Multiple New Drugs from Johnson & Johnson, Novartis, Akeso, and Qilu Pharma Submitted for Market Approval in China in August

Sep 04, 2023 17:47 CST Updated 17:47

Astellas

Pharmaceutical R&D Manufacturer

Akeso

Innovative Antibody Drug Developer

FibroGen

Developer of Oral Small Molecule Inhibitors

Yichang HEC Changjiang Pharmaceutical

Therapeutic Area Product Development and Manufacturing

Luye Pharma

Innovative Drug Developer

Novartis

Drug Development and Manufacturing

Qilu Pharmaceutical

Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer

Simcere

Innovative Drug Developer

Janssen Pharmaceuticals

Pharmaceutical R&D Developer

Eli Lilly

Global Pharmaceutical R&D and Production Company

Hengrui Pharma

Innovative and High-Quality Pharmaceutical Developer

Livzon

Pharmaceutical R&D, Manufacturing, and Sales Enterprises

IMPACT Therapeutics

Targeted Anti-Cancer Innovative Drug Developer

Junshi Biosciences

Innovative Drug Developer

BeOne

Developer of Molecular Targeted and Immune Anti-Tumor Drugs

XZenith Biopharm

Researcher and Developer of New Molecular Entity Drugs

▎WuXi AppTec Content Team Report

According to the public information from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China, in August, many new drugs submitted marketing applications or supplementary applications for new indications in China.（(Excluding vaccines and biosimilars). After analyzing these products, we have the following findings:Many of these new drugs are dual-target products., such asPD-1/VEGFBispecific antibodies, BCMA/CD3 bispecific antibodies, PD-1/CTLA-4 combination antibodies, IL-12/IL-23 antibodies, GIP/GLP-1 receptor agonists, etc.;Multiple Companies Submit Marketing Applications for Two New Drugs, such as HEC CJ PHARM, Akeso, and Hengrui Pharma, etc.;Multiple New Overseas Drugs Are Accelerating Entry Into China, such as Astellas' anti-Claudin 18.2 antibody, Novartis' next-generation anti-VEGF antibody,FibroGen Anemia Therapyetc.This article will share some of the new drug information, for readers' reference only.

Astellas：Zolbetuximab for Injection

Mechanism of Action:Anti-Claudin 18.2 Antibody

On August 1, Astellas Pharma announced that the CDE had accepted itsAnti-Claudin 18.2 AntibodyZolbetuximab for Injection (zolbetuximab）The listing application forFirst-line treatment for CLDN18.2-positive, HER2-negative locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma patients。Zolbetuximab for InjectionIt is an IgG1 monoclonal antibody that specifically binds to CLDN18.2 on the surface of tumor cells, thereby exerting its anti-tumor effect.This YearJuly`, the product`The Biologics License Application (BLA) for first-line treatment of GEJ adenocarcinoma patients has been accepted by the United States.FDA Acceptance, and received priority review status.

Akeso:Ivonescimab

Mechanism of Action: PD-1/VEGF Bispecific Antibody

August 1,AkesoPD-1/VEGF Bispecific Antibody EwoxiSubmission of New Drug Marketing ApplicationAccepted by the CDE, the application was alsoProposed for Priority Review, for the indication: in combination with pemetrexed and carboplatin for use after disease progression following treatment with EGFR tyrosine kinase inhibitors (EGFR-TKI).EGFRTreatment of Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC) with Mutations。Ivonescimab (AK112/SMT112)Can block the binding of PD-1 to PD-L1 and PD-L2, and simultaneously block the binding of VEGF to VEGF receptors.Previously, IvonescimabHas been included in the CDE's breakthrough therapy category three times successively., including the indications that have been submitted for marketing approval and are proposed for priority review in this instance.

FibroGen:Roxadustat Capsules

Mechanism of Action:Hypoxia-Inducible Factor Prolyl Hydroxylase Inhibitor (HIF-PHI)

On August 2, the new indication application for Roxadustat Capsules submitted by FibroGen was accepted by the CDE. Public information shows that Roxadustat (roxadustat) isAn orally administered small-molecule hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), which was previously approved in China for the treatment of anemia caused by chronic kidney disease. In May this year, roxadustat was approved in China for the treatment ofChemotherapy-Induced AnemiaThe pivotal Phase 3 clinical trial met the primary endpoint of non-inferiority compared to epoetin alfa, and FibroGen stated in a press release that it plans to submit a new drug application for the additional indication in China.

