China's NMPA has approved a new indication for Hengrui Medicine's ruikang qutozhu single-antibody, SHR-A1811, a self-developed HER2 antibody-drug conjugate, for adults with HER2-positive colorectal cancer who failed treatment with oxaliplatin, fluorouracil and irinotecan. The approval, shown on the NMPA website on August 6, makes it the first approved ADC drug for colorectal cancer. The conjugate binds HER2-expressing tumour cells, is internalised, and releases its toxin after protease cleavage in lysosomes to induce cell cycle arrest and apoptosis.
China's NMPA approved Tinentinib tablets on August 4, marking the first commercialized self-developed innovative drug from Hong Kong-listed biotech Junction (Nanjing) Pharmaceutical, known as Yaojie Ankang. The drug treats adults with advanced metastatic cholangiocarcinoma who have received at least one prior systemic therapy and failed FGFR inhibitor treatment. Tinentinib is a multitarget small-molecule inhibitor of FGFR, VEGFR, JAK and Aurora pathways designed to overcome acquired resistance seen with first-generation FGFR inhibitors.
Alphamab Oncology (Kangningjieri) has licensed ex-Greater China global rights to JSKN016, a first-in-class TROP2/HER3 bispecific antibody-drug conjugate, to AI drug discovery firm Pathos AI. Pathos AI will pay a $125 million upfront fee plus milestone payments, bringing the total deal value to $2.093 billion. JSKN016 has dosed its first patient in a Phase III trial in triple-negative breast cancer.
A study published in Nature Biotechnology used protein engineering to modify the botulinum neurotoxin type X protease (BoNT/X), giving it new substrate recognition capability and inducing inflammatory death in cancer cells. Conventional pyroptosis depends on caspase-1 cleavage of gasdermin D; the engineering strategy repurposes a neuron-targeting toxin for precise tumor killing.
Why it matters: The article describes engineering a botulinum toxin to induce pyroptosis in cancer cells, showing how a neurotoxin can be repurposed as a tumor-killing tool.
A team led by Professor Yanhong Deng at the Sixth Affiliated Hospital of Sun Yat-sen University published the PICC-2 randomized controlled trial in The Lancet Oncology. In patients with dMMR/MSI-H locally advanced colorectal cancer, adding the COX-2 inhibitor celecoxib to neoadjuvant toripalimab raised the pCR rate from 69% with monotherapy to 89% in the combination group, an absolute difference of 20 percentage points, with manageable safety.
Why it matters: The article reports pCR rates for both the combination and monotherapy groups, letting readers judge the incremental benefit of a COX-2 inhibitor in neoadjuvant immunotherapy for dMMR/MSI-H colorectal cancer.
Alphamab Oncology, through its wholly owned subsidiary Jiangsu Alphamab Biopharmaceuticals, granted US clinical-stage biotech Pathos AI an exclusive licence for JSKN016, a first-in-class TROP2/HER3 bispecific antibody-drug conjugate for breast cancer, in a deal valued at 14.22 billion yuan. Alphamab will also receive warrants to subscribe for Pathos preferred shares with a total subscription price of $62.5 million. The agreement was announced on 4 August 2026.
Jiangsu Alphamab Oncology has granted Pathos AI exclusive rights to develop and commercialize JSKN016, a first-in-class TROP2/HER3 bispecific antibody-drug conjugate, outside China. The deal includes $125 million upfront and up to $2.09 billion in development, regulatory and sales milestone payments, plus tiered royalties after launch. JSKN016 was developed in-house using Alphamab's single-domain antibody and glycosite-specific conjugation platforms. Next steps are Pathos-led ex-China development and commercialization.
Alphamab Oncology has granted Pathos AI an exclusive licence to JSKN016, a first-in-class TROP2/HER3 bispecific antibody-drug conjugate, outside greater China, with a total potential deal value of up to $2.218 billion. Pathos AI, a US company focused on AI-driven oncology drug development, will pay $125 million upfront plus up to $2.093 billion in milestones and tiered royalties, and will bear all overseas clinical and commercialisation costs. Alphamab retains full rights to JSKN016 in mainland China, Hong Kong, Macau and Taiwan.
Lantheus has agreed to an $8 billion acquisition that will combine global isotope production, radiodiagnostics and targeted radiotherapy into an integrated nuclear medicine company spanning oncology, neurology and cardiovascular disease across more than 70 countries. Funding combines debt and equity financing with no earnout conditions attached. Closing requires Lantheus shareholder approval plus regulatory and antitrust reviews in multiple markets, with completion expected in the first half of 2027.
Curium and Lantheus Holdings (NASDAQ:LNTH) have signed a definitive agreement under which Lantheus will merge with a wholly owned subsidiary of Curium US Holdings LLC, in a deal worth $8 billion. Both companies develop and supply radiopharmaceuticals aimed at improving cancer diagnosis and treatment. Completion of the merger is the next step.
The US FDA has approved Novartis's Pluvicto for PSMA-positive metastatic hormone-sensitive prostate cancer (mHSPC), roughly doubling the eligible patient population. In the PSMAddition study, Pluvicto plus standard of care (ADT plus ARPI) reduced the risk of disease progression or death by 33% versus standard of care alone, with a positive overall survival trend (HR=0.80). About half of men with mHSPC progress within 20 months.