VCBeat Pharma Weekly | Novo Nordisk's long-acting growth hormone approved in China; Jacobio Pharma inks global deal with AstraZeneca
Clinical Progress
AstraZeneca's Benralizumab Injection approved for new indication in China
On December 22, AstraZeneca's Benralizumab Injection (brand name: Fasenra®, generic name: Benralizumab Injection) received approval from the China National Medical Products Administration (NMPA) for a new indication, for the treatment of adult eosinophilic granulomatosis with polyangiitis (EGPA).
In addition, Trastuzumab Deruxtecan for Injection (brand name: Enhertu®, generic name: Trastuzumab Deruxtecan for Injection), co-developed and commercialized by AstraZeneca and Daiichi Sankyo, recently received approval from the China NMPA. It is indicated as a monotherapy for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultra-low (IHC 0 with membrane staining) breast cancer who have progressed on one or more prior lines of endocrine-based therapy in the metastatic setting.
Oral Semaglutide Tablet approved in the US, becoming the first oral GLP-1 product for weight management
On December 22, Novo Nordisk announced that the U.S. Food and Drug Administration (FDA) has approved the oral semaglutide tablet (once-daily oral semaglutide 25 mg) for reducing excess body weight and sustaining long-term weight reduction, as well as lowering the risk of major adverse cardiovascular events. This tablet represents the first approved oral glucagon-like peptide-1 (GLP-1) receptor agonist treatment regimen for weight management.
Novo Nordisk's long-acting growth hormone Sogroya approved in China
On December 22, the China National Medical Products Administration (NMPA) officially approved the marketing application of Novo Nordisk's long-acting growth hormone (LAGH) injection, Sogroya. It is indicated for the treatment of children aged 2.5 years and older with growth failure due to inadequate secretion of endogenous growth hormone. This approval marks the drug as the first internationally developed long-acting growth hormone to serve pediatric patients in China.
Johnson & Johnson terminates a bispecific antibody clinical study
On December 26, Johnson & Johnson announced on its official website the termination of the Phase IIb DUPLEX-AD trial evaluating JNJ-5939 in patients with moderate-to-severe atopic dermatitis. Johnson & Johnson stated that the study was discontinued early because "results from a planned interim analysis did not meet the high efficacy bar set for advancing the atopic dermatitis clinical development program."
Clinical Progress
InventisBio's D-0502 combined with Alphamab Oncology's ADC JSKN016 approved for IND in China for advanced breast cancer
Recently, a combination therapy comprising InventisBio's self-developed innovative drug D-0502 (an oral selective estrogen receptor degrader [SERD]) and Alphamab Oncology's self-developed JSKN016 (a bispecific antibody-drug conjugate [ADC] targeting TROP2/HER3) received clinical trial approval from the China National Medical Products Administration (NMPA). The intended indication is for patients with locally advanced or metastatic HR-positive, HER2-negative (HR+/HER2-) breast cancer. This approval marks the official initiation of the first clinical exploration of D-0502 in combination with an ADC-based therapy, aiming to provide a new potential treatment option for patients with HR+/HER2- advanced breast cancer who have progressed on endocrine-based combination therapy.
Hengrui Pharma's innovative drug SHR-A1904 for gastric cancer included in breakthrough therapy designation list
Recently, the injectable SHR-A1904, developed by Hengrui Pharma and its subsidiary Shanghai Hengrui Pharma, was included in the Breakthrough Therapy Designation list by the Center for Drug Evaluation (CDE) of the NMPA. The designation is for its use as a monotherapy in patients with CLDN18.2-positive locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma who have received at least one prior line of systemic therapy. A Phase I study of SHR-A1904 monotherapy in gastric cancer patients who failed at least one line of standard treatment demonstrated favorable safety and antitumor activity. The results were published in Nature Medicine in 2025, indicating its potential to offer more treatment options for patients with advanced CLDN18.2-positive gastric cancer.
Simcere Zaiming's bispecific antibody-drug conjugate SIM0610 approved for clinical trial
On December 23, Simcere Zaiming announced that its self-developed bispecific antibody-drug conjugate (BsADC) candidate, SIM0610, received approval from the NMPA to enter clinical trials. The planned study will involve patients with locally advanced/metastatic solid tumors. SIM0610 is a BsADC that simultaneously targets the epidermal growth factor receptor (EGFR) and mesenchymal-epithelial transition factor (cMET). It is composed of a humanized anti-EGFR/cMET bispecific antibody conjugated via a cleavable, hydrophilic linker to a topoisomerase I inhibitor (TOP1i). Its mechanism of action involves the bispecific antibody binding to EGFR and/or cMET on the surface of tumor cells, internalization, followed by the release of TOP1i, leading to DNA damage and tumor cell apoptosis.