HEC CJ PHARM: AnTaiTaWei Phosphate Capsules,IMPACT Therapeutics Tablets

Mechanism of Action:Direct-acting Antiviral Drugs

On August 2 and August 15, the CDE successively acceptedHEC CJ PHARM Class 1 New DrugAntivir Phosphate CapsulesAndIMPACT Therapeutics TabletsThe listing application. According toHEC CJ PHARM Announcement,IMPACT TherapeuticsA Pan-genotypic Chronic Hepatitis C Treatment Direct-Acting Antiviral (DAA) NS5B Polymerase Inhibitor, the productIn combination with Antelovir capsules for the treatment of naive or interferon-experienced adults with chronic hepatitis C virus (HCV) genotype 1, 2, 3, or 6 infection, with or without compensated cirrhosis.。This new drug marketing application is mainly based on the results of Phase 2/3 clinical trials of Yinquangbuvir combined with Antahevir capsules. The study met the primary efficacy endpoint, with a 12-week sustained virologic response rate (SVR12) reaching 95%, and overall safety was well-controlled.

Luye Pharma:Injectable Rotigotine Sustained-Release Microspheres

Mechanism of Action:Dopamine Receptor Agonist

On August 1, Luye Pharma announced,Once weekly administrationThe marketing application for Luye Pharma's rotigotine sustained-release microspheres for injection (LY03003) has been accepted by the CDE.And has been granted priority review for the treatment of Parkinson's disease.。LY03003 is a weekly formulation that provides continuous dopaminergic stimulation (CDS), overcoming the non-physiological pulsatile stimulation caused by short-acting dopaminergic drugs. It exhibits significant characteristics of a sustained-release formulation after intramuscular injection.According to the press release from Luye Pharma, this timeLY03003The marketing application is based on multiple Phase 1 clinical trials and one Phase 3 clinical trial, with results demonstrating the drug's efficacy in treating Parkinson's disease.Safe and effective, can comprehensively and continuously improve motor symptoms in Parkinson's disease patients, enhancing their quality of life.。

Novartis: Brolucizumab Injection

Mechanism of Action:Next-Generation Anti-VEGF Antibody

On August 2, the new drug marketing application for brolucizumab injection submitted by Novartis was accepted by the CDE. Public information shows that brolucizumab (RTH258) isInnovative Next-Generation Ophthalmic Drug Targeting VEGF Inhibition, by inhibiting the VEGF signaling pathway, thereby suppressing the growth of neovascular lesions, clearing retinal edema, and improving the patient's vision.。Previously, the drugHas been approved overseas for the treatment of wet age-related macular degeneration (AMD) and diabetic macular edema (DME)., and has been approved for prioritized clinical urgent use in medical institutions within China's Guangdong-Hong Kong-Macao Greater Bay Area.

Qilu Pharmaceutical:QL1706

Mechanism of Action: PD-1/CTLA-4 Combination Antibody

On August 12, Qilu Pharmaceutical Co., Ltd. filed a Class 1 new drugEpaloprolizumab Tovorolizumab InjectionThe listing application has been accepted by the CDE. According to public information from Qilu Pharmaceutical, this is itsImmune Combination Antibody QL1706 (Aipalolizumab/Tovorolizumab)，It has the synergistic mechanism of simultaneously blocking PD-1 and CTLA-4, while reducing the toxicity caused by the CTLA-4 antibody. Currently,QL1706 Combined with Chemotherapy inFirst-line treatment for cervical cancer, adjuvant treatment for non-small cell lung cancer, first-line treatment for advanced non-small cell lung cancer (NSCLC), and first-line treatment for nasopharyngeal cancer...and other aspects, multiple Phase 3 clinical studies have been conducted.

