Novo Nordisk's Class 1 Chemical Drug NNC0519-0130 Injection for Diabetes Receives IND Approval in China

Pharmcube Data Weekly Selection (September 16 ~ September 22): Latest Developments in New Drug R&D, Including Progress Updates and Major Drug Transactions – All in One Quick Read.

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

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Novo Nordisk:
NNC0519-0130 Injection

On September 21, according to the CDE official website, the clinical trial application for NNC0519-0130 injection, a Class 1 chemical drug developed by Novo Nordisk, was accepted. Public information indicates that this drug is a once-weekly subcutaneous injectable GIP/GLP-1 dual agonist.

Source of the image: CDE official website

According to the ClinicalTrials website, Novo Nordisk has launched multiple clinical studies on NNC0519-0130 injection in the United States, Japan, Australia, South Korea, and other regions worldwide. Among them, two international multicenter Phase 2 clinical studies are currently underway: one focuses on the blood sugar-lowering effects in patients with type 2 diabetes (NCT06326047), and the other targets weight loss in overweight individuals (NCT06326060). Both studies are head-to-head against tirzepatide, with preliminary completion expected by November 2024.

Image Source: ClinicalTrials.gov

Upon the successful approval of the clinical trial application for NNC0519-0130 injection by the CDE, Novo Nordisk is expected to initiate further research on it in China.

Progress in the Development of Other New Drugs

1. Dizhe Pharmaceuticals "Suvoltinib Tablets" Debuts at ESMO Conference

On September 17, Dizhen Medicine announced that the latest global subgroup data from the international multi-center registration clinical study "WU-KONG1 Part B, WU-KONG1B" for its first self-developed novel lung cancer targeted drug, Shuwozhe® (generic name: Shuwotinib tablets), was presented at the 2024 European Society for Medical Oncology (ESMO) conference. The study showed that the second-line and subsequent treatment with Shuwotinib for EGFR exon 20 insertion mutation (exon20ins) non-small cell lung cancer (NSCLC) demonstrated consistent benefits across all subgroups compared to the overall global population.

2.Daiichi Sankyo/MSD "Patritumab Deruxtecan" Clinical Trial Reaches Endpoint

On September 18, Daiichi Sankyo and Merck announced positive results from the Phase 3 HERTHENA-Lung02 clinical trial of the ADC drug patritumab deruxtecan (HER3-DXd) for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR mutations who had previously received EGFR tyrosine kinase inhibitor (TKI) therapy. The analysis showed that the trial met its primary endpoint, with a significant improvement in progression-free survival (PFS) observed in patients receiving the ADC therapy.

3. SPH4336 Tablets by Shanghai Pharmaceuticals Approved for New Clinical Trials in Combination Therapy

On September 18, according to the CDE official website, the SPH4336 tablet submitted by Shanghai Pharmaceuticals received a new implied clinical trial approval. The proposed indication is for combination therapy with Osimertinib in treating KRAS-mutant advanced solid tumors. Public data shows that SPH4336 is a CDK4/6 inhibitor with broad-spectrum anti-tumor effects. It demonstrates high selectivity for the CDK4/6 target and also exhibits broad-spectrum activity against Rb-positive tumors. Osimertinib is an irreversible third-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI).

4. Aomu Pharmaceuticals/Xianju Pharmaceutical "Aomekesong Sodium Injection" Submission for Market Approval

On September 18, according to the CDE official website, the marketing application for Aom0498 Sodium Injection, a Class 1 new drug jointly submitted by Aomo Pharmaceuticals and Xianju Pharmaceutical, was accepted. According to Aomo Pharmaceuticals, Aom0498 Sodium (Aom0498) is a next-generation targeted muscle relaxant antagonist independently developed by the company. The product is a derivative of cyclodextrin that has been structurally modified by introducing chiral groups to shield carboxyl groups prone to triggering allergies, while enhancing its specificity, thereby reducing safety concerns such as hypersensitivity reactions.

5. Novartis "Kisqali" Approved for New Indication

On September 18, Novartis announced that the U.S. FDA had approved the CDK4/6 inhibitor Kisqali (ribociclib) in combination with an aromatase inhibitor (AI) as adjuvant treatment for patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) stage II and III early breast cancer (EBC) at high risk of recurrence, including patients without lymph node involvement (N0).

6. HUTCHMED "HMPL-760 Capsule" Approved for New Clinical Trial

On September 18, according to the CDE official website, Hutchmed's Class 1 new chemical drug HMPL-760 capsule received a new clinical trial implied permission. The indication is for combination with R-GemOx (rituximab + gemcitabine + oxaliplatin) in the treatment of relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL). Public data shows that HMPL-760 is a third-generation non-covalent BTK inhibitor, which demonstrated higher target specificity and efficacy than first-generation BTK inhibitors in preclinical studies.

