Recent Articles in Trials & Approvals

Nanjing Leads Biolabs presented clinical data from a Phase I/II trial of LBL-024, a bispecific antibody composed of an anti- PD-L1 and an anti-4-1BB (CD137) antibody. The candidate showed efficacy as a monotherapy for patients with advanced malignant tumors, particularly extrapulmonary neuroendocrine carcinoma (EP-NEC) patients who had failed at least one line of chemotherapy. EP-NEC is a rare disease that usually occurs in the stomach, intestines and pancreas. Because the diagnosis is usually made at a late stage of the disease, the cancer has already metastasized, and the prognosis is poor. There is no approved therapy for EP-NEC. More details....

Share this with colleagues:

Yantai RemeGen reported positive data from a first-in-human China Phase I/II trial of RC88, an ADC that targets mesothelin (MSLN) and delivers a monomethyl auristatin E (MMAE) payload. MSLN, a glycosylphosphatidylinositol-anchored protein, is overexpressed in several solid tumors with limited expression in normal tissues. The trial enrolled 170 patients with ovarian, non-small cell lung and cervical cancers who had previously failed other therapies. Currently, chemotherapy is the standard of care for ovarian cancer with an overall response rate of 12%, while RC88 recorded a 42% ORR in the trial. More details....

Stock Symbols: (HK: 9995; SHA: 688331)

Share this with colleagues:  

Guangzhou’s Akeso reported that its bispecific antibody, ivonescimab, a combination of PD-1 and VEGF, posted better progression-free survival results than Merck’s Keytruda in patients with non-small cell lung cancer. It is the first time Keytruda was bested by another PD-1 candidate, according to the company. The data came from an interim analysis of ivonescimab in a China Phase III trial in NSCLC patients with positive PD-L1 expression. Specific data will be presented in an upcoming scientific meeting. In late 2022, Summit Therapeutics in-licensed US/EU/Japan rights for ivonescimab in a $5 billion deal. More details....

Stock Symbol: (HK: 9926)

Share this with colleagues:  

San Diego’s Gyre Therapeutics was approved to begin China trials of F230, a selective endothelin receptor antagonist, to treat pulmonary arterial hypertension. Gyre is a clinical-stage biotech that develops anti-fibrotic therapeutics for several chronic organ diseases. The China trial will be run by Gyre Pharmaceuticals, an indirectly controlled Gyre subsidiary located in Beijing. F230 was originally licensed from Eisai via Gyre’s indirect majority stockholder, GNI Group Ltd of Japan. More details....

Stock Symbol: (NSDQ: GYRE)

Share this with colleagues:  

Suzhou CStone Pharma 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. More details....

Stock Symbol: (HK: 2616)

Share this with colleagues: