Beijing Innocare Pharma Tech Co. Ltd. has received IND approval from China’s National Medical Products Administration (NMPA) for ICP-B208, an antibody-drug conjugate targeting CDH17, which is highly expressed in gastrointestinal cancers, including colorectal, gastric and biliary tract cancers and pancreatic ductal adenocarcinoma.

Simcere Zaiming Pharmaceutical Co. Ltd.’s SIM-0613 for injection has received clinical trial approval from China’s National Medical Products Administration (NMPA), enabling initiation of a clinical trial for advanced solid tumors.

Laguna Biotherapeutics Inc. has obtained IND clearance from the FDA for its cancer immunotherapeutic LGNA-100 (QUAIL-100). The planned first-in-human phase I study will evaluate LGNA-100 in pediatric and young adult participants with high-risk acute leukemias and myelodysplastic syndromes following αβ-depleted hematopoietic stem cell transplantation (HSCT) to prevent leukemic relapse.

Taiho Oncology Inc., Taiho Pharmaceutical Co. Ltd. and Araris Biotech AG have announced completion by the FDA of the IND review period for ARC-02, enabling initiation of a phase I trial by Taiho Oncology.

Naturecell Co. Ltd.’s U.S. subsidiary, Naturecell America, has received IND clearance from the FDA for Astrostem-AU, an autologous adipose-derived mesenchymal stem cell therapy for adults with autism spectrum disorder (ASD).

CSPC Pharmaceutical Group Ltd.’s SYS-6051 has gained clinical trial clearance from China’s National Medical Products Administration (NMPA) for advanced solid tumors. SYS-6051 is a human tissue factor-targeted antibody-drug conjugate that binds to tissue factor expressed on the surface of tumor cells.

Mabwell (Shanghai) Bioscience Co. Ltd.’s has announced IND acceptance by China’s National Medical Products Administration (NMPA) for the company’s LILRB4/CD3 T-cell engager bispecific antibody 6MW5311. The drug candidate is being developed for hematologic malignancies, specifically acute myeloid leukemia (AML), chronic myelomonocytic leukemia and multiple myeloma.

The U.S. FDA’s latest draft guidance on gene therapies focuses on nonclinical studies using next-generation sequencing-based methods and bioinformatics to evaluate safety risks associated with off-target editing and loss of genome integrity in human gene-edited products.

Mabwell (Shanghai) Bioscience Co. Ltd. has announced that SST-001 (18F-FD4), an α-synuclein-targeted PET tracer developed by Mabwell’s incubated company Synusight Biotech, has received clinical trial clearance from China’s National Medical Products Administration (NMPA). The planned phase I trial will enroll healthy volunteers, patients with multiple system atrophy (MSA), and patients with Parkinson’s disease.

Glyconex Inc. has received approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for the initiation of a first-in-human phase I trial of GNX-1021, the company’s lead antibody-drug conjugate (ADC) candidate, in patients with advanced gastrointestinal (GI) cancers.