7. Betta Pharmaceuticals "CFT8919 Capsule" Approved for Clinical Trials

On September 19, according to the CDE official website, the CFT8919 capsule submitted by Betta Pharmaceuticals received implied permission for clinical trials. It is intended to be developed for non-small cell lung cancer patients with EGFR mutations. Public data shows that this drug is an allosteric BiDAC™ (bifunctional protein) degrader with oral bioavailability co-developed by Betta Pharmaceuticals and C4 Therapeutics. In preclinical studies, CFT8919 demonstrated activity in both in vivo and in vitro models of EGFR L858R-driven NSCLC, targeting a broad range of on-target resistance mutations and exhibiting intracranial activity, showing potential for preventing or treating brain metastases in patients.

8. AstraZeneca's "Fasenra" Receives Another FDA Approval

On September 19, AstraZeneca announced that its key antibody therapy Fasenra (benralizumab) has received approval from the U.S. FDA for the treatment of adult patients with Eosinophilic Granulomatosis with Polyangiitis (EGPA). Fasenra is a monoclonal antibody that binds to IL-5Rα expressed on the surface of eosinophils. By binding to IL-5Rα, it is able to recruit natural killer cells and rapidly deplete these cells by inducing apoptosis in eosinophils. EGPA is a rare immune-mediated vasculitis that can cause multi-organ damage and may be fatal if left untreated.

9. Aligos "ALG-055009" Announces New Clinical Progress

On September 19, Aligos announced positive topline results from the Phase IIa HERALD study of its thyroid hormone receptor β (THR-β) agonist ALG-055009 in patients with metabolic dysfunction-associated steatohepatitis (MASH). At week 12, the median relative reduction in liver fat was as high as 46.2%, with a clear dose-response relationship.

10. Merck's "Keytruda" Combination Therapy Approved for New Indication

On September 19, Merck announced that the U.S. FDA had approved its重磅 PD-1 inhibitor Keytruda (pembrolizumab) in combination with pemetrexed and platinum-based chemotherapy as a first-line treatment for adult patients with unresectable advanced or metastatic malignant pleural mesothelioma (MPM). This approval was primarily based on data from the pivotal phase 2/3 IND.227/KEYNOTE-483 trial, in which Keytruda combined with chemotherapy demonstrated a statistically significant improvement in overall survival.

11. AbbVie Launches Phase III Clinical Trial of "Epcoritamab" in China

On September 19, according to the Drug Clinical Trial Registration and Information Disclosure Platform, AbbVie registered a Phase III clinical trial to evaluate the safety and efficacy of Epcoritamab + Rituximab and Lenalidomide compared with chemoimmunotherapy in previously untreated follicular lymphoma subjects. Epcoritamab is a CD20×CD3 bispecific antibody that was approved for marketing by the FDA on May 19, 2023.

12. CANbridge's "Velaglucerase Alfa for Injection" Granted Priority Review

On September 19, according to the CDE official website, Canbridge's Velaglucerase Alfa for Injection is proposed for priority review. It is applicable for long-term enzyme replacement therapy (ERT) in patients diagnosed with Gaucher disease type I (GD1) and type III (GD3). Public information shows that this drug is CAN103, an enzyme replacement therapy developed by Canbridge for Gaucher disease. Recently, a pivotal clinical trial of this product in treatment-naïve subjects aged 12 years and above with type I and type III Gaucher disease achieved positive topline results. Canbridge previously stated that it would submit an NDA application in the fourth quarter of 2024.

13. Leap Therapeutics' "Injectable Verubercotamab" Granted Priority Review

On September 19, according to the CDE official website, Lepu Biopharma's injectable Verucotumab is proposed for priority review. It is applicable for patients with recurrent/metastatic nasopharyngeal carcinoma who have failed at least two prior lines of systemic chemotherapy and PD-1/PD-L1 inhibitor treatments. Public information indicates that this drug is an antibody-drug conjugate (ADC) targeting EGFR developed by Lepu Biopharma, with the research and development code MRG003. The molecular design of this drug has the potential to expand its application to a broader range of cancer types characterized by EGFR overexpression, and it also has the potential to overcome various types of resistance caused by common mutations.

14. Johnson & Johnson "Bleximenib Capsules" Approved for Clinical Use

On September 19, according to the CDE official website, Johnson & Johnson's Class 1 new drug bleximenib capsule has been approved for clinical trials. It is intended for the treatment of adult patients with relapsed/refractory acute myeloid leukemia (AML) carrying histone-lysine N-methyltransferase 2A rearrangement (KMT2Ar) or nucleophosmin 1 gene mutation (NPM1m). Public data shows that bleximenib is a Menin-KMT2A interaction inhibitor, currently undergoing Phase 1/2 clinical studies internationally.

