Zebtini has won the international guide ceiling after being nominated for the Galen Award, what did BeiGene do right?

The first edition of the National Comprehensive Cancer Network (NCCN) Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) Guidelines 2023 was recently updated

To the first line without del (17p)/TP53 mutation "Class I priority", the pressure on the first generation of BTK inhibitors, obtained the highest level of international guidelines recommended

Best-in-class, evidence-based medicine as a guide to innovation

Best-in-class, evidence-based medicine as a guide to innovation

As one of the main reference guidelines for cancer diagnosis and treatment in China, the NCCN guidelines are based on evidence-based medical evidence and driven by expert consensus, and are the internationally recognized "gold standard" for clinical practice in the oncology community

Safety has become a key factor

Safety has become a key factor

In BeiGene, there is a belief that has always been unwavering – that when doing projects, you must find differentiation and do the best

Multiple head-to-head study data support the confirmation that it surpasses first-generation BTK inhibitors across the board in terms of therapeutic efficacy and safety

In the head-to-head global Phase 3 clinical trial ALPINE study, zebutinib demonstrated a better overall response rate than ibutinib, with better safety and tolerability, demonstrating the clinical benefit of zebutinib for R/R CLL/SLL;

The results of the interim analysis of the global Phase 3 SEQUOIA trial showed that zebutinib significantly prolonged progression-free survival in patients, strongly supporting zebutinib as a more efficient and low-toxicity treatment option for CLL/SLL first-line therapy, reaffirming its strength

The authoritative guidelines of the Chinese Society of Clinical Oncology (CSCO) and the dual recommendations of the National Comprehensive Cancer Network (NCCN) have promoted zebutinib to become the gold standard

A global innovation forged by long-termism

A global innovation forged by long-termism

Zebutinib's footsteps never stop, and higher possibilities are being written

On July 26, 2022, zebutinib was included in the list

In addition to the authoritative determination of the regulatory authorities of various countries, zebutinib has also passed another narrow door

It has been ten years since the establishment of the project, and the great success of Zebutinib is by no means a stroke of genius, behind which is the long-term doctrine

It has been ten years since the establishment of the project, and the great success of Zebutinib is by no means a stroke of genius, behind which is the long-term doctrine

Faced with ibutinib, which occupied the main share of the market at that time, how did zebutinib prove itself? With extraordinary confidence and confidence, BeiGene resolutely chose CLL/SLL, the main battlefield of directly cutting into the BTK inhibitor market by "head-to-head" trials, and engaged ibutinib, which once occupied the first line of treatment class I recommendations in the NCCN guidelines, and demonstrated the potential "best-in-class" treatment effect

In order to make more patients "Living Longer with BGB-3111", zebutinib is undergoing extensive clinical trial projects

The outstanding clinical value of zebutinib based on product differentiation has been further consolidated in BeiGene's global multi-center clinical research, laying a solid foundation

The outstanding clinical value of zebutinib based on product differentiation has been further consolidated in BeiGene's global multi-center clinical research, laying a solid foundation

The commercial footprint of zebutinib has traveled to 50 countries or regions around the world

As an important therapeutic drug for the treatment of diseases such as B-cell lymphoma, inflammation and autoimmunity, the BTK inhibitor market has huge growth space
.
Frost & Sullivan's analysis report shows that with the increase in the number of patients and the approval of new indications, the market size of BTK inhibitors is expected to reach $20 billion by 2025 at a compound annual growth rate of 22.
7%, and the market size of BTK inhibitors in China is expected to reach $
2.
6 billion.

Including zebutinib, 5 BTK inhibitors have been approved worldwide, including ibutinib, akatinib, tirarutinib, obutinib, and the basic layout is in the field of
hematomas and autoimmune diseases.
The subsequent market competition will enter a white-hot stage
.
CLL/SLL indications for zebutinib are expected to be approved by the FDA in January 2023 and open up limitless imaginations based on the "best-in-class" therapeutic potential confirmed in the global Phase 3 head-to-head trial and the highest level of recommendations from current international guidelines
.

