Zhangjiang Pharma Valley Weekly Update (No.1): Multiple Approvals, Clinical Advances, and Strategic Collaborations

Recently,Shanghai Institute of Materia Medica, Chinese Academy of SciencesGong Li-Kun's team collaborated with Wang Bing-Shun's team from the Clinical Medical Research Institute of Shanghai Jiao Tong University School of Medicine, in an international academic journalInternational Journal of Biological SciencesPublished an article titled“Hepatic Stellate Cells-derived IL-11 Exacerbates Liver Fibrosis via Interplaying between HSCs and Macrophages”The research paper. This paper mainly reveals the key biological function of interleukin-11 (IL-11) secreted by hepatic stellate cells (HSCs) in driving liver fibrosis. IL-11 establishes a self-amplifying vicious cycle by simultaneously acting on HSCs themselves and macrophages, thereby continuously exacerbating disease progression.

January 6,ArkBioCompound Lisdexamfetamine Dimesylate Capsules (Aizhida)^®) has been approved by the NMPA for marketing, applicable for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients aged 6 years and above.

January 8,MicroMedTecIndependently DevelopedSelf-Expanding Intracranial Aneurysm Occluder（MeshCoil®）Approved for marketing by NMPA. This is the first Class III innovative medical device approved for marketing in Shanghai in 2026.

January 2,NeuShen TherapeuticsNeuShen Therapeutics announced that its independently developed novel highly selective muscarinic acetylcholine M4 receptor positive allosteric modulator (M4 PAM) NS-136 has received FDA approval to initiate a Phase II clinical trial for the treatment of agitation symptoms in Alzheimer's disease.

January 4,Yiming AngkeAnnounced that its subsidiary, Yiming Kael's IMC-003/IMM72 (ActRIIA-Fc fusion protein) project for pulmonary arterial hypertension (PAH), has successfully completed the enrollment of all subjects in the single ascending dose (SAD) stage of the first-in-human trial.

January 4,Shoreline BiosciencesArkBio Announces Initiation of Phase I Clinical Trial for ACCG-2671 Oral Small Molecule Obesity Treatment.

January 7,HUTCHMEDAnnounced that the Phase III stage of the ESLIM-02 China study for the company's self-developed Solecupinib in the treatment of warm antibody autoimmune hemolytic anemia has achieved positive topline results.

January 8,HUTCHMEDAnnounced that its self-developed Solecupenib Acetate Tablets have been proposed for priority review. The indication is for adult patients with primary chronic immune thrombocytopenia (ITP) who have previously failed or relapsed after receiving first-line standard treatments (glucocorticoids, immunoglobulins).

January 8,Hansoh PharmaAnnounced that the company's independently developed Amelotin^®(Hansoh Pharma's Almonertinib Mesylate Tablets) Fifth Indication Approved for Marketing: In combination with pemetrexed and platinum-based chemotherapy, indicated for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations.

Recently,MicroMedTec^®YouTongEight urology products successfully passed the EU CE MDR certification. Thus, MicroMedTec^®Uroton has accumulated 11 products that have obtained EU CE certification.

January 5,Insilico MedicineA research and development collaboration worth up to $888 million has been reached with Servier. This collaboration combines Insilico Medicine's AI-driven drug discovery platform with Servier’s global expertise in oncology drug development, focusing on the discovery and development of innovative anti-cancer therapies. Under the agreement, Insilico Medicine is eligible to receive upfront and near-term R&D milestone payments of up to $32 million and will leverage its proprietary AI technology platform to identify and advance potential drug candidates that meet established R&D and scientific standards.

January 5,ShoreBioAnnounced that its subsidiary Gasherbrum Bio has reached an agreement with Roche/Genentech to non-exclusively license the patent for a small molecule GLP-1 receptor agonist (different from Aleniglipron) to the latter. Genentech will pay $100 million upfront and low single-digit royalties on CT-996 sales.

January 7,MabwellAnnounced the signing of a global strategic cooperation agreement with Sentonix, Inc. Both parties will focus on Parkinson's disease, Alzheimer's disease, and other neurodegenerative disease fields, jointly exploring the early discovery and clinical translation of next-generation innovative drugs.

Recently,Zelgen PharmaAnnounced the licensing of global rights outside Greater China for the DLL3/DLL3/CD3 tri-specific antibody ZG006 to AbbVie. The latter will pay an upfront payment of $100 million, near-term milestone payments based on clinical progress, and payments related to license options up to $60 million. If AbbVie exercises the license option, Zelgen Biopharma is also eligible to receive milestone payments of up to $1.075 billion, as well as sales royalties in the high single-digit to mid-double-digit percentages.