Hansoh Pharma Initiates Phase III Clinical Trial of GLP-1R/GIPR Dual Agonist HS-20094

PharmCube Data presents the latest developments in new drug R&D from last week (October 28 ~ November 3), including updates on new drug R&D progress, significant drug transactions, and more, all in one quick read.

Source: Pharma Intelligence Enterprise Edition - Global Drug Analysis System Database, official websites of various enterprises

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Hansoh Pharma:
HS-20094 Injection

On October 31, according to the Drug Clinical Trial Registration and Information Disclosure Platform, Hansoh Pharma's Class 1 new drug HS-20094 injection has initiated a Phase III clinical study. Public data shows that HS-20094 is a GLP-1R/GIPR dual agonist.

Source of the image: Drug Clinical Trial Registration and Information Disclosure Platform

HS-20094, independently developed by Hansoh Pharma, selectively activates the GIP receptor and GLP-1 receptor to promote insulin secretion, delay gastric emptying, and suppress appetite to reduce food intake, thereby generating biological effects such as blood sugar control, weight loss, and metabolic improvement. Its administration method is once weekly via subcutaneous injection.

In September 2024, the Phase II clinical research data of HS-20094 was presented as an oral report at the 60th Annual Meeting of the European Association for the Study of Diabetes (EASD). The study results showed that in patients with type 2 diabetes (T2DM), HS-20094 demonstrated a favorable overall safety profile and significant effects in reducing glycated hemoglobin (HbA1c), fasting blood glucose, and body weight.

This study registered by Hansoh Pharma on the Drug Clinical Trial Registration and Information Disclosure Platform is a multi-center, randomized, double-blind, placebo-controlled Phase III clinical trial evaluating the efficacy and safety of HS-20094 injection in overweight or obese subjects.

To date, only Eli Lilly's tirzepatide, a GLP-1R/GIPR agonist, has been approved for marketing globally. HS-20094 is one of the GLP-1R/GIPR dual agonists with faster clinical progress, and is expected to bring new options for weight loss and glucose-lowering treatment.

Progress in the Development of Other New Drugs

1.MSD/Moderna Launch New Clinical Trial for "V940" Combination Therapy

On October 28, Merck and Moderna announced the launch of a combination therapy using the neoantigen mRNA vaccine V940 (mRNA-4157) and a PD-1 antibody for NSCLC patients who did not achieve pCR after PD-1 + chemotherapy neoadjuvant treatment. mRNA-4157 is a personalized cancer vaccine that targets specific mutations in patients and encodes up to 34 neoantigens. This vaccine can activate T cells specific to tumor neoantigens, thereby killing tumor cells.

2. Yimiao Zhongshu/Sunshine Nuohua "ZM001 Injection" Approved for Clinical Trials

On October 28, Yimiao Zhuhai announced that the ZM001 injection, a next-generation CAR-T drug for the treatment of Systemic Lupus Erythematosus (SLE) co-developed with Sunshine Nova, received the clinical trial approval notice from the NMPA. This approval marks a significant breakthrough for Yimiao Zhuhai in the field of CAR-T cell therapy for autoimmune diseases. It is their first clinical approval for a CAR-T cell drug to treat autoimmune diseases and their seventh CAR-T cell drug clinical approval.

3. Xintong Pharmaceutical "Praefovir Mesylate Tablets" Approved for Marketing

On October 28, according to the NMPA official website, the Class 1 innovative drug Pradefovir Mesylate Tablets (brand name: Xinsumu), submitted by Xi'an Glen Neotong Pharmaceutical Co., Ltd., was approved for marketing. This medicine is suitable for treating adult chronic hepatitis B. It is reported that Pradefovir Mesylate Tablets are nucleotide-based liver-targeting prodrugs that introduce an aryl phosphonate cyclic diester structure based on the Adefovir framework, which can significantly inhibit the replication of the hepatitis B virus.

4. SSGJ "Recombinant Anti-BDCA2 Humanized Monoclonal Antibody Injection" Approved for Clinical Trials

On October 29, according to the CDE official website, two clinical trial implied licenses were granted for 3SBio's Class 1 new drug "Recombinant Anti-BDCA2 Humanized Monoclonal Antibody Injection," indicated for Systemic Lupus Erythematosus (SLE) and Cutaneous Lupus Erythematosus (CLE). Public information shows that 3SBio’s Anti-BDCA2 Humanized Monoclonal Antibody Injection (R&D code "626") has already received an IND approval in the United States and is being developed for the treatment of SLE and CLE indications.

