Novartis Strikes $5.7B Molecular Glue Deal; Roche to Acquire Liver Drug Developer; Innovent, Hutchmed Report Clinical Advances | Arterial Weekly Pharma Roundup

Li Jiaying Authors: Interns Chen Chuan, Zheng Ao, He Duo

New Drug LaunchExhibition

BeOne Medicines’ Zanubrutinib Capsules Initiate Phase IV Clinical Trial

On September 17, data from the Drug Clinical Trial Registration and Information Publicity Platform indicated the initiation of a Phase 4, single-arm, open-label, multicenter study by BeOne Medicines to evaluate the efficacy and safety of zanubrutinib in Chinese patients with previously untreated Waldenström’s macroglobulinemia. The primary endpoint of this trial is the proportion of patients achieving complete response (CR) or very good partial response (VGPR) at approximately 33 months; secondary endpoints include the investigator-assessed major response rate (MRR), duration of major response (DOMR), and progression-free survival (PFS) at approximately 33 months.

Innovent Bio’s Partner Ollin Announces Clinical Progress of Ophthalmic Bispecific Antibody IBI324

On September 18, Innovent Bio announced that its partner Ollin had disclosed clinical progress for IBI324. IBI324 (OLN324) is a bispecific antibody targeting vascular endothelial growth factor (VEGF) and angiopoietin-2 (Ang2), currently in Phase Ib clinical development for the treatment of wet age-related macular degeneration and diabetic macular edema. As one of Ollin’s core pipeline assets, OLN324 demonstrates the potential to become a “best-in-class” disease-control therapy, building upon the established core efficacy of anti-VEGF treatments.

Akeso’s CD47 Monoclonal Antibody Receives FDA Orphan Drug Designation

On September 16, Akeso announced on its official website that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to leflalimab (AK117), a next-generation humanized IgG4 monoclonal antibody against CD47 independently developed by the company, for the indication of acute myeloid leukemia. Leflalimab is the first CD47 monoclonal antibody globally to enter registrational Phase III clinical trials for solid tumors.

Hengrui's Lipid-Lowering Product, Icosapent Ethyl Soft Capsules, Approved for Market Launch

Recently, Chengdu Shengdi Pharmaceutical Co., Ltd., a subsidiary of Hengrui Medicine, received the Drug Registration Certificate approved and issued by the National Medical Products Administration (NMPA), approving the market launch of its icosapent ethyl soft capsules. The indicated use is: as an adjunct to dietary control, this product is used to reduce triglyceride (TG) levels in adult patients with severe hypertriglyceridemia (≥500 mg/dL).

Hengrui Medicine and its subsidiary, Fujian Shengdi Pharmaceutical Co., Ltd., have received the "Notice of Approval for Drug Clinical Trials" issued by the National Medical Products Administration (NMPA), approving clinical trials of HRS-4729 injection, a Class 1 innovative drug independently developed by Hengrui, in patients with metabolic dysfunction-associated steatotic liver disease (MASLD)/metabolic dysfunction-associated steatohepatitis (MASH). Currently, no similar products have been approved for marketing either domestically or internationally.

HUTCHMED Announces Two Innovative Anti-Cancer Drugs at the 2025 CSCO Annual Meeting

At the recently held 2025 Annual Meeting of the Chinese Society of Clinical Oncology (CSCO), HUTCHMED presented the latest clinical research data on surufatinib and katatinib across multiple solid tumor indications. The studies on surufatinib covered neuroendocrine tumors, pancreatic cancer, biliary tract cancer, soft tissue sarcoma, and triple-negative breast cancer. Data showed that its combination with transarterial embolization for liver metastases from neuroendocrine tumors achieved an objective response rate (ORR) of 44.0%, significantly superior to monotherapy. In patients with advanced pancreatic cancer accompanied by liver metastases, the combination with the NASCA regimen increased the ORR to 52.2%.

