Shilipharma Licenses Oral GLP-1 Agonist SYH2086 Globally; Hengrunda’s CAR-T Therapy Renikio Orelansel Approved in China

Amino Observation - Original Production by the Innovative Drug Team

Author | Huang Kai

/ 01 /

Market Express

1) CSPC's Small Molecule GLP-1 Licensed to Madrigal

On July 30, CSPC announced that it would license the global rights (excluding China) of SYH2086, a small molecule GLP-1 receptor agonist, to Madrigal Pharmaceuticals. The latter will pay $120 million upfront, up to $1.955 billion in milestone payments, and double-digit percentage royalties on sales.

2) Zean An Biopharmaceuticals and Eli Lilly Reach Strategic Cooperation

On July 29, Zeanon Biopharma announced a significant strategic collaboration with Eli Lilly to develop novel "myeloid cell engager drugs" targeting specific pathways for the treatment of autoimmune diseases with substantial unmet medical needs.

/ 02 /

Pharmaceutical News

1) StarMab BioMed's SM2275 Injection Receives Clinical Approval

On July 30, according to the CDE website, StarMab BioMed's SM2275 injection received clinical approval and is planned to be studied for the treatment of advanced solid tumors.

2) Alphamab Oncology's HER2 Bispecific Antibody Drug Conjugate Granted FDA Orphan Drug Designation

On July 29, Alphamab Oncology announced that JSKN003, a HER2 bispecific antibody-drug conjugate (ADC), has been granted Orphan Drug Designation by the U.S. FDA for the treatment of gastric cancer and gastroesophageal junction cancer (GC/GEJ).

3) Another domestically produced CAR-T therapy approved for marketing in China

On July 30, according to the NMPA website, Hengrui Dason's Reni Kiohlun Injection was approved for marketing in China. It is used to treat adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma not otherwise specified, diffuse large B-cell lymphoma transformed from follicular lymphoma, high-grade B-cell lymphoma with MYC and BCL2 rearrangements, and high-grade B-cell lymphoma not otherwise specified.

4) Johnson & JohnsonThird-generation EGFR InhibitorLanreotide Approved in China

On July 30, according to the NMPA website, Johnson & Johnson's third-generation EGFR inhibitor, Lazertinib, was approved in China in combination with the EGFR/c-Met bispecific antibody, Amivantamab, for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose epidermal growth factor receptor (EGFR) has exon 19 deletions or exon 21 L858R substitution mutations.

/ 03 /

Overseas Pharmaceutical News

1) Novo Nordisk Officially Announces New CEO

On July 29, Novo Nordisk announced that Maziar Mike Doustdar will assume the role of President and Chief Executive Officer of the company starting August 7, 2025. He will succeed Lars Fruergaard Jørgensen, who will step down on the same day. Additionally, other senior management changes effective August 7 were disclosed.

2) Head-to-head Ibrutinib, Lilly's Non-covalent BTK Inhibitor Phase III Success

On July 29, Eli Lilly announced positive topline results from the Phase III BRUIN CLL-314 study. The trial compared the efficacy of the non-covalent (reversible) BTK inhibitor pirtobrutinib (Jaypirca) with the covalent BTK inhibitor Imbruvica (ibrutinib) in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL). The results showed that the study met its primary endpoint, with pirtobrutinib demonstrating superior ORR (p<0.05). PFS was not yet mature in this analysis, but a trend favoring pirtobrutinib's efficacy has already emerged. No detrimental effect on overall survival (OS) was observed.

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