Eli Lilly, Kangtai Bio and Others Secure Approvals in China; Multiple New Drugs Filed for Marketing Authorization

▎WuXi AppTec Content Team Report

This week, the field of innovative drug research and development has seen many advancements.. For example:Eli LillyShenzhen Kangtai Biological Products Co., Ltd.Products from Mundi Pharma and other companies approved for marketing in China; multiple new drugs submitted for marketing application in China；Grand Pharmaceutical, InnoCare, PrimeGene, Akeso and other companies announced positive clinical results for their research products.。This article will provide a brief introduction to some of the important advancements, for readers' reference only.

Note: This table is compiled by "MedView" based on publicly available information. The table only lists some of the new drug developments from this week and is for reference only.

———✦Registration Progress✦———

China's National Medical Products Administration (NMPA) announced on its official website that two diabetes treatment products from Eli Lilly and Company have been approved in China: Dulaglutide Injection and Insulin Glargine Injection. Among them,Dulaglutide has been approved for a new indication this time. It is a long-acting GLP-1 receptor agonist administered once weekly.`, which can effectively reduce glycated hemoglobin (HbA1c).`Insulin glargine is aLong-acting basal insulin analogs,Patients with Type 1 DiabetesOnly needs to be administered once daily。

The NMPA official website announced that the fluticasone/formoterol inhalation aerosol applied for by Mundipharma has been officially approved. Public information shows that this product isA combination drug that mixes fluticasone and formoterol in a single inhaler, which can take effect rapidly within 1 to 3 minutes.It has previously been approved for use in treating asthma in the Hong Kong region of China. One of its combination components, fluticasone, is an inhaled corticosteroid, and the other component, formoterol, is a long-acting beta2-receptor agonist belonging to the class of long-acting bronchodilators.

As announced on the NMPA official website, Minhai Biotechnology Co., Ltd., a wholly-owned subsidiary of Shenzhen Kangtai Biological Products Co., Ltd., has submittedLyophilized Human Rabies Vaccine (Human Diploid Cell)The marketing application has been approved for use inPrevention of RabiesPublic data shows that this vaccine is prepared using human diploid cells and adopts two immunization regimens: the "5-dose method" and the "2-1-1" (four-dose method). Clinical results indicate that both immunization regimens have demonstrated good safety, immunogenicity, and long-lasting immunity after full vaccination.

China's National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) announced on its official website that Qilu Pharmaceutical Co., Ltd. has submitted a marketing application for Aipalorilimab Injection, a Class 1 new drug, which has been accepted. According to public information,Iparomlimab isA TargetedIgG4 Antibody of PD-1, is being developed for the treatment of various cancers. Previously, it was associated with targetedThe immunotherapy combination antibody QL1706, composed of the IgG1 antibody tuvonralimab targeting CTLA-4, has been submitted for marketing approval in China.

Dizal Pharmaceutical announced that its self-developedHighly Selective JAK1 InhibitorThe new drug application for Golixitinib has been officially accepted by the CDE forRecurrent/Refractory Peripheral T-cell Lymphoma (r/r PTCL)Treatment. This application is based on the results of the international multicenter pivotal clinical trial (Part B of JACKPOT8) for this product, with the primary endpoint assessed by the Independent Radiology Review Committee (IRC).Objective Response Rate (ORR) reached 44.3%, and Complete Response (CR) rate reached 23.9%.。

CDE official website announced that Marinus Pharmaceuticals and Yuanyi Biotechnology, among others, have submitted a new drug marketing application for ganaxolone oral suspension. According to public information,Ganaxolone is a positive allosteric modulator targeting the GABAA receptor.Yuanyi Biotechnology (Shanghai) Co., Ltd. has secured exclusive rights for the development and commercialization of Ganaxolone Oral Suspension in Greater China through a collaboration exceeding $260 million.Proposed for Priority Review by CDE, for the treatment of seizures in patients aged 2 years and older with Cyclin-Dependent Kinase 5 (CDKL5) Deficiency Disorder (CDD).

CDE Official Website Announcement: The marketing application for Teclistamab Injection submitted by Johnson & Johnson is proposed to be included in the priority review. The proposed indication is monotherapy for adult patients with relapsed or refractory multiple myeloma who have previously received at least three prior lines of therapy. Public information shows,Teclistamab, a "first-in-class" bispecific antibody therapy targeting BCMA and CD3, has been approved for marketing in the European Union and the United States., and in ChinaIncluded in the Breakthrough Therapy Designation, for the treatment of adult patients with relapsed or refractory multiple myeloma.