Zai Lab Announces FDA approval of first-in-class drug Xanomeline Trospium Chloride in China for schizophrenia treatment
On December 23, Zai Lab announced that the China NMPA has approved the New Drug Application for Xanomeline trospium chloride capsules (brand name: COBENFY®) for the treatment of schizophrenia in adults. Xanomeline trospium chloride capsules represent the first schizophrenia therapy with a novel mechanism of action approved in over 70 years, marking a fundamental breakthrough in schizophrenia treatment. Unlike the mechanism of traditional antipsychotic drugs targeting dopamine, xanomeline trospium chloride capsules work by selectively acting on muscarinic acetylcholine M1 and M4 receptors in the brain, influencing core disease pathways.
Innocare Pharma's novel TYK2 inhibitor for cutaneous lupus erythematosus receives CDE approval for Phase II clinical trial
On December 23, Innocare Pharma announced that its self-developed novel TYK2 inhibitor, ICP-488, for the treatment of cutaneous lupus erythematosus (CLE), received approval from the Center for Drug Evaluation (CDE) of the NMPA to conduct a Phase II clinical trial. ICP-488 is an oral, highly selective TYK2 allosteric inhibitor. It works by specifically binding to the TYK2 JH2 domain, blocking the signal transduction of inflammatory cytokines such as IL-23, IL-12, and type I interferons, thereby inhibiting the pathological processes of autoimmune and inflammatory diseases.
Allist Pharmaceuticals' Furmonertinib Mesilate Tablets for first-line treatment of EGFR PACC-mutant NSCLC proposed for inclusion in breakthrough therapy designation list
On December 25, the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) published a notice on its official website. The third-generation EGFR TKI, Furmonertinib Mesilate Tablets (brand name: Aifusha®), independently developed by Allist Pharmaceuticals, was included in the proposed list for Breakthrough Therapy Designation. The intended indication is 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) PACC mutations.
Innovent's Ipilimumab N01 Injection approved for marketing by the National Medical Products Administration
On December 25, Innovent announced that its Ipilimumab N01 Injection (a cytotoxic T-lymphocyte-associated protein 4 [CTLA-4] monoclonal antibody, R&D code: IBI310) has received marketing approval from the China National Medical Products Administration (NMPA). It is approved for use in combination with Sintilimab as neoadjuvant therapy for patients with resectable Stage IIB-III microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) colon cancer.
Akeso's Penpulimab Therapy gains its 5th approved indication in China
On December 26, Akeso announced on its official website that a new indication for its self-developed differentiated PD-1 monoclonal antibody, Penpulimab Injection, in combination with Anlotinib for the first-line treatment of advanced hepatocellular carcinoma (HCC) has been formally approved by the China NMPA. This approval provides an effective and innovative "immunotherapy + targeted therapy" first-line standard treatment option for China's large population of liver cancer patients.
Transaction Trends
Jacobio Pharma and AstraZeneca enter global exclusive license agreement for Pan-KRAS inhibitor JAB-23E73
On December 21, Jacobio Pharma announced that it has entered into a cooperation agreement with AstraZeneca regarding its self-developed pan-KRAS inhibitor, JAB-23E73. According to the agreement, AstraZeneca will obtain exclusive rights to develop and commercialize the product in markets outside China. Within the Chinese market, Jacobio and AstraZeneca will co-develop and co-commercialize the product.
Under the terms of the agreement, Jacobio will receive an upfront payment of $100 million and is eligible for additional development and commercial milestone payments of up to $1.915 billion, as well as tiered royalties on net sales achieved in markets outside China. AstraZeneca will be responsible for all clinical development, regulatory submissions, and commercialization activities for JAB-23E73 in markets outside China.
Simcere Zaiming and Ipsen of France enter exclusive license agreement for ADC candidate SIM0613
On December 22, Simcere Zaiming announced that it has entered into an exclusive out-licensing agreement with Ipsen of France for the global rights (excluding Greater China) to SIM0613, an antibody-drug conjugate (ADC) candidate with best-in-class potential. SIM0613 targets the LRRC15 protein and demonstrates high penetration efficiency across multiple solid tumors, offering potential treatment for certain solid tumors with urgent clinical needs.