Simcere: Trilaciclib Hydrochloride for Injection

Mechanism of Action: CDK4/6 Inhibitor

On August 14, Simcere announced in a public notice that,CDK4/6 InhibitorsThe new indication application for Trilaciclib Hydrochloride for Injection has been accepted by the CDE forExtensive-Stage Small Cell Lung Cancer (ES-SCLC)Patients were pre-treated with a topotecan-containing regimen to reduce the incidence of chemotherapy-induced myelosuppression.Trilaciclib hydrochloride is a CDK4/6 inhibitor developed by G1 Therapeutics. Simcere owns the development and commercialization rights for all indications in Greater China. Previously, this productHas been granted conditional approval for marketing in China,For the treatment of ES-SCLC patients who have not previously received systemic chemotherapy.

Janssen: Telitacicept Injection

Mechanism of Action: BCMA/CD3 Bispecific Antibody

On August 19, the marketing application for Teclistamab Injection submitted by Janssen, a subsidiary of Johnson & Johnson, was accepted by the CDE. Public information shows that Teclistamab isA "first-in-class" bispecific antibody therapy targeting BCMA and CD3It can recruit CD3-positive T cells to the vicinity of myeloma cells expressing BCMA and activate T cells to attack tumor cells.Previously, the drugHas been approved for marketing in the EU and the US, and in ChinaIncluded in the Breakthrough Therapy Designation, for the treatment of adult patients with relapsed or refractory multiple myeloma.

Eli Lilly: Tirzepatide Injection

Mechanism of Action: GIP/GLP-1 Receptor Agonist

On August 21, Eli Lilly and Company submitted a new indication listing application for tirzepatide injection in China, which was accepted by the CDE, for improving adult obesity or conditions associated with at least one weight-related comorbidity, based on a low-calorie diet and increased exercise.Long-term Weight Management for Overweight Patients。TirzepatideYesA glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist, has been approved in multiple overseas regions for improving blood glucose control in adult patients with type 2 diabetes.In September 2022, Eli Lilly submitted a marketing application in China for the drug to be used in blood glucose control in adult patients with type 2 diabetes.

Hengrui Pharma: Fluazoparib Capsules

Mechanism of Action:PARP Inhibitor

On August 22, Hengru Pharma announced that the new indication application for Fuzoparib Capsules had been accepted by the CDE.For maintenance treatment of patients with advanced epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have achieved complete or partial response after first-line platinum-based chemotherapy.。Fluzoparib isA Novel Oral PARP Inhibitor`, can specifically kill`BRCAMutated tumor cells. Previously, the drug has been approved in China for the treatment of specific ovarian cancer. This new indication application for Fuzolaparib is based on the results of a phase 3 trial named FZPL-III-302. In this trial, Fuzolaparib significantly prolonged patients' progression-free survival and reduced the risk of disease progression/death.

Akeso:Eptinezumab Injection

Mechanism of Action: IL-12/IL-23 Antibody

August 24,Akeso announced that itsFully Human Monoclonal Antibody Targeting IL-12/IL-23The marketing application of Eptinezumab has been accepted by the CDE.For the treatment of moderate to severe plaque psoriasis。Evolocumab（AK101）Targeting the p40 subunit of IL-12 and IL-23 and binding to it,By inhibiting Th1 and Th17 mediated abnormal immune responses, thereby achieving the purpose of treating psoriasis.Two pivotal Phase 3 clinical studies have shown,Elirocumab Shows Significant Efficacy at 16 and 52 Weeks in Moderate to Severe Plaque Psoriasis TreatmentWhile effectively improving skin lesions, it also significantly enhanced the patients' quality of life, andGood safety profile.

Livzon Pharmaceutical: Triptorelin Acetate Microspheres for Injection

Mechanism of Action:GnRH Agonist

On August 25, Livzon Pharmaceutical Group Inc. announced that the new indication application for its Triptorelin Acetate Microspheres for Injection has been accepted by the CDE for...Treatment of Endometriosis. Public information shows that the injection of triptorelin acetate microspheres isA gonadotropin-releasing hormone (GnRH) agonist administered as a monthly intramuscular injection, which was approved in May 2023 for prostate cancer patients requiring androgen deprivation therapy.Compared with ordinary injections, this triptorelin microsphereWith characteristics such as a long onset time and reduced dosing frequency, it can alleviate patient suffering and the burden of medication, improving medication tolerance and accessibility.

Hengrui Pharma:Emapitini Sulfate Tablets

Mechanism of Action:JAK1 Inhibitor

August 24,Hengrui Pharma submittedThe new indication marketing application for Class 1 innovative drug Imasitinib Sulfate Tablets has been accepted by the CDE for patients with inadequate response or intolerance to nonsteroidal anti-inflammatory drugs (NSAIDs).Active Ankylosing SpondylitisAdult patients. Public information shows that IMAbrutinib (SHR0302) is aNext-Generation JAK1 Inhibitor，Characterized by high selectivity, high efficiency, and an extended plasma half-life,Can exert anti-inflammatory and immunosuppressive biological effects by inhibiting JAK1 signaling.. Previously, the productOnce designated as a breakthrough therapy by the CDE, a new drug application for the treatment of moderate to severe atopic dermatitis has been submitted.。

IMPACT Therapeutics/Junshi Biosciences:senaparib

Mechanism of Action: PARP Inhibitor

News on August 26, IMPACT Therapeutics andJunshi BiosciencesCo-developedPARP Inhibitor Senaparib(Product code: JS109/IMP4297) has been accepted by the CDE for new drug marketing application.For maintenance treatment in patients with International Federation of Gynecology and Obstetrics (FIGO) stage III-IV epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have achieved complete or partial response to first-line platinum-based chemotherapy.。This new drug marketing application is mainly based onA randomized, double-blind, placebo-controlled, multi-center Phase 3 clinical studyFLAMES StudyResults. The study shows,Senaparib significantly extended progression-free survival (PFS) in patients with advanced ovarian cancer, regardless of their breast cancer susceptibility gene (BRCA) Regardless of expression, patients can benefit.。

BeOne Medicines: Tislelizumab Injection

Mechanism of Action:Anti-PD-1 Monoclonal Antibody

On August 30, BeOne Medicines submittedAnti-PD-1 monoclonal antibodyThe new indication marketing application for Tislelizumab Injection has been accepted by the CDE. According to public information,This is the 13th marketing authorization application for an indication submitted in China for this product.`, the drug has previously been approved for 11 indications in China.`According to the financial results for the second quarter of 2023 released by BeOne Medicines on August 2, the expected milestone event for Tislelizumab is: submission in China for...First-line Treatment for Extensive-Stage Small Cell Lung CancerThe registration and application work.Tislelizumab Combined with Chemotherapy for Untreated ES-SCLC PatientsPhase 3 Clinical Trial RATIONALE-312 Has Reached the Primary Endpoint, compared with chemotherapy,Combination Therapy Demonstrates Superior Overall Survival (OS) in Untreated ES-SCLC Patients。

XZenith Biopharm:Piroxanib

Agent Formulation:CDK4/6 Inhibitors

On August 30, XZenith Biopharm, a subsidiary of Hengrui Pharma, is currently researchingCDK4/6 InhibitorsPiroxanib submitted for marketing approval in China and was accepted by the CDE. According to the recent half-year financial report released by Four Rings Medicine,XZenith BiopharmBlockbuster ProductBiroxini Combined with Fulvestrant as Second-Line TreatmentThe interim analysis of the Phase 3 clinical trial met the expected goals, and the NDA application was submitted in July.Piroxanib (bIrociclib, XZP-3287) isA CDK4/6 inhibitor with a novel structure, featuring unique pharmacokinetic properties that enable effective penetration through the blood-brain barrier. It is expected to produce favorable efficacy in patients with breast cancer brain metastases and brain cancer.

In addition to the aforementioned drugs, some new drugs also submitted their marketing applications to the CDE in August and were accepted.。Due to space limitations, this article will not introduce them one by one. Hopefully, these new drugs will be approved in China as soon as possible, bringing new treatment options to a wide range of patients.

