The US FDA has granted accelerated approval to Bristol Myers Squibb's Zenbexus (iberdomide) in combination with subcutaneous daratumumab and dexamethasone (ZDd) for adults with multiple myeloma who have received at least one prior line of therapy. Zenbexus is the first cereblon E3 ubiquitin ligase modulator (CELMoD) therapy approved by the FDA. The approval is based on results from the phase 3 EXCALIBER-RRMM trial.
Taiho Oncology and Cullinan announced that REZILIENT3, a phase 3 trial of zipalertinib combined with platinum chemotherapy, met its primary endpoint of progression-free survival with a manageable safety profile. The multicenter, randomized, open-label trial enrolled 285 previously untreated patients with EGFR exon 20 insertion-mutated locally advanced or metastatic nonsquamous NSCLC, with chemotherapy alone as the control, and results came at a planned interim analysis.
Why it matters: REZILIENT3 provides PFS data in first-line EGFR exon 20 insertion NSCLC that can be compared directly with existing options for this subtype.
A study published in Cell reports a bivalent molecular glue that bridges p300/CBP with BCL6, activating a cell death program in lymphoma cells. Using chemically induced proximity (CIP), the work targets oncogenic transcription networks that p300/CBP supports in malignant tumors by maintaining enhancer and super-enhancer activity.
Why it matters: Bridging p300/CBP with BCL6 via chemically induced proximity offers another approach to targeting enhancer-driven oncogenic transcription networks.
China's National Medical Products Administration has approved fizzeftamab for injection (brand name Jingfei), filed by I-Mab Biopharma (Hangzhou), for adult multiple myeloma patients who have received at least one prior line of therapy. The drug is to be used in combination with lenalidomide and dexamethasone, giving these patients a new treatment option.
GABA-related signatures are upregulated in TLS-positive tumors from patients who do not respond to immune checkpoint inhibitors, shown in multi-omic profiling of clear cell renal cell carcinoma and soft tissue sarcoma. GABA from tumor cells impairs B cell maturation, IgG production, HLA-DR expression, proliferation and immunoglobulin secretion in vitro. Pharmacological inhibition of GABA synthesis increased ICI response and B cell infiltration in a TLS-positive sarcoma mouse model, supporting GABA targeting to overcome ICI resistance.
China's NMPA has approved Akeso's ivonescimab injection plus chemotherapy as first-line treatment for advanced squamous non-small cell lung cancer, the drug's third approved lung cancer indication. The approval rests on the Phase 3 HARMONi-6/AK112-306 study of 532 patients, which met all primary and secondary endpoints with statistically significant PFS and OS benefit versus PD-1 antibody plus chemotherapy and a good safety profile; OS results were presented at the 2026 ASCO plenary session and published in The Lancet.
AbbVie has registered a Phase III trial (NCT07756645) on ClinicalTrials.gov comparing ABBV-1480 plus chemotherapy against pembrolizumab plus chemotherapy as first-line treatment in 940 patients with locally advanced or metastatic non-small cell lung cancer. ABBV-1480 (RC148) is a PD-1/VEGF bispecific antibody from RemeGen that AbbVie licensed in January for ex-Greater China rights with $650 million upfront and a $5.5 billion total deal value. The trial is expected to start in September 2026 and finish in December 2029, with PFS and OS as primary endpoints.
NMPA approved a new indication for Hengrui Medicine's HER2 ADC ruikang trastuzumab (Aivida) on August 6 for adults with HER2-positive colorectal cancer who failed prior oxaliplatin, fluorouracil and irinotecan treatment. It becomes China's first targeted therapy specifically for HER2-positive colorectal cancer. The pivotal study showed nearly doubled progression-free survival and an overall response rate of 40.7%.
Yaojie Ankang, a biotech founded in 2014, has received approval for its first innovative drug, a class 1 small molecule known in Chinese as a selective FGFR inhibitor. The approved indication is adults with advanced, metastatic or unresectable cholangiocarcinoma carrying FGFR2 fusion or rearrangement who have already received systemic therapy and FGFR inhibitor treatment. Industry data cited put the global cholangiocarcinoma drug market at $2 billion in 2024, projected to reach $3.2 billion by 2027.
NMPA approved Jiangsu-based Trap Therapeutics' lead product Jienta (Tinengotinib tablets), an FGFR inhibitor, on August 6. The drug is described as the first China-developed drug to address resistance after prior FGFR inhibitor treatment in cholangiocarcinoma patients. It is the company's first approved innovative drug and Nanjing's second Class 1 innovative drug approval of 2026, after Vicore Pharma's Vimpto in June.
NMPA has approved Yaojie Ankang's lead drug, its multitarget small-molecule kinase inhibitor, for adults with advanced, metastatic or unresectable cholangiocarcinoma who have received at least one prior systemic therapy and an FGFR inhibitor. This is the company's first approved innovative drug; it acts on tumor cells and the tumor microenvironment to exert antitumor effects.
China's NMPA has approved a new indication for Hengrui's HER2 antibody-drug conjugate ruikang trastuzumab... the product named in Chinese as a trastuzumab conjugate in adults with HER2-positive colorectal cancer that failed treatment with oxaliplatin, fluorouracil and irinotecan. The approval, dated August 6 under filing CXSS2600018, is the product's third approved indication in China.
A team led by Jianjun Cheng at ShanghaiTech University published a Cell paper revealing a new mechanism by which serotonin 2A receptor agonists regulate antitumor immunity in colorectal cancer. The original background notes that psychiatric symptoms such as depression and anxiety in cancer patients correlate with prognosis, and whether psychedelics have direct antitumor activity independent of central nervous system effects remains unclear. The study used the classic 5-HT2A receptor agonist lysergic acid diethylamide (LSD) as its entry point.
Why it matters: The mechanism of 5-HT2A receptor agonists in colorectal cancer antitumor immunity offers a reference for psychiatric drugs crossing into tumor immunology.
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.