In the neoadjuvant treatment of locally advanced rectal cancer, cadonilimab combined with immunotherapy and radiotherapy achieved a pathological complete response (pCR) rate of 28.6%. As first-line therapy for metastatic colorectal cancer, it demonstrated an objective response rate (ORR) of 81.4% and a median progression-free survival (PFS) of 17.84 months. In advanced esophageal squamous cell carcinoma and refractory non-clear cell renal cell carcinoma, the combination regimens achieved ORRs of 61.5% and 48.6%, respectively, with excellent disease control rates (DCR).

Kelun Pharmaceutical Adds Two New Indications for Bupivacaine Liposome Injectable Suspension

Recently, Kelun Pharmaceutical announced that its bupivacaine liposome injection has been approved by the National Medical Products Administration (NMPA) for two new indications: popliteal sciatic nerve block in adults and adductor canal block in adults, providing a novel solution for postoperative analgesia in lower limb orthopedic surgeries. Utilizing multivesicular liposome technology, bupivacaine liposome delivers sustained analgesia for up to 72 hours with a single dose. Two Phase III clinical trials confirmed that, compared with bupivacaine hydrochloride, the new indications significantly reduce cumulative pain scores and opioid consumption within 96 hours postoperatively, effectively minimizing related adverse effects.

Market Dynamics

WuXi Biologics’ Three Manufacturing Facilities Receive GMP Certification from Turkish Medicines and Medical Devices Agency

On September 17, WuXi Biologics announced that its Drug Substance Manufacturing Facility 1 (MFG1), Drug Substance Manufacturing Facility 2 (MFG2), and Drug Product Manufacturing Facility 5 (DP5) in Wuxi have received Good Manufacturing Practice (GMP) certification from the Turkish Medicines and Medical Devices Agency (TITCK).

Guideline Recommendations

Zai Lab’s Innovative Mechanism Drug KarXT Recommended in “Chinese Guidelines for the Prevention and Treatment of Schizophrenia (2025 Edition)”

Recently, the “Chinese Guidelines for the Prevention and Treatment of Schizophrenia (2025 Edition)” was officially released, marking its first update in a decade. Notably, KarXT (xanomeline and trospium chloride), the world’s first M1/M4 muscarinic acetylcholine receptor agonist, has been included in the guidelines for the first time, representing the first instance of this drug being incorporated into a national-level guideline globally.

The updated guidelines clearly state that KarXT, an antipsychotic drug with a novel mechanism of action, differs pharmacologically from existing agents by exerting its effects through activation of central nervous system M1 and M4 receptors. Studies have demonstrated that the drug is effective against positive, negative, and cognitive symptoms, and lacks dopamine receptor blocking activity. In terms of safety, common adverse reactions to KarXT are transient gastrointestinal symptoms, while it rarely causes typical side effects associated with conventional antipsychotics, such as weight gain and extrapyramidal symptoms.

Everest Medicines’ Nefecon® Receives First-Line Recommendation in KDIGO International Guidelines

Recently, the “2025 KDIGO Clinical Practice Guideline for the Management of IgA Nephropathy and IgA Vasculitis” was officially released. Everest Medicines’ Tarpeyo® (budesonide delayed-release capsules) is explicitly recommended in the guideline as a first-line disease-modifying therapy for all patients with IgA nephropathy at risk of progressive renal function decline. This marks another endorsement by an authoritative international guideline for the drug, following its previous recommendation in Chinese guidelines.

TransactionTrends

Novartis and Monte Rosa Therapeutics Secures $5.7 Billion Partnership

On September 15, Novartis and Monte Rosa Therapeutics, a star company in the field of molecular glues, announced a licensing agreement valued at up to $5.7 billion to develop novel degraders for the treatment of immune-mediated diseases. Monte Rosa is a publicly traded company dedicated to developing highly selective molecular glue degraders (MGDs) for the treatment of serious conditions in oncology, autoimmune diseases, and inflammatory disorders. Its proprietary QuEEN platform leverages artificial intelligence to discover and develop new molecular glue degraders, which Novartis will further advance through clinical development and commercialization. This marks Novartis’s second collaboration with Monte Rosa within less than a year. Under the terms of the agreement, Monte Rosa will receive an upfront payment of $120 million, as well as potential additional milestone payments and royalties.

