On November 20th, AstraZeneca announced that it has reached a global exclusive licensing agreement with Usynova for the pre-clinical stage small molecule candidate drug UA022 targeting KRASG12D mutation.
Usynova is an emerging biotech company focusing on the two major areas of oncology and autoimmune diseases. UA022 is an orally administered drug developed by Usynova that selectively targets KRAS G12D mutation. It has strong anti-tumor activity and good safety profile.
Under the terms of the agreement, AstraZeneca will receive global exclusive licensing rights for the research, development, and commercialization of UA022. Usynova will be eligible to receive an upfront payment of $24 million and potential development and commercialization milestone payments of up to $395 million.
This marks the fifth collaboration between AstraZeneca and Chinese biotech companies this year. In fact, apart from AstraZeneca, numerous multinational pharmaceutical companies have been actively initiating collaborations with local pharmaceutical companies. As the second-largest pharmaceutical market in the world, China is attracting more and more overseas pharmaceutical companies to establish their presence.
AstraZeneca collaborates with Chinese pharmaceutical companies five times to target early-stage innovative drug assets
This year, AstraZeneca has frequently cooperated with Chinese pharmaceutical companies and has been very serious about exploring opportunities in China. On November 9th of this year, AstraZeneca announced a licensing agreement worth over 2 billion US dollars with Eccogene for the oral small molecule GLP-1 receptor agonist ECC5004. Eccogene was established in April 2018 and is an innovative drug research and development company focused on metabolism and immune diseases. ECC5004 is a once-daily oral GLP-1 receptor agonist (GLP-1RA) used for the treatment of obesity, type 2 diabetes, and other cardiovascular and metabolic diseases.
On February 23rd, AstraZeneca, Keymed Biosciences, and Lepu Biopharma jointly announced a global exclusive licensing agreement for CMG901. CMG901 is a potential first-in-class ADC targeting Claudin18.2. It is owned by KYM Biosciences, a joint venture between Keymed Biosciences, and Lepu Biopharma. According to the agreement, KYM will receive a prepayment of 63 million US dollars, potential additional milestone payments of over 1.1 billion US dollars related to research, development, and sales, as well as a low double-digit tiered royalty fee; AstraZeneca will obtain exclusive global license for CMG901 research, development, registration, production, and commercialization.
On May 12th, AstraZeneca and Lanova Medicines reached a global exclusive licensing agreement for the preclinical GPRC5D-targeting ADC LM-305. Under the terms of the agreement, AstraZeneca will obtain exclusive global license for the research, development, and commercialization of LM-305; Lanova Medicines will be eligible to receive near-term payments totaling 55 million US dollars, including an upfront payment, as well as potential development and commercial milestone payments of up to 545 million US dollars.
On June 16th, AstraZeneca and Cholesgen reached a 3-year research and development cooperation agreement for the development of innovative drugs for hypercholesterolemia and related metabolic diseases. Under the terms of the agreement, Cholesgen receives an upfront payment to advance the drug to the clinical stage; AstraZeneca will then have the option to further develop the target drug. Cholesgen was established in 2021 and is dedicated to developing first-in-class innovative drugs, focusing on truly novel disease targets, and conducting innovative pharmaceutical research for metabolic diseases and tumors.
In addition to cooperating with Chinese pharmaceutical companies, AstraZeneca has also established a research center in Hong Kong focused on key areas such as cell and gene therapy (CGT) drug development. More clinical trials will be conducted in Hong Kong in the future, and the center is expected to be operational by the end of 2024.
At this year's Import Expo, AstraZeneca also reached global strategic cooperation agreements with BIOKANGTAI and Amoydx, among other Chinese pharmaceutical companies.
BioNTech betting on Chinese ADC
Since the beginning of this year, AstraZeneca and BioNTech have been the most frequent buyers in China. Unlike AstraZeneca, BioNTech mainly purchases top Chinese ADC projects.
On March 20th of this year, BioNtech announced a cooperation agreement with OncoC4, introducing the latter's new generation CTLA-4 antibody ONC-392. Through a unique mechanism, CTLA-4 circulates inside and outside the cell instead of degrading CTLA-4 molecules, thereby reducing immunotherapy related toxicity caused by CTLA-4 depletion and enhancing its therapeutic effectiveness. According to the agreement, BioNtech will pay an advance payment of $200 million to OncoC4, as well as a milestone amount and a double-digit sales share.
