BeiGene Announces Three Major Milestones for PD-1 Inhibitor Tislelizumab: EU Approval, FDA Filing Progress, and Regained Global Rights

On September 19, BeiGene (688235) announced: the company's PD-1 productTislelizumab Injection (Brand name: BeiGene)InApproved in Europe、Positive Progress in U.S. Registration, and from NovartisRegainBeiGene Global Rights.

The company's mid-year report for 2023 shows:In the first half of the year, the sales of Baizean in China totaled 1.836 billion yuan, compared with 1.251 billion yuan in the same period last year, a year-on-year increase of 47%.The financial report revealed,The increase in market penetration and market share of BeiGene's BRUKINSA is mainly attributed to the new patient demand driven by the inclusion of new indications in the medical insurance, the further improvement in the efficiency of the sales team, and the increase in the number of hospitals adopting the drug. Currently, BRUKINSA has been approved for eleven indications in China, nine of which have been included in the National Medical Insurance Catalog.

Three Major Events Regarding PD-1: Specific Details Are as Follows:

（1）Status of obtaining EU Commission marketing approval。European UnionThe committee has approved the company's core product, BeiGene's Tislelizumab Injection, as a monotherapy for the treatment of adult patients with unresectable, locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) who have previously received platinum-based chemotherapy.

(2) The acceptance by the U.S. FDA for the marketing authorization application for first-line advanced ESCC patients.

The U.S. FDA has accepted BeiGene's Biologics License Application (BLA) for tislelizumab as a first-line treatment for patients with unresectable locally advanced, recurrent, or metastatic ESCC.

（3）Regain Global Rights to BeiGene.

HundredBeiGene Terminates Collaboration and License Agreement with Novartis Signed in January 2021. BeiGene Regains Full Global Rights to Tislelizumab Without Royalty Payments. Additionally, Novartis Will Provide Transition Services and Support to Ensure the Smooth Progress of Key Aspects in the Development and Commercialization Plan for Tislelizumab.The company stated that this termination would not affect the $650 million cash upfront payment that BeiGene Switzerland had already received from Novartis., nor will it have a significant adverse impact on the company's financial condition and business operations.

Since its establishment in 2010, BeiGene has become a fully integrated global company with operations in the United States, China, Europe, and Australia.and other countries and regions have more than10,000 Employees. As of the first half of this year, the company has R&D personnel3486People, an increase of 457 compared to the same period last year;Average Salary of R&D Personnel in the First Half of the Year Reached 4.23 Million Yuan, a Year-on-Year Increase of 7.6%。

BeiGene Achieved in the First Half of 2023RevenueRMB 7.251 billion, a year-on-year increase of 72.23%, mainly due to the sales growth of self-developed products and licensed products in the first half of the year.Non-recurring Net ProfitA loss of 5.502 billion yuan,R&D ExpensesExpenditure of 5.882 billion yuan, a year-on-year increase of 17.28%,Selling ExpensesSpending reached 3.407 billion yuan, a year-on-year increase of 20.86%, mainly due to the rise in costs associated with global business expansion and increased commercial promotion efforts.

The chart below outlines the company's solid tumor R&D pipeline as of August 27, 2023:

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