According to media statistics, in the first half of 2024 alone, at least 32 innovative pharmaceutical companies in China successfully completed BD projects, achieving cross-border expansion and involving transaction amounts exceeding 20 billion US dollars, with a significant increase in quantity compared to previous years.

And this trend continues into the second half of the year, with domestic innovative pharmaceutical companies such as Ruige Pharmaceutical, Jiahe Biotechnology, Tongrun Biotechnology, and Anmai Biotechnology all having significant BD transactions.

Recently, a domestic innovative pharmaceutical company that has only been established for eight years and currently has only a few pipelines under research sold one of its products, BD, for a sky high price.

GlaxoSmithKline (GSK) has officially announced that it has reached an acquisition agreement with Chinese innovative pharmaceutical company Chimagin Biosciences for the three specific antibody CMG1A46.

Accordingly, GSK will make a prepayment of $300 million to Enmu Biotechnology to acquire all global rights to CMG1A46 (excluding Greater China). In addition, Enmu Biotechnology will also be eligible to receive a total of $550 million in CMG1A46 payments based on successful development and commercial milestones. According to the terms, the potential value of the transaction can reach up to 850 million US dollars, approximately 6.06 billion yuan.

The protagonist of this transaction, Enmu Biotechnology, is headquartered in Chengdu and has raised hundreds of millions of yuan since its establishment. It has now received a down payment of over 2 billion yuan. And what GlaxoSmithKline is interested in is the innovative drug CMG1A46 under Enmu Biotech, which has great potential for the treatment of systemic lupus erythematosus.

Enmu Biotech: Sold 6 billion yuan worth of drugs
Enmu Biotechnology is a cutting-edge Chinese biotechnology company in the global clinical research and development stage, located in Chengdu, China. The company was founded in 2016 and focuses on the research and development of First in Class new drugs. Its goal is to become an innovative antibody drug research and development company with global competitiveness.

CEO Zhou Zhenhao previously worked at the Shanghai R&D centers of Hutchison Whampoa Pharmaceuticals and Hengrui Pharmaceuticals. Since its establishment, Enmu Biotechnology has received an angel round financing of 10 million yuan in December 2016. The investor is Chengdu Gaotou Venture Capital Co., Ltd., which has a state-owned background and currently holds 9.0179% of Enmu Biotechnology's shares.

Enmu Biotechnology has developed multiple independent intellectual property multifunctional antibody engineering platforms in the fields of dual antibody and triple antibody, and constructed multiple pipelines for malignant hematological tumors, malignant solid tumors, and autoimmune diseases.

CMG1A46 is a T cell-mediated antibody independently developed by Enmu Biotechnology that targets CD3, CD19, and CD20 simultaneously. It can effectively clear B cells and is used to treat multiple drug-resistant and recurrent B cell hematological tumors. In December 2021, Enmu Biotechnology announced that it had received an SMP (Study May Procedure) letter from the FDA. The clinical trial application of CMG1A46 for the treatment of refractory and recurrent B-cell malignancies was officially approved by the FDA. In October 2022, the first subject administration of CMG1A46 in the Phase I clinical trial was completed in the United States.

In China, in December 2021, the clinical trial application of CMG1A46 was approved by the National Medical Products Administration, and it is also the world's first CD3/CD19/CD20 triple antibody product approved for clinical use. In November 2022, Borui Biotechnology and Enmu Biotechnology reached a strategic cooperation agreement, and Borui Biotechnology obtained the preclinical development, clinical registration, development, production, and commercialization rights of Enmu Biotechnology's three specific antibody BR115 (CMG6A19) in China. It is reported that CMG1A46 is currently undergoing phase I clinical trials for leukemia and lymphoma in China.
With the acquisition of CMG1A46, GSK plans to conduct Phase I clinical trials for systemic lupus erythematosus in the first quarter of 2025.

Buyer GSK: Heavy warehouse lupus erythematosus
The buyer GSK, one of the world's largest pharmaceutical companies with a market value of over 530 billion yuan, is currently "scanning drugs" in China.

Last year, it signed an agreement with Shanghai Hansen and obtained overseas licenses for two new drugs, with a total value of over 22.7 billion yuan.

GSK plans to develop and commercialize CMG1A46, with a focus on systemic lupus erythematosus (SLE), lupus nephritis (LN), and potential extension to other B-cell driven autoimmune diseases.

GSK can be said to have established a presence in the field of SLE treatment and enriched its pipeline by introducing projects from external sources. However, in recent years, GSK has encountered failures in acquiring and introducing many projects in the field of autoimmune diseases, resulting in unsatisfactory outcomes.

In October 2022, GSK announced the failure of its GM-CSF monoclonal antibody otilimab in the Phase III ContRAst-3 study for moderate to severe rheumatoid arthritis (RA), which did not meet the primary endpoint, and decided not to submit a marketing application. This result undoubtedly has a certain impact on GSK's research and development pipeline in the field of autoimmune diseases.

The rise of Belimumab in the self-administered drug market has clearly shown GSK a glimmer of hope in the segmented field. As a humanized monoclonal antibody targeting BLyS, belimumab was first approved by the FDA in March 2011 and entered the domestic market in July 2019. From global sales exceeding $600 million in 2018, it has gradually grown into a "heavyweight bomb" with global sales exceeding $1 billion, with annual sales growth exceeding 20%, bringing substantial profits to GSK.

The research and commercialization success of Belimumab have also raised expectations for the future market potential of CMG1A46 in the industry.

The company stated that through the development of new drugs for systemic lupus erythematosus and lupus nephritis, it has gained a deeper understanding of the potential driving factors of B-cell driven diseases.

The CMG1A46 included in this package is a T cell-mediated antibody that can simultaneously target CD3, CD19, and CD20, effectively clearing B cells.

As early as 2021, it was officially approved by the FDA and is currently undergoing phase I clinical trials for leukemia and lymphoma in China. Next, GSK plans to focus on developing indications for autoimmune diseases represented by systemic lupus erythematosus and lupus nephritis.

Layout of domestic and international free race tracks
Currently, self immunotherapy is the second largest market area after cancer, with a global self immunotherapy drug market size of approximately 132.3 billion US dollars in 2022. According to Frost&Sullivan's prediction, by 2030, the global self immunotherapy drug market size is expected to reach 176 billion US dollars, with a compound annual growth rate of 3.6% from 2022 to 2030.
Looking at the world, not only GSK, but also companies such as Novartis and Sanofi are outstanding in the field of autoimmune diseases.

China lags far behind foreign countries in the field of self exemption, but in recent years, the development of self exemption drugs in China has been rapid

Dizhe Pharmaceutical's JAK inhibitor, golixitinib, is a highly selective JAK1 inhibitor and the world's first and only novel mechanism therapy for peripheral T-cell lymphoma (PTCL) that acts on the JAK/STAT pathway. It was approved by the National Medical Products Administration for initial release in China in June 2024.

Kangnuo Biological's IL-4R alpha antibody drug, Sipuximab, is the first domestically developed and approved IL-4R alpha antibody drug for the treatment of moderate to severe atopic dermatitis in adults. Its drug marketing authorization application for the treatment of chronic sinusitis with nasal polyps and seasonal allergic rhinitis has been accepted by the National Medical Products Administration in September 2024.

In August of this year, Hengrui Pharmaceutical's Funacizumab was approved for marketing, used to treat adult patients with moderate to severe plaque psoriasis who are suitable for systemic therapy or phototherapy. It has become one of the first domestically developed recombinant anti-IL-17A humanized monoclonal antibodies approved, breaking the long-term monopoly of similar imported drugs and providing new treatment options for psoriasis patients. In August of this year, Zhixiang Jintai's domestically produced first all human anti-IL-17A monoclonal antibody, Siliquid monoclonal antibody, was approved for market launch.

Source: https://pharm.jgvogel.cn/c1459198.shtml