China National Drug Administration (NMPA) Approval of Baizean(tirelizumab) new indications for gastric cancer

BEIJING, April 30, 2024/PRNewswire/ -- BeiGene (NASDAQ: BGNE; Hong Kong Stock Exchange: 06160; Shanghai Stock Exchange: 688235), a global cancer treatment innovation company, announced today that its PD-1 inhibitor Baizean(tirelizumab) officially obtainedChina's National Drug Administration (China Drug Administration) approved the combination of fluorouracil and platinum chemotherapy for locally advanced unresectable or metastatic gastric or gastroesophageal joints (G/GEJ) First-line treatment for adenocarcinoma.

This approval is based on the final analysis results of the RATIONALE-305 test (NCT03777657). This result is alsoSet a new survival record for advanced gastric cancer for the entire global population and the Chinese populationIt shows that among the global intentional treatment (ITT) population, the median overall survival (MoS) of the tirelizumab combination chemotherapy group reached 15.0 months, significantly reducing the risk of death by 20%. Among them, the MoS of the Chinese population reached 15.7 months.

Previously, in February 2023, tirelizumab was approved for first-line treatment of locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma with high PD-L1 expression in combination with fluorouracil and platinum agents (click here to learn more). This approval further validates that regardless of PD-L1 expression, tilaserizumab combined with chemotherapy as a first-line treatment for advanced gastric cancer can benefit patients.

Gastric cancer is the fifth most common malignant tumor in China. New cases of gastric cancer in China account for about 40% of the world's new gastric cancer cases^{[i], [ii]}. Adenocarcinoma is the main histologic subtype of gastric cancer^[iii]. More than 70% of new cases of gastric cancer in China are advanced or advanced at the time of diagnosis^[iv]In the past, the effects of chemotherapy as a first-line standard treatment still need to be improved. The patient's MoS is only 1 year^[v]. A variety of new treatment options, including immunotherapy, are continuing to improve survival outcomes for advanced gastric cancer patients in China^[vi].

Head of Global R&D at BeiGeneWang Lai“Advanced gastric cancer is still one of the leading causes of death among cancer patients in China,” the doctor said. We believe that after approval, a wider range of gastric cancer patients will receive immunotherapy options, and we expect tirelizumab to bring more survival benefits to cancer patients. As a global innovative oncology treatment company, BeiGene will continue to respect its original intention to provide accessible and affordable high-quality innovative medicines to cancer patients around the world.”

Director of Sun Yat-sen University Tumor Prevention Center and a major global researcher in the RATIONALE-305 trialXu RuihuaThe professor pointed out, “As the global chief researcher of this study, I am honored to lead and witness the exploration of tirelizumab in the field of gastric cancer. With its excellent efficacy and safety, it has helped the entire global population of advanced gastric cancer patients survive longer and set a new model for the innovative drug industry. The approval of the new indications will undoubtedly benefit more Chinese gastric cancer patients. At the same time, I also expect that the indications for the entire population will be approved one after another in the US and other markets around the world as scheduled.”

In China, 13 applications for tirelizumab (involving a total of 12 indications) have been approved by the State Drug Administration. A total of 11 items have been included in the national medical insurance drug catalogue. It is currently the PD-1 inhibitor with the highest number of approved indications included in the national medical insurance drug catalogue.

Globally, tirelizumab has been approved by the European Union, the United Kingdom, the United States, South Korea, and Switzerland, and was accepted by the US Food and Drug Administration (FDA) in February of this year for a new drug marketing license (BLA) for the treatment of patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma.

regardingRATIONALE-305(NCT03777657)

RATIONALE-305 is a randomized, double-blind, placebo-controlled, global phase 3 trial that enrolled 997 patients with locally advanced unresectable or metastatic G/GEJ adenocarcinoma. The main end point of this test is overall survival (OS). People with high PD-L1 expression and those with intentional treatment (ITT) were tested sequentially according to a pre-defined hierarchical testing strategy. The final analysis results of the ITT population were presented during the 2023 European Society of Medical Oncology (ESMO) conference in the form of an oral report on the latest breakthrough.

About Tirelizumab

Tirelizumab (Chinese product name: Baizean, English product name: TEVIMBRA) is a humanized IgG4 anti-PD-1 monoclonal antibody with high affinity and binding specificity for PD-1. The design aims to minimize binding to Fcgamma receptors in macrophages and help human immune cells recognize and kill tumor cells.

BeiGene has conducted more than 17 potential registered clinical trials of tilaserizumab. Of these, 11 phase 3 randomized trials and 4 phase 2 trials have achieved positive results. These test results show that tirelizumab, as a single agent or in combination with other drugs, has the potential to bring safe and clinically significant survival benefits and improved quality of life to hundreds of thousands of patients with various cancer types, and in many cases, patients can benefit regardless of their PD- (L) 1 expression status. Up to now, more than 900,000 patients worldwide have been treated with tirelizumab.

About BeiGene

BeiGene is a global oncology innovation company focused on developing innovative anti-tumor drugs for cancer patients around the world. Through strong independent research and development capabilities and external strategic cooperation, we continue to accelerate the development of diverse and innovative drug pipelines and product portfolios, and are committed to comprehensively improving drug accessibility and affordability for more patients around the world. We have a team of over 10,000 people across five continents and have established major offices in Beijing, China; Cambridge, MA; and Basel, Switzerland. For more information, please visit or follow the “BeiGene State” WeChat account.

Forward-looking statements

This press release contains forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995 (Private Securities Litigation Reform Act of 1995) and other federal securities laws, including BeiGene's ability to provide tirelizumab to more patients around the world; the future significance of tiralizumab in the PeGene solid tumor development program; the potential for tiralizumab to become an important treatment for G/GEJ; and PeGene State mentioned under the “About BeiGene” subheading Plans, commitments, ambitions, and goals. Actual results may differ materially from forward-looking statements due to the influence of various important factors. These factors include: BeiGene's ability to prove the efficacy and safety of its drug candidates; clinical results of drug candidates may not support further development or marketing approval; actions by the pharmacy administration may affect the initiation, schedule, and progress of clinical trials and drug marketing approval; BeiGene's ability to obtain and maintain intellectual property protection for its drugs and technologies; BeiGene's ability to obtain and maintain intellectual property protection for its drugs and technology; BeiGene's reliance on third parties for drug development, production, commercialization, and other services; Baegene Jeju's ability to obtain regulatory approval and commercialization Limited experience with chemical pharmaceutical products, and its ability to obtain further operating capital to complete drug candidate development and achieve and maintain profitability; various types of risks discussed more fully in the “Risk Factors” section of the most recent annual report on Form 10-K; and discussions on potential risks, uncertainties, and other important factors in BeiGene's post-period submission to the US Securities and Exchange Commission. All information in this press release is current only as of the date of publication of the press release, and BeiGene is not responsible for updating such information unless required by law.

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