15. Hengrui Medicine "Relafusp-α" Submits for Market Approval

On September 19, Hengrui Medicine announced that the marketing authorization application for its Relafusp-alpha (SHR-1701) has been accepted by the National Medical Products Administration (NMPA), indicated for first-line treatment in combination with fluorouracil and platinum-based drugs for locally advanced unresectable, recurrent, or metastatic gastric and gastroesophageal junction adenocarcinoma. Relafusp-alpha Injection is a bifunctional fusion protein targeting PD-L1/TGF-βRII independently developed by Hengrui Medicine. It promotes the activation of effector T cells while effectively modulating immune regulation within the tumor microenvironment, ultimately enhancing the immune system's ability to kill tumor cells.

16. BeiGene "BGB-C354" Approved for Clinical Trials

On September 20, according to the CDE official website, BeiGene's Class 1 new drug, BGB-C354 for injection, has been approved for clinical trials, intended for the treatment of patients with advanced solid tumors. Public information shows that BGB-C354 is an ADC drug targeting B7-H3, and represents a new molecular entity developed by BeiGene in the field of solid tumors. Previously, BeiGene had already initiated a Phase 1 clinical study in the United States and Australia to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of BGB-C354 as a monotherapy or in combination with the anti-PD-1 antibody tislelizumab in patients with advanced solid tumors.

17. Roche's "Xofluza" Discloses New Clinical Progress

On September 20, Genentech, a member of the Roche Group, announced that the antiviral therapy Xofluza (baloxavir marboxil) met the primary endpoint in the phase 3 clinical trial CENTERSTONE. Data showed that a single oral dose of Xofluza significantly reduced the likelihood of household members contracting the influenza virus when administered to individuals infected with the flu. Xofluza was well-tolerated, with no new safety signals identified.

18. Baili Tianheng "GNC-077 Multispecific Antibody Injection" Approved for Clinical Trials

On September 20, according to the CDE official website, Baili Tianhe's GNC-077 multispecific antibody injection has been approved for clinical trials. It is intended for use in solid tumors, including but not limited to non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), nasopharyngeal carcinoma (NPC), head and neck cancer (HNC), esophageal cancer (EC), colorectal cancer (CRC), and breast cancer (BC). According to Baili Tianhe's prospectus, this drug is an innovative multispecific antibody molecule developed by Baili Tianhe based on its multispecific antibody development platform (GNC platform).

19. Akeso Bio "AK137 Injection" Approved for Clinical Trials

On September 20, according to the CDE official website, Akeso Biopharma's AK137 injection has been approved for clinical trials, with the indication being advanced malignant tumors. Public data shows that AK137 injection is a CD73/LAG-3 bispecific antibody. Studies indicate that the inhibition of CD73 combined with immune checkpoint blockade, targeted therapy, or conventional treatment can enhance antitumor effects in various mouse cancer models; LAG-3 plays an important role in regulating T-cell expansion and function, and blocking LAG-3 with monoclonal antibodies can enhance T-cell function in multiple models.

20. Chengdian Bio "CD-001" Approved for Clinical Trials in the U.S.

On September 20, Chellic Biopharma announced that its self-developed IL-21 fusion protein drug CD-001, which targets tumor-reactive CD8+ T cells, has received clinical default approval from the U.S. FDA. CD-001 is an IL-21 fusion protein drug independently developed by Chellic Biopharma to address the current low efficiency of clinical PD-1 inhibitor tumor treatments. While blocking the PD-1 immunosuppressive signal, the drug selectively expands tumor-reactive CD8+ T cells in vivo, significantly enhancing the efficacy of immunotherapy.

Global Pharmaceutical Trading Dynamics

1. Organon Introduces Innovative Therapy Vtama Cream

On September 19, Organon and Dermavant Sciences announced that they had entered into a definitive agreement under which Organon will acquire Dermavant and obtain its innovative therapy, Vtama (tapinarof) cream. According to the terms of the agreement, the total value of the acquisition is approximately $1.2 billion, including a $175 million upfront payment, $75 million in regulatory milestone payments, and $950 million in certain commercial milestone payments. The press release stated that this transaction will help realize the potential of Vtama on a global scale.

2. Huadong Medicine and HuiSheng Biotech Reach Cooperation on HuiYouJing

On September 20, Huadong Medicine and Huisheng Bio, a non-wholly owned subsidiary of Sihe Pharma, reached an exclusive strategic cooperation for the commercialization rights of the marketed innovative product Huiyoujing (Proline/Gliflozin Tablets) in mainland China. Huiyoujing (Proline/Gliflozin Tablets), developed by Huisheng Bio for the treatment of type 2 diabetes, is an SGLT-2 inhibitor and a self-owned intellectual property Class 1 new drug. According to the agreement terms, Huadong Medicine will be responsible for the commercial market promotion of Huiyoujing in mainland China, while Huisheng Bio, as the MAH holder, will handle the registration, clinical development, production, and supply of Huiyoujing.

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Editor: Mu Mian

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