Roche to Acquire Liver Drug Developer for $3.5 Billion

On September 18, Roche announced plans to acquire the biotechnology company 89bio at a valuation of up to $3.5 billion. The target company’s lead drug, pegozafermin, is a first-in-class FGF21 analog designed for the treatment of liver and cardiometabolic diseases, particularly metabolic dysfunction-associated steatohepatitis (MASH). Through this acquisition, Roche will integrate 89bio’s Phase III MASH therapeutic candidate into its own R&D pipeline, further strengthening its product portfolio in the cardiovascular, kidney, and metabolic diseases (CVRM) sector.

New Drug Developments

Pfizer Releases Global Analysis Data on Myocarditis Related to COVID-19 Vaccine

On September 15, Pfizer released global analytical data on myocarditis associated with its COVID-19 vaccine. The results indicated that the mRNA vaccine Comirnaty, jointly developed by Pfizer and BioNTech, demonstrated extremely high efficacy against SARS-CoV-2 infection in early clinical trials; myocarditis is a known risk following vaccination with Comirnaty; the risk of myocarditis was highest among young males within 14 days after receiving the second dose of the primary mRNA vaccine series, while the incidence of myocarditis following booster vaccination was lower than that observed after the second dose of the primary series.

Eli Lilly’s Oral GLP-1 RA Orforglipron Demonstrates Clinically Meaningful Weight Loss and Cardiometabolic Improvements

On September 16, Eli Lilly announced the detailed results of the Phase 3 clinical trial ATTAIN-1. This study evaluated the safety and efficacy of the investigational oral GLP-1 receptor agonist orforglipron in adults with obesity or overweight with at least one weight-related comorbidity but without diabetes. At week 72, all three dose groups of orforglipron (6 mg, 12 mg, and 36 mg) met the primary endpoint, achieving significant weight loss compared with the placebo group. Furthermore, all three doses demonstrated clinically meaningful improvements over placebo across multiple key secondary endpoints, including proportions of patients achieving weight reductions of ≥10%, ≥15%, and ≥20%, as well as reductions in waist circumference.¹ These findings were presented at the 2025 European Association for the Study of Diabetes (EASD) Annual Meeting and simultaneously published in The New England Journal of Medicine.

Lilly’s Oral GLP-1 RA Orforglipron Outperforms Oral Semaglutide in Head-to-Head Study

On September 17, Eli Lilly announced positive topline results from the ACHIEVE-3 study, an open-label, randomized Phase 3 clinical trial that evaluated the safety and efficacy of orforglipron versus oral semaglutide (administered per approved labeling) in 1,698 adult participants with type 2 diabetes who had inadequate glycemic control despite metformin therapy. The 52-week study compared orforglipron (12 mg and 36 mg) with oral semaglutide (7 mg and 14 mg) across four active treatment groups in terms of glycemic control and weight reduction. At 52 weeks, all orforglipron dose groups met the primary endpoint and all key secondary endpoints, demonstrating superior improvements in glycated hemoglobin (A1C) and body weight compared with oral semaglutide.

Bayer’s Breakthrough Low-Dose MRI Contrast Agent Gadoquatrane Has Its Marketing Application Accepted in China

Bayer Announces NMPA Acceptance of Marketing Application for Novel MRI Contrast Agent GadoquatraneRecently, Bayer announced that the National Medical Products Administration (NMPA) of China has accepted its marketing application for the novel MRI contrast agent gadoquatrane. With a high relaxivity of 11.8 L/mol/s (at 1.5T), this contrast agent enables a 60% reduction in gadolinium dosage, requiring only 0.04 mmol Gd/kg body weight. It is currently the macrocyclic gadolinium-based contrast agent under application with the highest relaxivity and the lowest dosage. Gadoquatrane is indicated for the detection of lesions in the central nervous system and throughout the body in adults and children of all ages, including neonates. The global Phase III QUANTI study, which included data from Chinese patients, demonstrated favorable efficacy and safety across a broad range of indications.