Evgenii Kovalev
Deals and Financings
Jiangsu Hengrui Medicine out-licensed global rights for its portfolio of three proprietary GLP-1 candidates to a US startup, Hercules, in a deal worth up to $6 billion. Hengrui will receive $110 million upfront, up to $200 million in milestones, and as much as $5.725 billion in sales milestones, plus royalties. Hengrui will own a 19.9% equity stake in Hercules as part of the deal. At the same time, Hercules, a partnership between Bain, Atlas, RTW and Lyra Capital, raised $400 million from four investors to get the company going.
Shanghai Degron Therapeutics will use its molecular glue-based targeted protein degradation drug discovery platform to identify multiple targets in oncology, neuroscience, and inflammation for Japan’s Takeda (TAK, see story). The Chinese company will receive an upfront payment and is eligible to receive potential milestone payments that could total $1.2 billion. Degron will apply its GlueXplorer platform to identify molecular glue degraders for therapeutic targets selected by Takeda. Upon reaching a specified stage of advancement, the projects will be sent to Takeda for further development and commercialization. Degron will also receive royalty payments on sales, and Takeda will make an investment of unspecified size in Degron.
AstraZeneca (AZN) announced it will build a $1.5 billion manufacturing facility in Singapore for antibody drug conjugates (‘ADCs’) to produce products for its global ADC portfolio (see story). The company has six ADCs in clinical trials and “many more” in earlier development. The new plant will be AstraZeneca’s first end-to-end ADC production site, including all steps of the process at a commercial scale: antibody production, synthesis of chemotherapy drug and linker, conjugation of drug-linker to the antibody, and filling the ADC substance. The company expects the facility will be completed in 2029.
Nona Biosciences signed a $604 million license agreement with AstraZeneca to develop preclinical monoclonal antibodies that will be used to create targeted therapies for oncology indications (see story). A global company, Nona offers early development services ranging from target validation and antibody discovery through preclinical research. AstraZeneca will make a $19 million upfront and a $10 million near-term payment, plus $575 million in potential milestones. It is also eligible for option payments on other programs. Nona is a subsidiary of Harbour BioMed, a Boston-Rotterdam-Shanghai company based on its Harbour Mice® antibody technology platform.
Beijing’s BeiGene (BGNE) announced an agreement to develop and distribute two of its marketed products in India with Glenmark Pharma of Mumbai. Glenmark will be responsible for approval and commercialization of Tislelizumab and Zanubrutinib in India. Tislelizumab is BeiGene’s anti-PD-1 monoclonal antibody approved to treat esophageal squamous cell carcinoma that is also in trials for other cancers. Zanubrutinib is a BTK inhibitor approved to treat hematological malignancies. Financial details of the agreement were not disclosed.
Company News
During an Investors’ Day, AstraZeneca’s CEO Pascal Soriot pointed towards China as an important contributor for its plans to increase revenue by 75% to $80 billion in 2030. He said innovation in China has “exploded,” and continued with praise for the country’s expertise in cell therapies: “Cell therapy in China has a very specific aspect to it, which is in the early phase of clinical development you can move much faster than anywhere else in the world.” He continued, “We have the ability to leverage that specificity, which is mostly regulatory-driven, but also the way people operate, that will help us save time and be much faster.”
Trials and Approvals
Suzhou Innovent Biologics (OTCPK:IVBIY) said its NDA for IBI311, a recombinant anti-insulin-like growth factor 1 receptor (IGF-1R) antibody, was accepted for review in China to treat Thyroid Eye Disease (‘TED’). Innovent is the first company to file an NDA in China for an anti-IGF-1R antibody aimed at TED, an autoimmune disease that causes progressive inflammation and damage to tissues around the eyes. IBI311 is a biological drug with a novel mechanism of action. Innovent expects the candidate will be approved as a first-line therapy for TED, which does not have an effective therapy currently.
Yantai’s RemeGen (OTCPK:REGMF) announced that two China Phase III trials for Telitacicept (RC18) have completed enrollment, one for IgA nephropathy and the other for primary Sjögren’s syndrome (‘pSS’). Telitacicept is a proprietary novel fusion protein aimed at treating autoimmune diseases. It targets two cell-signaling molecules critical for B-lymphocyte development: B-lymphocyte stimulator (‘BLyS’) and a proliferation-inducing ligand (APRIL) that reduces B-cell mediated autoimmune responses implicated in several autoimmune diseases. Telitacicept was granted China approval for systemic lupus erythematosus in 2023.
Suzhou CStone Pharma (OTCPK:CSPHF) released positive data from its global first-in-human Phase 1a/1b study of a ROR1 candidate in patients with advanced solid tumors and lymphomas. CStone says CS5001 is a key asset in its Pipeline 2.0. The novel ROR1-targeted ADC is designed with a unique pyrrolobenzodiazepine (‘PBD’) prodrug. CStone believes the combination of the PBD prodrug and its linker minimizes the toxicity of traditional PBD payloads. In a dose ascending trial, CS5001 has completed the first eight dose levels (7 to 125 μg/kg) without reaching the maximum tolerated dose.
Shanghai Tyligand Bioscience has dosed the first patient in a US Phase I/II trial of a small molecule candidate that targets KRAS G12D mutant solid tumors. The candidate, TSN1611, is a highly selective and orally bioavailable small molecule that targets the KRAS G12D mutation, engaging both the ON-state (GTP-bound) and OFF-state (GDP-bound) of KRAS G12D. TSN1611 has demonstrated in vivo antitumor activity with a durable response across multiple animal models, along with potential to penetrate the brain. Tyligand is approved to start similar China trials.
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