Haisco announced that its new neuropathic pain drug HSK16149 capsule is used forPostherpetic NeuralgiaThe new indication marketing application has been accepted by the CDE. Previously, the company had submitted a new drug marketing application for the indication of "diabetic peripheral neuropathic pain."HSK16149 capsule is a calcium channel modulator developed by Haisco., with high target selectivity, good analgesic effects, long-lasting pain relief, and excellent safety in the central nervous system. Previously, this product has reached the primary efficacy endpoint in confirmatory clinical trials for postherpetic neuralgia, and its overall safety profile was well-controlled.

Livzon Pharmaceutical Group Inc. announced that its wholly-owned subsidiary, ZHUHAI LIVZON MICROSPHERE TECHNOLOGY CO.LTD, has filed an application forAripiprazole Microspheres for InjectionThe listing application has been accepted.This is a long-acting sustained-release formulation, administered once a month, indicated for adult schizophrenia.Aripiprazole is a novel atypical antipsychotic drug, acting as a partial agonist at D2 and 5-HT1A receptors and as an antagonist at 5-HT2A receptors. Injectable aripiprazole microspheres offer a more stable blood concentration compared to conventional formulations, reducing the frequency of administration and improving medication adherence.

Salubris announced that it has submitted the marketing application for Alisartan Indapamide Sustained-Release Tablets and obtained acceptance, with the proposed indication beingPrimary Hypertension。Alisartan Indapamide Sustained-Release Tablets (Project Code: SAL0108) is an ARB/diuretic compound sustained-release formulation.Among them, Alisartan ester is an angiotensin II receptor antagonist, and Indapamide is a sulfonamide diuretic with diuretic and calcium channel blocking effects.

Kelun Pharmaceuticals announced that A140 Injection (brand name: Datai), a biosimilar of Cetuximab developed by its holding subsidiary Kelun-Biotech, has been submitted for marketing approval and accepted by the CDE for the treatment of...RASGene Wild-TypeMetastatic Colorectal CancerAndSquamous Cell Carcinoma of the Head and NeckA140 isA recombinant anti-epidermal growth factor receptor (EGFR) human-mouse chimeric monoclonal antibody that can inhibit the growth and survival of tumor cells expressing EGFR.。

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———✦Clinical Progress✦———

Grand Pharmaceutical Group Limited announced that itsCompound Nasal Spray of Antihistamines and CorticosteroidsGSP 301 NS Clinical Trial in China for the Treatment of Patients Aged 12 Years and AboveSeasonal Allergic Rhinitis (SAR)The Phase 3 clinical study (GSP 301-308) has been completed and met the primary endpoint. The total score reduction in reflex nasal symptoms (rTNSS) in the trial group was significantly greater than that in the control group, demonstrating that GSP 301 NS efficacy scores were superior to the original single-agent formulation. Additionally, the safety, tolerability, and pharmacokinetic characteristics of the product also achieved the pre-set clinical endpoints.

Tonghua Golden-Horse Pharmaceutical Industry Co., Ltd. announced that a preparatory meeting for the Phase 3 clinical trial unblinding of its self-developed Succinyl Octahydro Amide Tablets, conducted in collaboration with its wholly-owned subsidiary, was held, officially completing the blinded data review.Huperzine A Tablets are a new type of cholinesterase inhibitor with dual cholinesterase inhibition functions., which can simultaneously inhibit acetylcholinesterase and butyrylcholinesterase, for the treatment ofMild to Moderate Alzheimer's DiseaseTonghua Golden-Horse Pharmaceutical Industey Co., Ltd. stated in the announcement that the company will further complete the database lock, unblinding, and statistical analysis of the main data, as well as the registration preparation work for the marketing authorization application of this project.

Asieris Pharmaceuticals Announces that itsOrally Reversible MetAP2 InhibitorAPL-1202 in combination with the PD-1 inhibitor Tislelizumab asNeoadjuvant Therapy for Muscle-Invasive Bladder Cancer (MIBC)The Phase 1/2 clinical trial completed the interim analysis of the Phase 2 clinical trial and achieved positive results. In the trial, both the combination therapy group and the tislelizumab treatment group met the efficacy requirements for the first stage of the Simon two-stage optimal design. After reviewing the interim analysis data, the Safety Monitoring Committee (SMC) determined that...The interim analysis results met the pre-specified requirements of the protocol.。

InnoCare Announces Publication in the American Journal of HematologyBTK InhibitorOrelabrutinib TreatmentRelapsed/Refractory Marginal Zone Lymphoma (MZL)Clinical study results of the patient. At a median follow-up of 24.3 months, assessed by the Independent Review Committee (IRC),The overall response rate (ORR) reached 58.9%, with 92.2% of patients observing tumor shrinkage.The median duration of response (DoR) assessed by IRC was 34.3 months, and the median progression-free survival (PFS) has not yet been reached. The 12-month PFS rate and overall survival (OS) rate were 82.8% and 91.0%, respectively. This indicates that orelabrutinib induced deep responses in patients with relapsed/refractory MZL and demonstrated a favorable safety profile.

