed with platinum and etoposide in sufferers with extensive-stage small cell lung most cancers (NCT04005716);
  • Section 3 trial evaluating tislelizumab with sorafenib as first-line therapy for sufferers with hepatocellular carcinoma (HCC; NCT03412773);
  • Section 2 trial in sufferers with beforehand handled unresectable HCC (NCT03419897);
  • Section 3 trial evaluating tislelizumab with chemotherapy as second-line therapy for sufferers with superior esophageal squamous cell carcinoma (ESCC; NCT03430843);
  • Section 3 trial of tislelizumab together with chemotherapy as first-line therapy for sufferers with ESCC (NCT03783442);
  • Section 3 trial of tislelizumab versus placebo together with chemoradiotherapy in sufferers with localized ESCC (NCT03957590);
  • Section 3 trial of tislelizumab mixed with chemotherapy versus placebo mixed with chemotherapy as first-line therapy for sufferers with gastric most cancers (NCT03777657);
  • Section 2 trial in sufferers with MSI-H/dMMR stable tumors (NCT03736889); and
  • Section 3 trial of tislelizumab mixed with chemotherapy versus placebo mixed with chemotherapy as first-line therapy in sufferers with nasopharyngeal most cancers (NCT03924986).

About BeiGene

BeiGene is a world, commercial-stage biotechnology firm targeted on discovering, growing, manufacturing, and commercializing revolutionary medicines to enhance therapy outcomes and entry for sufferers worldwide. Our 5,000+ staff in China, the US, Australia, Europe, and elsewhere are dedicated to expediting the event of a various pipeline of novel therapeutics. We at present market two internally found oncology merchandise: BTK inhibitor BRUKINSA® (zanubrutinib) in the US and China, and anti-PD-1 antibody tislelizumab in China. We additionally market or plan to market in China further oncology merchandise licensed from Amgen Inc., Celgene Logistics Sàrl, a Bristol Myers Squibb (BMS) firm, and EUSA Pharma. To be taught extra about BeiGene, please go to www.beigene.com and observe us on Twitter at @BeiGeneUSA.

Ahead-Wanting Statements

This press release accommodates forward-looking statements throughout the which means of the Non-public Securities Litigation Reform Act of 1995 and different federal securities legal guidelines, together with statements concerning BeiGene’s additional development of, and anticipated medical improvement, regulatory milestones and commercialization of tislelizumab. Precise outcomes could differ materially from these indicated within the forward-looking statements because of numerous vital elements, together with BeiGene’s capacity to exhibit the efficacy and security of its drug candidates; the medical outcomes for its drug candidates, which can not help additional improvement or advertising approval; actions of regulatory businesses, which can have an effect on the initiation, timing and progress of medical trials and advertising approval; BeiGene’s capacity to attain business success for its marketed merchandise and drug candidates, if accredited; BeiGene’s capacity to acquire and preserve safety of mental property for its expertise and medicines; BeiGene’s reliance on third events to conduct drug improvement, manufacturing and different services; BeiGene’s restricted working historical past and BeiGene’s capacity to acquire further funding for operations and to finish the event and commercialization of its drug candidates; and the influence of the COVID-19 pandemic on the Firm’s medical improvement, business and different operations, in addition to these dangers extra absolutely mentioned within the part entitled “Danger Components” in BeiGene’s most up-to-date quarterly report on Type 10-Q, in addition to discussions of potential dangers, uncertainties, and different vital elements in BeiGene’s subsequent filings with the U.S. Securities and Change Fee. All data on this press release is as of the date of this press launch, and BeiGene undertakes no obligation to replace such data except required by legislation.

ABRAXANE® is a registered trademark of Abraxis Bioscience LLC, a Bristol-Myers Squibb firm.


i Jemal A, Bray F, Heart MM, et al. World most cancers statistics. CA Most cancers J Clin 2011;61:69-90.

ii She J, Yang P, Hong Q, et al. Lung most cancers in China: challenges and interventions. Chest 2013;143:1117-26.

iii The World Most cancers Observatory. Accessible at https://gco.iarc.fr/today/data/factsheets/populations/160-china-fact-sheets.pdf. Accessed December 2020.

iv American Most cancers Society. Accessible at https://www.cancer.org/cancer/lung-cancer/about/what-is.html#:~:text=About%2080%25%20to%2085%25%20of,(outlook)%20are%20often%20similar. Accessed December 2020.

v Zhang, T., Tune, X., Xu, L., Ma, J., Zhang, Y., Gong, W., Zhang, Y., Zhou, X., Wang, Z., Wang, Y., Shi, Y., Bai, H., Liu, N., Yang, X., Cui, X., Cao, Y., Liu, Q., Tune, J., Li, Y., Tang, Z., … Li, Okay. (2018). The binding of an anti-PD-1 antibody to FcγRΙ has a profound influence on its organic features. Most cancers immunology, immunotherapy : CII, 67(7), 1079–1090. https://doi.org/10.1007/s00262-018-2160-x

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