BeiGene is established by the European Commission for the coverage of Tislelizumab as well as the control of small organisms in the European Union.

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Advanced Initial Programs with Three-Phase Clinics Investigating Tislelizumab Nutrients in Treatment-Not Previously Treated NSCLC Patients

The European Commission is in favor of the implementation of tislelizumab in the region.

BASEL, Switzerland, BEIJING & CAMBRIDGE, Mass. , USA, April 23, 2024–(BUSINESS WIRE)–BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), an oncology specialist, tells us that this is a recent topic. , dass die Europäische Kommission (EK) Tislelizumab zur Behandlung von nicht kleinzelligem Lungenkrebs (NSCLC) für tres Indikationen zugelassen hat, einschließlich als First- und Zweitlinienbehandlung.

“Tislelizumab is a reference tool for BeiGene’s portfolio in the field of falsified tumors and its prospective for biologically affected tumors: it can be used for NSCLC, at all stages of the state, as noted by Mark Lanasa, M. D. , Ph. D. , issues out. D. , Medical Director, Solid Tumors, BeiGene. Union ischen First, for women who are in the U. S. In the U. S. and the U. S. , the FDA has provided oversight of the CCHS guidelines and we have a way to paint and deliver this cutting-edge treatment for all of our patients.

Indications for tislelizumab include the following:

Dans los angeles kombination mit carboplos angelestin und input IERTEM NSCLC.

In combination with pemetrexed and platinum-based chemotherapy as curative therapy in patients with Nicht-Plattenepithel NSCLC, tumors have PD-L1 expression in ≥50% of the tumor and have an EGFR or ALK positive mutation and local N writing SCLC Leiden and for surgical studies or platinum-based radiochemotherapy in Betracht gezogen wird, or with metastatic NSCLC.

As monotherapy, a remedy for patients with local cancer or metastatic NSCLC is required for platinum-based therapy.

“Nicht kleinzelliger Lungenkrebs ist no vor eine der häufigsten and tödlichsten Krebsarten in Europa, 50% of patients diagnosed bereits ein fortgeschrittenes Stadium erreicht haben, wodurch die Behandlung erschwert wird,” said Dr. Luis Paz-Ares, Leiter der Abteilung f in his Onkologie Soy Hospital Universitario 12 de Octubre de Madrid.

These indications for NSCLC are tislelizumab under the logo called TIZVENI. The ®BeiGene plant, NSCLC indications with the secondary line indication ESCC under the TEVIMBRA® logo for combinations, were launched in the next edition of the years 2024 in the first EU countries. in the market not unusual. In the U. S. and the European Union, TEVIMBRA is intended for the control of threats of metastasis or metastases of ESCC according to the desired chemotherapy criteria and lately of the European Agency and the U. S. FDA. U. S. and the U. S. , as well as the rules for patients. que son inoperables, localmente, fortgeschrittenem o metastasiertem ESCC sowie für die Erstlinienbehandlung von Krebserkrankungen des Magens or der gastroösophagealen Verbindung geprüft.

The European Comproject is in phase 3 studies in the RATIONAL programmes, with 1,499 patients:

RATIONALE 307 (NCT03594747) is a randomized, phase 3 study of 360 patients with forged epithelial platinum plate. The studies worked well for you first: the procedure to administer tislelizumab in combination with chemotherapy aims for statistical significance and flexible progression tracking (PFS) to meet your goals and maximum safety. Advanced knowledge of Ereignisse (TEAE) is described or analyzed in the higher grades and neutrophils, neutropenia and leukopenia. The full studies can be found in the JAMA Oncology veröffentlicht.

RATIONALE 304 (NCT03663205) is a randomized Phase 3 in 334 patients with robust local studies or metastases of NSCLC nicht-plattenepithel. Die Studie erreichte ihren primären Endpunkt. Dabei führte Tislelizumab comme Erstlinienbehandlung in Combiation mit einer Chemotherapie zu aer statistically significant erung de PFS im Vergleich zur Chemotherapie (HR: 0. 65 [95% KI: 0. 47-0. 91]; P = 0. 0054) sowie zu höheren Ansprechraten und einer längeren Ansprechdauer. Written high or higher grades of TEAEs are in the context of chemotherapy and neutropenia and umfassten leukopenia. The full studies are published in the Journal of Thoracic Oncology.

RATIONALE 303 (NCT03358875) is a randomized phase 3 review of tislelizumab in the setting of docetaxel, in 805 patients with fortified studies that are not followed through small organs of the lungs (NSCLC), in the classification of patients with ‘platinum-based chemotherapy apie fortgeschritten war. The studies reached the first endpoint, tislelizumab in a two- or three-line treatment in the setting of docetaxel with statistical significance and clinical significance of treatment strategies in the target population (HR: 0. 6). 6 (95% CI 0. 56-0. 79); P<0. 0001), without interruption of PD-L1 expression. Die am häufigsten gemeldeten TEAE dritten oder höheren Grades waren Pneumonie, Anämie et Atemnot. The full studies are published in the Journal of Thoracic Oncology.