On April 3rd, BioNTech reached a cooperation agreement with Duality Bio to introduce the global rights of the latter's two ADC new drugs outside of Greater China. BioNtech will pay a prepayment of $170 million, a milestone amount exceeding $1.5 billion, and a certain percentage of sales share.
In August, BioNTech and Duality Bio extended the cooperation agreement to jointly promote the development, production and commercialization of the third candidate ADC product DB-1305 worldwide (excluding Chinese Mainland, Hong Kong Special Administrative Region and Macao Special Administrative Region of China). Duality Bio is an innovative biopharmaceutical company in the clinical stage, focusing on developing next-generation ADC treatment drugs for cancer and autoimmune disease patients.
DB-1305 is a third-generation Trop2 ADC molecule constructed based on the proprietary DITAC platform of Duality Bio. It exhibits strong anti-tumor activity in preclinical tumor models and strong clinical efficacy in solid tumors such as non-small cell lung cancer. We are currently conducting phase I/II clinical trials for solid tumors.
On July 20th, BioNTech announced a strategic research collaboration, project introduction selection, and global licensing agreement with Biotheus Biotechnology (referred to as " Biotheus "). According to the terms of the agreement, BioNTech will obtain global exclusive selection rights for a preclinical research phase bispecific antibody and a clinical research phase monoclonal antibody used by the latter for the treatment of malignant tumors. In addition, Pumis will exclusively authorize multiple preclinical nanoantibody projects under study to BioNTech and provide targeted nanoantibody development services according to their needs.
Takeda, Pfizer, and BMS "Tap into Opportunities in China"
On October 17th of this year, members of Takeda Pharmaceutical's Global Management Committee visited China and announced a major collaboration with Belief BioMed. Takeda China will receive commercial operation licenses for Belief BioMed's investigational product BBM-H901 in mainland China, Hong Kong, and Macau. BBM-H901 is the first Chineseally approved gene therapy drug for hemophilia B that targets adenovirus-associated virus (AAV) and allows hemophilia patients to maintain clotting factor levels at clinically curative levels for an extended period of time. It also reduces the frequency of injections and avoids the risk of infection associated with blood products. Takeda has strong technological reserves and deep patient resources in the field of hemophilia.
In January of this year, Takeda Pharmaceutical signed a licensing agreement with HWL, with a total value of up to $1.13 billion, to gain rights for developing, commercializing, and manufacturing HWL 's colorectal cancer drug fruquintinib outside of mainland China, Hong Kong special administration region, and Macau special administration region of China. This collaboration signifies that Takeda's partnership with local companies is not limited to the Chinese market and aims to promote Chinese innovation on the global stage.
This year, Pfizer also made adjustments to its operations in China. The vaccine business unit established divisions in North China, South China, and a marketing platform, and appointed experienced leaders to take charge of the vaccine business unit. This move indicates Pfizer's desire to make contributions in the Chinese vaccine market.
Furthermore, Bristol Myers Squibb (BMS), which has been deeply rooted in the Chinese market for over 40 years, possesses a deeper understanding and awareness of China, the world's second-largest pharmaceutical market. In 2020, BMS launched the "China 2030 Strategy," making a long-term commitment to China's healthcare and innovation. Currently, BMS and local pharmaceutical companies have initiated confidential negotiations and discussions.
In recent years, China has continuously introduced new policies to support innovation and development, such as accelerating drug approvals, strengthening patent protection, and facilitating innovative access. Encouraged by these policies, the quality of innovation in China has been constantly improving. For many multinational pharmaceutical companies, the Chinese market is an important engine for performance growth.
Against this backdrop, multinational pharmaceutical companies have been continuously adjusting their strategies and actively engaging in various initiatives, whether it be adjusting their market layout or collaborating with local pharmaceutical companies.
References
1、 https://www.prnasia.com/story/414004-1.shtml.
2、 Dasari NA, Lonardi S, et al. LBA25 - FRESCO-2: A global phase III multiregional clinical trial (MRCT) evaluating the efficacy and safety of fruquintinib in patients with refractory metastatic colorectal cancer. Ann Oncol. 2022 Sep;33(suppl_7): S808-S869. 10.1016/annonc/annonc1089.
About the Author:
Xiaobin holds a Master's degree in Pharmacy and currently work as a public health control staff. Navigating through the intricate and complex data each day and feeling a sense of insignificance of herself. While being happy to witness the golden time of the development of Chinese bio-pharmaceutical industry. Hope to learn and improve together with everyone.
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