Rely on the "best-in-class" therapeutic potential confirmed in the global Phase 3 head-to-head trial and the highest level of recommendations from current international guidelines to open up unlimited imagination

Progressive, innovative pharmaceutical companies in the future

Progressive, innovative pharmaceutical companies in the future

Zebutinib is just the beginning, and there are several potential "first-of-its-kind" or "best-in-class" projects within BeiGene's product pipeline, with 10+ IND applications
expected to begin in 2024.
Starting in 2017, BeiGene began to exert efforts to first-in-class, gradually increasing the proportion of FIC projects, such as the HPK1 inhibitor BGB-15025
, which is currently in the clinical stage.
In May 2021, the clinical application for BGB-15025 capsules was officially accepted by NMPA for the treatment of solid tumors, marking the first self-developed potential FIC drug in the true sense of BeiGene entering the clinical stage
.

Compared with the "transformation to internationalization" often talked about by domestic pharmaceutical companies, internationalization has been written in the genes of BeiGene as early as possible
.
Born global, BeiGene has built a global new drug research and development system with the standards and requirements of the global market at the beginning of its establishment, and has forward-looking established a leading global layout and key internal and external capabilities
.

Born global, BeiGene has built a global new drug research and development system with the standards and requirements of the global market at the beginning of its establishment, and has forward-looking established a leading global layout and key internal and external capabilities
.

BeiGene has built a science-based commercialization team of more than 3,400 people dedicated to bringing high-quality, innovative medicines to more patients who
are expected to benefit from them.
As this update of the guidelines brings guiding significance to the clinical treatment of CLL/SLL, the two-way empowerment of product quality and commercial circulation efficiency gives us reason to expect the success of
zebutinib in the next phase.

In addition to the global commercialization team, BeiGene has independently established the largest global R&D team
in the field of oncology.
With more than 3,300 people and growing, more than 60% of the more than 100 clinical projects conducted are global, multi-center clinical trials with an independent global clinical development team that has built a large-scale, global internal independent clinical
development capability.
More than 100 planned or ongoing clinical trials have been conducted in more than 45 countries and territories, with a total enrollment of more than 16,000 participants
.

At present, BeiGene's pipeline layout has covered more than 80% of the world's cancer types, and has completed a systematic layout in the fields of hematological tumors and immuno-tumors, and will further expand to non-tumor areas, including immunology/inflammation
.
In terms of supply chain layout, BeiGene has built production bases in Suzhou, China, Guangzhou, and Hopwell, New Jersey, respectively, to meet the global commercialization and clinical trial supply needs of
drugs.

Growing into a global multinational pharmaceutical company is the dream of most innovative pharmaceutical companies, but only a very small number of innovative pharmaceutical companies can finally cross the "death canyon" between drug research and development innovation and transformation, and carry the test of commercialization and transformation.

With the complete capacity of the whole industry chain and the full coverage of multi-mechanism drugs in the field of oncology, BeiGene is driven by the heavy BIC products of source innovation, driven by the ability of large-scale, global multi-regional and multi-center clinical trials, and the international road escorted by commercial efficiency is becoming more and more mature
.

With the complete capacity of the whole industry chain and the full coverage of multi-mechanism drugs in the field of oncology, BeiGene is driven by the heavy BIC products of source innovation, driven by the ability of large-scale, global multi-regional and multi-center clinical trials, and the international road escorted by commercial efficiency is becoming more and more mature
.

The power of action is to know more and more, and the depth of knowledge is to achieve more and
more.
As BeiGene continues to deliver its clinical R&D achievements and commercialization footprint around the world, it will further lead the international market layout in the field of biotechnology and consolidate and enhance its leading position
in the industry.

How can innovative pharmaceutical companies grow into global multinational pharmaceutical companies? This is a road
of great waves and sand, nine deaths.
BeiGene may have gone out of its way
.

References[1] NCCN Guidelines Version 1.
2023 Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma.

References[1] NCCN Guidelines Version 1.
2023 Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma.