January 13, 2025 Source: drugdu 44
On January 8, Yingen Bio and Avenzo Therapeutics jointly announced that the two parties have signed an exclusive license agreement.
Under the agreement, Avenzo will obtain the exclusive rights to develop, manufacture and commercialize DB-1418/AVZO-1418 worldwide (excluding Greater China). Yingen Bio will receive a down payment of US$50 million and is eligible to receive development, registration and commercialization milestone payments of up to US$1.15 billion. In addition, Yingen Bio is also eligible to receive a share of Avenzo's sales revenue in its region.
It is reported that DB-1418 is an EGFR/HER3 bispecific antibody drug conjugate (ADC) developed by Yingen Bio. It is currently undergoing a new drug clinical trial application (IND) support study and plans to enter the clinical research stage this year.
Star Biotech has made another success.
According to Yingen Bio's official information, the company is an innovative biopharmaceutical company in the clinical stage, focusing on the development of a new generation of antibody-drug conjugates (ADCs) for patients with cancer and autoimmune diseases. The company has successfully built multiple new-generation ADC technology platforms with global intellectual property rights. At present, Yingen Bio has a rich clinical ADC R&D pipeline, including bispecific ADC, new mechanism-loaded ADC and autoimmune ADC, and has conducted multiple global multicenter clinical trials in more than 17 countries, enrolling more than 1,500 patients.
At the same time, Yingen Bio has reached a number of overseas licensing cooperations with global pharmaceutical companies and top innovative pharmaceutical companies. According to statistics, Yingen Bio has reached cooperation with 4 large pharmaceutical companies or biotechs, covering 6 innovative ADC new drugs, and has received a total of US$400 million in advance payments and milestones.
DB-1418/AVZO-1418, which is authorized for overseas use, is an antibody-drug conjugate (ADC) based on topoisomerase-1 inhibitors targeting dual targets of EGFR/HER3, and is developed based on Yingen Bio's proprietary DIBAC platform. In preclinical studies, DB-1418/AVZO-1418 showed higher binding affinity to tumor cells and has demonstrated its potential efficacy in a variety of solid tumors, including tumors that are resistant to EGFR, low EGFR expression, or HER3 resistance.
The drug is currently undergoing new drug clinical trial application (IND) support research, and Yingen Bio expects to enter the clinical research stage this year.
The partner chosen by Yingen Bio this time, Avenzo Therapeutics, is a clinical-stage biotechnology company focused on developing next-generation oncology therapies for patients. Dr. Zhu Zhongyuan, founder and CEO of Yingen Bio, said, "Yingen Bio and Avenzo have a common goal of developing the next generation of tumor therapies and addressing unmet treatment areas. Based on preclinical research data, we believe that the therapeutic effect of DB-1418/AVZO-1418 has the potential to surpass other therapies."
Domestic bispecific ADCs have taken the lead.
With the rise of ADC drugs, bispecific ADCs are considered to be an important development direction for the next generation of ADCs.
Compared with monoclonal antibody ADCs, bispecific ADCs have many advantages: they can enhance cell killing toxicity and overcome drug resistance through dual targets, enhance tumor cell specificity and reduce side effects, and bispecific ADCs produce new binding and endocytosis dynamics mechanisms, which can achieve better therapeutic effects.
At present, no bispecific ADCs have been approved for marketing in the world, and not many have entered the clinical stage, and most of them are from Chinese pharmaceutical companies. The fastest progress is BL-B01D1 of Baili Tianheng and JSKN003 of Corning Jeol. At present, both new drugs have reached licensing cooperation and found joint development partners.
In December 2023, BMS reached a BD transaction with SystImmune, a subsidiary of Chinese pharmaceutical company Baili Tianheng, with a total amount of US$8.4 billion, with a down payment of US$800 million, to obtain an EGFR/HER3 dual-target ADC drug BL-B01D1. This transaction not only set a record for the down payment of license-out transactions for innovative drugs
in China , but also set a new record for the total price of single-drug transactions in the world. In September 2024, Corning Jeol reached a licensing agreement with Shijiazhuang Pharmaceutical Group to develop, sell, promise to sell and commercialize JSKN003 in mainland China for the treatment of tumor-related indications. According to the licensing agreement, Corning Jeol has the right to receive up to a total of RMB 3.08 billion in advance payments and milestone payments.
In addition to Baili Tianheng, Corning Jeol, and Yingen Bio, there are many other Chinese pharmaceutical companies that have developed bispecific ADCs. For example, Zhengda Tianqing's HER2 bispecific ADC TQB2102 has entered the Phase III clinical trial stage. Tongyi Pharmaceutical, Xuanzhu Bio, Biocytogen, Xiangyao Bio, and Sibowo Bio have all disclosed bispecific ADC pipelines, and there will be no shortage of cooperation opportunities in the future.
Conclusion
In the cutting-edge field of bispecific ADC, Chinese pharmaceutical companies have undoubtedly seized the initiative. However, it is worth noting that bispecific ADC has not yet been commercially verified, and whether it can become the next big drug track requires further consideration.
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