5. Lilly Announces Results of "Donanemab" Study

On October 29, Eli Lilly announced positive results from the Phase IIIb TRAILBLAZER-ALZ 6 study. The study showed that a modified dosing regimen of donanemab reduced the risk of effusion-type amyloid-related imaging abnormalities (ARIA-E) and was as effective as the standard dosing regimen in reducing amyloid plaques and P-tau217. Eli Lilly is discussing the results of this study with global regulatory agencies to update the labeling for donanemab.

6. AstraZeneca "AZD5492" Approved for Clinical Trials

On October 29, according to the CDE official website, AstraZeneca's Class 1 new drug AZD5492 received clinical trial implied permission for the indication of relapsed or refractory B-cell malignancies. Public data indicates that this drug is a CD20×TCR×CD8 trispecific antibody. At the 2024 EHA Annual Meeting held in June this year, AstraZeneca announced preclinical study data of AZD5492 for B-cell non-Hodgkin lymphoma. Relevant studies show that AZD5492 has the potential to significantly improve the treatment outcomes for B-cell lymphoma.

7.Zai Lab Announces Phase 3 Bridging Study Data for "KarXT"

On October 29, Zai Lab announced the primary data from the Phase 3 bridging study of KarXT for the treatment of schizophrenia in China. This registrational bridging study met its primary endpoint, demonstrating a statistically significant 9.2-point reduction from baseline in the Positive and Negative Syndrome Scale (PANSS) total score at week five compared to placebo. Zai Lab also stated that it is actively advancing and plans to submit a New Drug Application (NDA) for KarXT to the NMPA in early 2025.

8. Novartis "Scemblix" New Indication Receives FDA Accelerated Approval

On October 29, Novartis announced that Scemblix (Asciminib) received FDA accelerated approval for the treatment of newly diagnosed chronic-phase Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML-CP) in adult patients. This FDA approval is based on the positive results from the Phase III ASC4FIRST study. ASC4FIRST is the first and currently the only Phase III clinical trial to conduct a head-to-head comparison with approved standard treatments (i.e., first- and second-generation TKIs).

9. Lilly's "Pirtobrutinib Tablets" Approved for Marketing in China

On October 29, according to the NMPA official website, Eli Lilly's BTK inhibitor Pirtobrutinib Tablets received approval for its marketing application. Based on the priority review information previously disclosed by the CDE, the approved indication for Pirtobrutinib Tablets is: as monotherapy for adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have previously received BTK inhibitor treatment.

10. Dongcheng Pharmaceuticals "177Lu-LNC1004 Injection" Receives FDA Fast Track Designation

On October 30, Dongcheng Pharmaceuticals announced that 177Lu-LNC1004 Injection, a product under research by its subsidiary Lan Nac Cheng, had been granted Fast Track designation by the U.S. FDA. This product is intended for the treatment of patients with metastatic iodine-131 refractory differentiated thyroid cancer who have received one or more tyrosine kinase inhibitors. According to publicly available information, 177Lu-LNC1004 Injection is a radiopharmaceutical for internal use targeting fibroblast activation protein (FAP). It achieves precise tumor treatment by delivering the radioactive isotope lutetium-177 specifically to solid tumors with positive FAP expression.

11. Huanma Bio "HM2002 Injection" Submits for Clinical Trial

On October 30, according to the CDE official website, the clinical trial application for HM2002 injection submitted by Huanma Biotech was accepted. Based on publicly available information from Huanma Biotech, this is an innovative circular RNA (circRNA) drug developed by the company and also a novel gene therapy drug specifically designed for "therapeutic angiogenesis." Preclinical study results showed that, in animal models of myocardial infarction, HM2002 injection promoted blood vessel regeneration, reduced infarct size and fibrotic areas, and significantly improved cardiac function, offering promising new options for the treatment of ischemic heart disease.

12. Johnson & Johnson's "Amivantamab Subcutaneous Injection Formulation" New Indication Approved for Clinical Trials in China

On October 31, according to the CDE official website, Johnson & Johnson's application for the subcutaneous injection formulation of Amivantamab was approved for clinical trials for two new indications. The proposed indications include: in combination with FOLFIRI for RAS/RAF wild-type, recurrent or metastatic colorectal cancer after systemic treatment; in combination with mFOLFOX6 or FOLFIRI for RAS/RAF wild-type, left-sided, unresectable or metastatic colorectal cancer. Amivantamab is an investigational fully human bispecific antibody targeting EGFR and MET.

13. CStone Pharmaceuticals' "Sugemalimab" Receives Approval from the UK Medicines and Healthcare products Regulatory Agency

On October 31, CStone Pharmaceuticals announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved sugemalimab in combination with platinum-based chemotherapy for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) who have no EGFR-sensitive mutations or no ALK, ROS1, RET genomic tumor alterations. This marks the second marketing authorization approval for sugemalimab in international markets following the European Commission's approval.

