Innovent's PD-1 Bispecific Antibody Receives FDA Fast Track Designation; CSPC Launches Clinical Trial for Its Eighth ADC

Feb 17, 2025 19:28 CST Updated 19:28

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Pfizer's Pan-KRAS Inhibitor Cancer Drug Approved for Clinical Trials in China

On February 17, the official website of the Center for Drug Evaluation (CDE) under the China National Medical Products Administration showed that Pfizer's Class 1 new drug, the Pan-KRAS inhibitor PF-07934040 tablets, received clinical approval in China for the first time. The indication is for advanced solid tumors carrying KRAS mutations.

Overseas, Pfizer is conducting a Phase I clinical trial (NCT06447662) to evaluate the efficacy and safety of PF-07934040 as a monotherapy or in combination with other targeted drugs for the treatment of advanced solid tumors (non-small cell lung cancer, colorectal cancer, pancreatic cancer) with KRAS gene mutations. The study plans to enroll 330 participants, and the primary endpoint is expected to be completed by July 2027.

Currently, there are 38 Pan-KRAS inhibitors under development globally (only counting active statuses), of which 9 have entered clinical stages.

In China, Pfizer's recently approved PF-07934040 is the fourth Pan-KRAS inhibitor to be approved for clinical use. The other three are JAB-23E73 from Jacobio, YL-17231 from Yingli Pharmaceutical, and BGB-53038 from BeiGene.

Innovent Bio's PD-1 Bispecific Antibody Receives FDA Fast Track Designation Again

On February 17, Innovent Bio announced that its PD-1/IL-2α-bias bispecific antibody fusion protein IBI363 had been granted Fast Track Designation (FTD) by the U.S. FDA. The proposed indication is for locally advanced or metastatic squamous non-small cell lung cancer that has progressed after treatment with anti-PD-(L)1 immune checkpoint inhibitors and platinum-based chemotherapy.

IBI363 is a globally pioneering PD-1/IL-2 bispecific fusion protein independently developed by Innovent Bio, possessing both the function of blocking the PD-1/PD-L1 pathway and activating the IL-2 pathway.

On September 4, 2024, IBI363 was granted Fast Track designation by the U.S. FDA for the proposed indication of locally advanced or metastatic melanoma (excluding uveal melanoma) that has progressed following at least one prior line of systemic treatment containing a PD-1/L1 checkpoint inhibitor.

Innovent Bio is currently conducting Phase 1/2 clinical trials of IBI363 in China, the United States, and other regions simultaneously.

Hansoh Pharma's ADC New Drug Proposed for Inclusion in Breakthrough Therapy Designation, Targeting Osteosarcoma

On February 17, the CDE website announced that the injectable HS-20093, submitted by Hansoh Pharma, is proposed to be included in the breakthrough therapy category for the treatment of osteosarcoma patients who have progressed after at least two lines of treatment. HS-20093 (GSK'227) is a novel B7-H3-targeted antibody-drug conjugate (ADC). Its indication for later-line treatment of recurrent or refractory osteosarcoma was just granted Breakthrough Therapy Designation (BTD) by the U.S. FDA in January this year. This is also the second time HS-20093 has been proposed by the CDE to be included in the breakthrough therapy category after the small cell lung cancer indication, this time targeting osteosarcoma.

HS-20093, composed of a fully human anti-B7-H3 monoclonal antibody covalently linked to a topoisomerase inhibitor (TOPOi) payload, is currently undergoing multiple Phase 1, Phase 2, and Phase 3 clinical trials in China for the treatment of lung cancer, sarcoma, head and neck cancer, and other solid tumors. In December 2023, Hansoh Pharma announced the granting of an exclusive global license (excluding mainland China, Hong Kong, Macao, and Taiwan) to GlaxoSmithKline (GSK) for the development, manufacturing, and commercialization of HS-20093.

In January 2025, GSK announced that GSK'227 (HS-20093) had been granted Breakthrough Therapy Designation by the FDA.

Baili Tianheng Initiates Phase III Clinical Trial for First-Line NSCLC with EGFR Mutation

On February 17, Baili Tianhe registered a Phase III clinical trial on the "Drug Clinical Trial Registration and Information Disclosure Platform" website for BL-B01D1 + Osimertinib versus Osimertinib monotherapy as first-line treatment for EGFR-mutated locally advanced or metastatic non-small cell lung cancer.

BL-B01D1 is the world's first EGFR/HER3 bispecific antibody-drug conjugate (ADC), with multiple Phase III clinical trials ongoing. Among these, three clinical trials focusing on lung cancer are underway, including monotherapy as second-line treatment for EGFR wild-type NSCLC, monotherapy as second-line treatment for EGFR mutant NSCLC, and monotherapy as second-line treatment for SCLC. The newly initiated Phase III clinical trial now advances into first-line treatment for EGFR mutant NSCLC, in combination with osimertinib, aiming to redefine the clinical standard for first-line therapy.

CSPC Initiates Clinical Trials for Eighth ADC Drug

On February 16, CSPC Pharmaceutical Group registered a Phase I clinical trial (CTR20250511) for its ROR1 ADC drug SYS6005 in patients with various advanced malignant tumors on the CDE Drug Clinical Trial Registration and Information Disclosure Platform. This marks the eighth ADC drug from CSPC to enter clinical trials.

In the exclusion criteria for patient enrollment, SYS6005 excludes patients participating in other studies involving ROR1-targeted therapies or those previously treated with ADCs containing an MMAE payload, indicating that it is an ROR1 ADC drug with an MMAE payload. The proposed clinical dosing regimen is Q3W.

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