Multinational pharmaceutical company AbbVie has recently sued BeiGene again.
According to market news, AbbVie accuses BeiGene of hiring a senior scientist who used to work at AbbVie and stealing trade secrets to develop competitive anti-cancer therapies. The focus of the lawsuit involves two products under development, namely AbbVie's BTK degradation agent ABBV-101 and BeiGene's BGB-16673.
Affected by this news, the stock price of BeiGene (688235. SH; 06160. HK) fell significantly today. As of the close on September 12th, BeiGene closed at 144.01 yuan per share on the A-share market, down 10.61%, with a total market value of 191.848 billion yuan; The Hong Kong stock market closed at HKD 118.3 per share, down 5.44%, with a total market value of HKD 1630.12.
In response to this, BeiGene told 21st Century Business Herald reporters, "AbbVie has filed a lawsuit against our company, claiming that BeiGene misappropriated its trade secrets for the Bruton tyrosine kinase (BTK) degradation agent project, which includes the compound BGB-16673 independently discovered by BeiGene researchers through years of innovative research. BeiGene will firmly defend itself against AbbVie's allegations. BeiGene denies this accusation and will firmly defend its intellectual property rights against the lawsuit
We are currently carefully reviewing AbbVie's complaint and will respond appropriately through legal procedures. BeiGene values intellectual property rights and respects the effective intellectual property rights of others. BeiGene stated that this lawsuit will not affect our ability to serve patients or conduct operations.
Attempting to impede the progress of drug development?
For BGB-16673, BeiGene's official WeChat account shows that on August 27th, the US FDA has granted BGB-16673 fast track designation for the treatment of relapsed/refractory (R/R) chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) patients who have previously received at least two lines of treatment, including BTK inhibitors and BCL2 inhibitors.
Mehrdad Mobasher, Chief Medical Officer of BeiGene Hematology, said, "BGB-16673 is the first investigational drug on the BeiGene CDAC platform, which will consolidate our leading position in the field of hematology and complement our core hematology product Zebutinib. BGB-16673 has the potential to become an important treatment option for patients with disease progression and limited choices after using BTK inhibitors
BeiGene also expressed its views on this infringement. We believe that the lawsuit intends to impede the development process of BGB-16673, which is currently the fastest progressing BTK degradation agent in clinical development. BeiGene had already applied for a patent for BGB-16673 several years before AbbVie first applied for a BTK degradation agent patent BeiGene said.
It is reported that BeiGene has one of the largest tumor research teams in the industry, and has achieved a leading position in the field of hematological oncology research with outstanding achievements. So far, more than 300 patients from 15 countries and regions have received treatment in the BGB-16673 global clinical development project, which was launched several years earlier than the AbbVie project, according to information from clinicaltrials.gov.
BeiGene further told 21st Century Business Herald reporters that the focus on promoting the BGB-16673 development project will not be interrupted by this lawsuit. The drug has the potential to become an important treatment option for patients with disease progression and limited choices after using BTK inhibitors.
In fact, recent disputes over innovative drug patents have occurred frequently, and the patent strategy for innovative drugs has become an increasingly important issue for enterprises. For example, the new generation of "anti influenza miracle drug" Mabaloxavir has also sparked patent disputes between multinational pharmaceutical companies' original drugs and domestic first generic drug companies.
An analyst once pointed out to the reporter of the 21st Century Economic Report that "with the continuous improvement of the R&D strength of local innovative pharmaceutical enterprises, the patent dispute between multinational enterprises and local enterprises will become more common, and the failure of one party will lead to huge losses. In order to balance this interest issue, the national patent law is also constantly improving, striving to ensure the interests of import manufacturers, and at the same time, the drugs developed by local manufacturers can be effectively guaranteed."
Competitive anxiety
In fact, this is not the first "confrontation" between AbbVie and BeiGene.
As early as June 15, 2023, Pharmacyclics, a subsidiary of AbbVie, accused the BeiGene BTK inhibitor Zebutinib of infringing on the company's Imbruvica (Ibrutinib) related patent and has filed a lawsuit in the Delaware District Court in the United States. This is the first patent infringement lawsuit filed by AbbVie against Brukinsa.
Public information shows that the industrial transformation of BTK inhibitors took approximately 20 years from the discovery of BTK targets to the approval of new drugs. As an important therapeutic drug for treating diseases such as B-cell lymphoma, inflammation, and autoimmune diseases, there are currently five BTK inhibitors approved worldwide, including Johnson&Johnson's Ibrutinib, AstraZeneca's Akatinib, Ono Pharmaceuticals' Tilarutinib, BeiGene's Zebutinib, and Norinco's Obutinib, which are mainly used in the fields of hematological malignancies and autoimmune diseases.
According to AbbVie's financial report data, Ibrutinib is the earliest approved BTK inhibitor used to treat various blood disorders, autoimmune related diseases such as stem cell transplantation, post transplant immune resistance, and arthritis. In November 2013, Ibrutinib was approved by the US FDA and achieved sales of $692 million in its first year on the market. Subsequently, sales skyrocketed to $9.683 billion in 2021. But in 2022, Ibrutinib sales experienced their first decline.
The second-generation BTK inhibitor Zebutinib was developed by BeiGene and began clinical trials in 2014, and was approved by the FDA in 2019. From the current market performance of BeiGene's related products, Zebutinib is undoubtedly an outstanding product. According to the US stock financial report, in the first half of 2024, Zebutinib's global sales totaled $1.126 billion, and its semi annual performance once again exceeded the $1 billion mark.
Public information shows that currently, Zebutinib has been approved in over 70 markets worldwide and is the only BTK inhibitor to achieve superior efficacy compared to Ibrutinib in head to head trials. According to BeiGene's financial report, global sales of Zebutinib have exceeded one billion US dollars in 2023.
According to the Frost Sullivan report, as the number of patients increases and new indications are approved, it is expected that the BTK inhibitor market will reach $20 billion by 2025 with a compound annual growth rate of 22.7%, and expand to $26.1 billion by 2030 with a compound annual growth rate of 5.5%.
The BTK inhibitor market is huge and has significant growth potential, but the competition in this field is also fierce. In fact, the intense competition in the BTK inhibitor market is also considered a major reason for the first patent confrontation between AbbVie and BeiGene. As the two sides engage in another confrontation, the outcome remains to be seen.