14. YKYY015 Injection from Yuekang Pharmaceutical Approved for Clinical Trials

On October 31, Yooking Pharmaceuticals announced that its wholly-owned subsidiary, Tianlong Pharmaceuticals, had received the "Drug Clinical Trial Approval Notice" issued by the NMPA for the use of YKYY015 injection in treating patients with primary (familial and non-familial) hypercholesterolemia or mixed hyperlipidemia characterized by elevated LDL-C. It is reported that the ultra-long-acting lipid-lowering new drug YKYY015 injection is a small interfering ribonucleic acid (siRNA) drug independently developed by Tianlong Pharmaceuticals that targets the PCSK9 gene. The drug features an entirely new sequence and utilizes the company’s self-developed novel modification template for siRNA sequences.

15. Kelun Botai "Recombinant Human Interleukin-2 Injection" New Indication Submitted for Marketing Approval

On October 31, according to the CDE official website, the new indication marketing application for Recombinant Anti-EGFR Humanized Monoclonal Antibody Injection submitted by Kelun-Biotech was accepted. According to Kelun-Biotech's announcement, the indication applied for marketing this time is: for adult patients with locally advanced or metastatic non-small cell lung cancer harboring EGFR mutations whose disease has progressed after treatment with Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors (EGFR-TKI). This application was proposed to be included in the priority review by the CDE just a few days ago.

16. Novartis "PIT565" Submits Clinical Application in China

On November 1, according to the CDE official website, the clinical trial application for PIT565, a Class 1 new drug submitted by Novartis, was accepted. Public information indicates that this is a potential "first-in-class" tri-specific antibody targeting CD3/CD19/CD2 being developed by Novartis for the treatment of B-cell malignancies. Preclinical study results show that, compared with CD3 bispecific antibodies, PIT565 mediates a more effective and sustained anti-tumor T-cell response, with greater T-cell proliferation, cytokine production, and tumor cell lysis in vitro than bispecific antibodies.

17. Chipscreen Biosciences' "Theolyn" Combination Therapy Phase 3 Clinical Trial Approved by NMPA

On November 1, Chipscreen Biosciences announced that the NMPA has approved the Phase 3 clinical trial application for its self-developed original drug, Chiauranib, in combination with PD-(L)1 monoclonal antibodies and chemotherapy as a first-line treatment for extensive-stage small cell lung cancer. Chiauranib is a novel multi-target inhibitor developed by Chipscreen Biosciences, targeting Aurora B, VEGFR, PDGFR, c-Kit, and CSF1R.

18. Hansoh Pharma "AL01211 Capsule" Granted Breakthrough Therapy Designation

On November 1, according to the CDE official website, the AL01211 capsule submitted by Esliclin (Suzhou) Biopharmaceutical Co., Ltd. is proposed to be included in the breakthrough therapy designation for the indication of Fabry disease. Public information shows that this is an orally administered, non-brain-penetrating GCS (glucosylceramide synthase) inhibitor under development by AceLink Therapeutics. It has the potential to provide an oral small-molecule therapeutic option for Fabry disease patients who currently require frequent intravenous enzyme replacement therapy.

19. Huahai Pharmaceutical "HB0056 Injection" Approved for Clinical Trials in New Zealand

On November 1, Huahai Pharmaceutical announced that its subsidiary, Huaotai Bio, had received approval from New Zealand's Medicines and Medical Devices Safety Authority and the Health and Disability Ethics Committee to conduct a Phase 1 clinical trial of HB0056 injection in the local area. HB0056 is a bispecific antibody targeting both TSLP and IL-11, with the proposed indication being asthma.

20. Bristol-Myers Squibb "Nivolumab/Relatlimab Fixed-Dose Combination Injection" New Indication Approved for Clinical Trials

On November 1, according to the CDE official website, the fixed-dose combination injection of nivolumab/relatlimab submitted by Bristol-Myers Squibb has been granted a new clinical trial approval by default. It is intended for use in recurrent or metastatic non-squamous non-small cell lung cancer with tumor cell PD-L1 expression levels between 1% and 49%. Public information indicates that this is a fixed-dose combination therapy of LAG-3 targeted therapy and PD-1 inhibitor, which has already been approved by the U.S. FDA for the treatment of melanoma.

Global Pharmaceutical Transaction Dynamics

GSK Acquires a Novel Tri-specific Antibody for Autoimmune Diseases from Enmu Bio

On October 29, GSK announced the acquisition of CMG1A46 from Enmu Bio for a $300 million upfront payment. CMG1A46 is a clinical-stage CD19 and CD20-targeted T cell-engager (TCE). GSK plans to develop and commercialize CMG1A46 for B-cell-driven autoimmune diseases such as systemic lupus erythematosus (SLE) and lupus nephritis (LN), with potential expansion into related autoimmune conditions.

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Editor: Mu Mian

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