BeiGene has more than 17 prospective risk studies with Tislelizumab initiated, of which 11 randomized Phase 3 studies and 4 Phase 2 studies have been positive. In those studies, Tislelizumab has the most productive prospective, treating cancer patients in a patient with a tumor – after the decline in the prestige of PD-(L)1 – as monotherapy and also in combination with other major curative clinics within the framework of the ben and Lebensqualität zu verschaffen care program. Bisher wurde Tislelizumab is quoted to more than 900,000 patients.

About NSCLC

The Lungenkrebs is the current Krebsart and the world total of the Krebsbedingte Todesfälle. 1 In Europe, the Lungenkrebs is the dritthäufigste Krebsart, and the NSCLC has an 85-90% lead over the Gesamtheit of the Lungenkrebserkrankungen. 2 As of 20 January 20 Wird Die Zahl der Neu Diagnostizierten Lungenkrebsfälle in Europe auf 477,534 geschätzt. 3

About Tislelizumab

Tislelizumab is a humanizing monoclonal antibiotic exclusive of immunoglobulin G4 (IgG4) generated through the Zelltodprotein 1 (PD-1) protein programmed with this affinity and binding by PD-1. This is the binding to the Fc-gamma receptor (Fcγ-) in macrophages that aim to decrease the amount and, therefore, the immunity of the agents responsible for the implantation and monitoring of tumors.

Wichtige Sicherheitshinweise

The European Product Reference Standard (SmPC) for NSCLC indications for tislelizumab, as well as protection dates for NSCLC and CCHS, are through the European agency.

About BeiGene

BeiGene is a global oncology specialist, having developed and developed cutting-edge responses for cancer patients within the global organization. With a short product portfolio, we offer you the opportunity to grow our portfolio of cutting-edge therapies through our in-house functions. and operations. Our company is the solution to medicines for the largest number of real patients, who are for them. Our global team of more than 10,000 academics and scholars is present on the continent and supports abatement activities in Basel, Beijing and Cambridge (USA). You can also check out BeiGene on www. beigene. com and check out LinkedIn, X (ehemals Twitter), and Facebook.

Zukunftsgerichtete Aussagen

This press committee enthält zukunftsgerichtete aussagen im Sinne of Private Securities Litigation Reform Act von 1995 et other bundesstaatlicher Wertpapiergesetze, einschließlich aussagen über die Fähigkeit von BeiGene, seine Verpflichtung zu erfüllen, Tislelizumab more Patients auf der ganzen Wel t zur ung zu stellen, the potential of Tislelizumab, the care of patients with chronic diseases with healing clinics, which means physical care and quality of life to provide, and plans, treatments, maximum productive responses and other people from BeiGene im Abschnitt «Über BeiGene “. Die tatsächlichen Ergebnisse können aufgrund a threat is provided in the security facilities of the corporations These things deal with hygiene, fitness and defense within the task candidates, Ergebnisse clinics within the task candidates, the most competent. for the status quo or the market do not have the support of the masses der Aufsichtsbehörden, die sich auf die Einleitung, den Zeitplan und den Fortschritt der klinischen Studien und die Marktzulassung auswirken können; BeiGene standards, a business technique for other drug markets and task applicants, are established through those standards, BeiGene standards, the coverage of its own wisdom in making plans and technology. and, BeiGenes Abhängigkeit von Dritten bei der Entwicklung, The organization and marketing of pharmaceutical products and other facilities, the control of pharmaceutical products within the company, the monetary means for the industry and sale of pharmaceutical products twicklung seiner Arzneimitterlkandidaten zu erhalten et die Rentabilität Also indicated are zu erreichen und aufrechtzuerhalten, et die Risks, the “threatening things” in the last months of the BeiGene Form 10-K, as well as the prospective evaluation of threats, threats and other things in the stages of BeiGene with the Stock Exchange United States Values. Commission. All data contained in this press committee are provided at the stand in the time point of view of this press committee. BeiGene does not apply this update data, but it is not such a product.

You can check out BeiGene’s medical resources to access our news and media site.

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1 Globocan 2020. 900-fiches-mondiales. pdf (iarc. fr).

2 Europäische Gesellschaft für Medizinische Onkologie, What is non-small mobile lung cancer?https://www. esmo. org/content/download/7252/143219/file/en-non-small-mobile-lung-cancer-guide- para-pacientes. pdf.

3 Sung H et al. World Cancer Statistics 2020: GLOBOCAN estimates of global occurrence and mortality of 36 cancers in 185 países. CA Cancer J Clin. 2021; 71(3):209-49.

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Original in businesswire. com consulted: https://www. businesswire. com/news/home/20240423861748/de/

Contacts

Investor Contact: Liza Heapes 1 857-302-5663ir@beigene. com

Media Contact: Kyle Blankenship 1 667-351-5176media@beigene. com

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