PrimeGene Therapeutics Co., Ltd. released a press release stating that the company has developedJAK InhibitorsPG-011 Gel (Pumextinib Gel) Completes TreatmentPrurigo NodularisPhase 2 Clinical Study Achieves Expected Goals. After 4 weeks of treatment with three times daily dosing, the proportion of subjects in the treatment group who achieved a clinically meaningful reduction in itching, as well as the proportion of subjects with significant nodule area reduction, were both significantly better than the placebo group, demonstrating the therapeutic potential of PrimeGene’s Pumeixitin Gel in anti-inflammation, itch relief, and immune modulation.

Akeso announced that its self-developedNovel IL-4Rα Monoclonal AntibodyAK120 TreatmentModerate to Severe Atopic Dermatitis (AD)Phase 1 clinical research results were published in Dermatology and Therapy. The results showed that AK120 was safe and tolerable for patients with moderate to severe atopic dermatitis, and...Effectively inhibits the IL-4/IL-13 signaling pathway and significantly improves skin lesion status in AD patients., preliminary efficacy suggests a promising clinical outlook. Currently, Akeso is accelerating the Phase 3 registrational clinical study of AK120 for the treatment of moderate to severe atopic dermatitis.

Public information shows that several new drugs under development by Chinese companies have been approved for clinical trials overseas. For example,AbbiskoInnovative CSF-1R Inhibitor Pimicotinib (ABSK021) Approved for Multicenter Phase 3 Clinical Trial in Europe, Intended for Development to Treat Tenosynovial Giant Cell Tumor;Weijiu BiotechnologyOral Small Molecule NLRP3 Inhibitor Approved for Clinical Trials in the U.S., Intended for Development to Treat Degenerative Diseases Associated with Central Nervous System Inflammation;IMPACT TherapeuticsPARP1 Selective Inhibitor IMP1734 Co-developed with Eikon TherapeuticsApproved for clinical trials in the U.S., intended for cancer treatment development。

The official website of the Chinese Drug Clinical Trial Registration and Information Disclosure Platform shows that CHIATAI TIANQING, Inventiva, and other companies have initiated an international multicenter Phase 3 clinical study to evaluate lanifibranor inNonalcoholic Steatohepatitis (NASH)Efficacy and safety in adult subjects. Public information shows that lanifibranor, developed by Inventiva Pharma, was introduced by CHIATAI TIANQING for over 50 million US dollars.An oral PPAR agonist that was previously included in the breakthrough therapy category by the CDE., intended for development to treat adult patients with NASH without cirrhosis but with liver fibrosis.

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———✦Licensing Collaboration & Emerging Financing✦———

Kelun-Biotech announced that it has reached an agreement with the Affiliated Hospital of Southwest Medical University regardingBone-targetedRadiopharmaceutical Conjugate TBM-001 Secures Exclusive Licensing Agreement, Granting Global Exclusive Rights to the Product. The collaboration involves an amount reaching 38.5 million yuan. TBM-001 was independently developed by Professor Chen Yue's team from the Department of Nuclear Medicine at the Affiliated Hospital of Southwest Medical University and is intended for...Early Diagnosis and Precise Targeted Treatment of Bone MetastasisTheRadiopharmaceutical Conjugates (RDC) Products, which has previously demonstrated superior efficacy and safety compared to existing bone metastasis radiopharmaceuticals in the imaging diagnosis and treatment of advanced prostate cancer, breast cancer, lung cancer, and other malignant tumor bone metastases.

Exelixis and Insilico Medicine Announce Exclusive License Agreement for ISM3091; Insilico Medicine to Receive $80 Million Upfront PaymentISM3091 is a potential "best-in-class" small molecule inhibitor targetingBRCASynthetic Lethal Target USP1 in Mutant Tumors, which was approved by the FDA in April 2023 to conduct clinical trials in the solid tumor patient population.

Hangzhou Newanjin Biotechnology Co., Ltd. and Boai NKY Medical Holdings Ltd. Sign Investment Agreement, Taking the LeadCompleted the closing of a new round of financing worth 50 million yuan.. This round of financing will boost the independently developed projects of Hangzhou Newanjin Biotechnology Co., Ltd.Personalized Tumor Therapeutic Peptide VaccinePhase 1 Clinical Trial of Injectable P01Personalized Tumor Therapeutic mRNA VaccineThe investigator-initiated clinical trial (IIT) of iNeo-Vac-R01, and the rapid advancement of other pipelines.