AstraZeneca Secures Two Chinese Biotech Licensing Deals in One Month, Totaling Over $2.4 Billion

On November 20, Shanghai Jiaochen Biomedical Co., Ltd. announced that it had entered into a global exclusive licensing agreement with AstraZeneca for UA022, a small-molecule candidate drug targeting the KRAS G12D mutation in the preclinical stage.

Under the terms of the agreement, AstraZeneca will obtain an exclusive global license for the research, development, and commercialization of UA022. Shanghai Jiaochen Biomedical Co., Ltd. will be eligible to receive a $24 million upfront payment, as well as potential development and commercialization milestone payments totaling up to $395 million, plus tiered royalties on net sales.

This is the second licensing deal with a Chinese pharmaceutical company that AstraZeneca announced in November. On November 9, AstraZeneca had just reached a $2 billion licensing agreement with Chengyi Biopharma for a small-molecule GLP-1 receptor agonist.

Shanghai Jiaochen Biomedical Co., Ltd. was established in January 2020, focusing on the two major fields of autoimmune diseases and cancer. Committed to addressing unmet clinical needs, the company develops First-in-class or Best-in-class novel drugs with independent intellectual property rights and global equity. Currently, the company has more than 10 products under research and development, covering major disease areas such as oncology, autoimmune diseases, and osteoarthritis.

Shanghai Jiaochen Biomedical Co., Ltd. boasts a strong team background, with its core members hailing from multinational pharmaceutical companies and leading domestic CROs. The team possesses extensive project development experience in the fields of small-molecule drug and antibody drug R&D. Currently, it has an R&D team of over 30 professionals, more than 80% of whom hold doctoral or master’s degrees.

In just three years since its establishment, Shanghai Jiaochen Biomedical Co., Ltd. (Yousen Jianheng) has rapidly advanced multiple drug candidates into clinical development. Among these, UA007 has progressed most swiftly. UA007 is a Class 1 innovative drug independently developed by the company for the treatment of acute gouty arthritis by inhibiting the IL-1 signaling pathway. Compared with IL-1 antibody drugs already marketed or under investigation both domestically and internationally, UA007 features a short half-life, poses no risk of immunosuppression, and demonstrates a favorable safety profile, making it particularly suitable for symptomatic treatment of acute gouty arthritis attacks. In August 2022, the first subject was dosed in the Phase 2a clinical trial evaluating the safety and efficacy of UA007 in the treatment of acute gouty arthritis.

UA021 from Jiaochen Biomedical is also noteworthy. It is a potent, selective, and orally bioavailable TYK2 inhibitor. By allosterically targeting the pseudokinase (JH2) domain of TYK2, it exhibits high selectivity over other members of the JAK family. Consequently, it is expected to overcome the toxicities associated with active-site JAK inhibitors. UA021 has demonstrated in vitro and in vivo activities comparable to or superior to those of competing candidates in preclinical studies, along with an excellent safety profile in preclinical toxicity assessments. It holds the potential to achieve better in vivo target coverage and efficacy in patients. UA021 is currently being evaluated in Phase I clinical trials in Australia.

Apart from UA007 and UA021, the small-molecule candidate drug UA022, which targets the KRAS G12D mutation, is currently attracting the most attention.

UA022, the subject of this collaboration with AstraZeneca, is an effective, selective, orally administered small-molecule drug targeting the KRAS G12D mutation. KRAS mutations are highly prevalent across various cancer types, with G12D being the most common subtype, accounting for approximately 26% of all KRAS mutations. It is frequently observed in pancreatic cancer, colorectal cancer, and non-small cell lung cancer.

The KRAS family has long been recognized as one of the most frequently mutated oncogenes in cancer, and the critical role of KRAS mutations in tumorigenesis is widely acknowledged. However, mutant KRAS proteins have historically been considered “undruggable” targets. Currently, two drugs targeting the KRAS G12C mutation have received regulatory approval: sotorasib from Amgen (USA) and adagrasib from Mirati Therapeutics (USA). Nevertheless, there remains a significant unmet clinical need for therapies addressing KRAS G12D, G12V, and G13D mutations.

Currently, there are no approved KRAS G12D inhibitors; however, numerous pharmaceutical companies have entered the race to develop therapies targeting KRAS G12D. For instance, Hengrui Medicine initiated clinical studies of its KRAS G12D inhibitor in August 2022. Mirati’s KRAS G12D inhibitor has been approved for Phase I clinical trials. On May 22, 2023, Astellas submitted a clinical trial application in China for ASP3082, marking the first KRAS G12D protein degrader to enter clinical development globally.

UA022, licensed through a collaboration between Shanghai Jiaochen Biomedical Co., Ltd. and AstraZeneca, will enter the competitive landscape as the latest contender. Currently, UA022 has demonstrated potent anticancer activity, a favorable safety profile, and good oral bioavailability in preclinical models.

At the recently concluded China International Import Expo (CIIE), Wang Lei, Global Executive Vice President of AstraZeneca and President of International Business and China, stated, “This year marks the 30th anniversary of AstraZeneca’s deep-rooted presence in China. Over these three decades, China has become AstraZeneca’s second-largest global market and a key growth engine. Looking ahead, we will continue to drive the consolidation of global production capacity into China through investment, accelerate the localization of more innovative achievements, and support the global expansion of Chinese innovations.”

AstraZeneca’s investment landscape in China has become increasingly mature. In addition to establishing the AstraZeneca-CICC Industrial Fund, which provides bidirectional empowerment from R&D to commercialization for enterprises and investment partners, jointly fostering innovative development in China’s healthcare industry, AstraZeneca’s collaborations with Chinese biotech firms in 2023 were also particularly noteworthy:

• On February 23, AstraZeneca entered into a global exclusive licensing agreement with Keymed Biosciences and Lepu Biopharma for CMG901, a potential first-in-class Claudin18.2-targeting antibody-drug conjugate (ADC), with a total value of up to $1.125 billion;

• On May 12, a $600 million global exclusive licensing agreement was reached with Lixin Pharma for the preclinical-stage GPRC5D-targeted ADC drug candidate LM-305;

• On June 16, a three-year R&D collaboration was initiated with Kelan Pharmaceuticals to develop innovative drugs for hypercholesterolemia and related metabolic diseases;

• On November 9, a $2 billion licensing agreement was reached with Chengyi Biopharma for a small-molecule GLP-1 receptor agonist;

• On November 20, a global exclusive licensing agreement worth over $400 million was reached with Shanghai Jiaochen Biomedical Co., Ltd. for the UA022 project.

An increasing number of innovative Chinese pharmaceutical companies have garnered broader industry attention through their collaborations with AstraZeneca.