References: (Swipe up and down to view)

[1] China's National Medical Products Administration Accepts Astellas' Zolbetuximab Biologics License Application. Retrieved Aug 1，2023, from https://mp.weixin.qq.com/s/K2ufHtGKP5YeNDYarg7Kcw

[2] Akeso's PD-1/VEGF Bispecific Antibody Combined with Chemotherapy for First-Line Treatment of Advanced NSCLC: Updated Excellent Phase II Data Published | ASCO2023. Retrieved Jun 6, 2023. From https://mp.weixin.qq.com/s/Of3DFF_20bdnzj0IZc2ckg

[3]FibroGen Announces Positive Results from Pivotal Phase 3 Trial of Roxadustat in China for the Treatment of Anemia Induced by Chemotherapy. Retrieved May 18，2023, from https://www.fibrogen.cn/press-release-05182023/

[4]Voluntary Announcement: Acceptance of Marketing Application for Yinquanbu Tablets. Retrieved Aug 15，2023, from https://pdf.dfcfw.com/pdf/H2_AN202308151594760460_1.pdf?1692130204000.pdf

[5]Luye Pharma's Rotigotine Microspheres Marketing Application in China Accepted and Granted Priority Review. Retrieved Aug 1, 2023, from https://www.prnasia.com/story/413489-1.shtml

[6]Clear Vision, No Fluid Accumulation | Novartis' Innovative Ophthalmic Drug Brolucizumab Administered First Injection in the Guangdong-Hong Kong-Macao Greater Bay Area, Bringing New Hope to Patients with Fundus Diseases. Retrieved Mar 28, 2022, from https://mp.weixin.qq.com/s/LbtuRZoAdDyXZTNweVxsxg

[7] Qilu Pharmaceutical's PD-1/CTLA-4 Combination Antibody New Drug QL1706 Phase I Clinical Study Results Published in International Authoritative Journal. Retrieved May 10, 2023 from https://mp.weixin.qq.com/s/IJLmlNH1-QUBS6QX0Lp-yw

[8] Simcere Announcement -- New Indication Marketing Application for Cosela® (Trilaciclib Hydrochloride for Injection) Accepted by the National Medical Products Administration. Retrieved Aug 14, 2023. Fromhttp://www.cninfo.com.cn/new/disclosure/detail?stockCode=02096&announcementId=1217532516&orgId=nssc1000210&announcementTime=2023-08-14

[9] Janssen Marks First Approval Worldwide for TECVAYLI®▼(teclistamab) with EC Authorisation of First-in-Class Bispecific Antibody for the Treatment of Patients with Multiple Myeloma. Retrieved August 24, 2022, from https://www.businesswire.com/news/home/20220822005274/en

[10] Tirzepatide Injection for Long-term Weight Management in Adults Submitted for Registration in China. Retrieved Aug 21, 2023 from https://mp.weixin.qq.com/s/HzcMNcPfoxObN1_HBkQ_cA

[11]Hengrui Pharma's Innovative Drug, PARP Inhibitor Fluzoparib, New Indication Marketing Application Accepted. Retrieved Aug 22, 2023, from https://mp.weixin.qq.com/s/4hsnIM2Fva5KuDt-_2Qh-w

[12]First China-produced Novel Drug IL-12/IL-23 Monoclonal Antibody Submitted for Market Approval! Akeso's Erobacumab NDA Accepted by NMPA. Retrieved Aug 24, 2023, from https://mp.weixin.qq.com/s/wKPc_lzOfRp-wzyRrmQNtA

[13] Announcement on the Acceptance of the Marketing Authorization Application for a New Indication of Injectable Triptorelin Acetate Microspheres. Retrieved Aug 25, 2023. From http://www.cninfo.com.cn/new/disclosure/detail?stockCode=000513&announcementId=1217633851&orgId=gssz0000513&announcementTime=2023-08-25

[14] Hengrui Pharma's Innovative Drug, JAK1 Inhibitor SHR0302, Ankylosing Spondylitis Indication Marketing Application Accepted. Retrieved Aug 25，2023. From https://mp.weixin.qq.com/s/3b_F5BXdBxoOn7x2l8gMFQ

[15] Junshi Biosciences Voluntarily Discloses the Announcement of the Acceptance of the New Drug Application for Senaparib in First-Line Maintenance Treatment for the Full Population with Advanced Ovarian Cancer. Retrieved Aug 25, 2023. From http://www.cninfo.com.cn/new/disclosure/detail?stockCode=688180&announcementId=1217654725&orgId=gfbj0833330&announcementTime=2023-08-26

[16] BeOne Medicines Achieves Strong Q2 2023 Performance Growth, Accelerating Global Expansion. Retrieved Aug 2, 2023. From https://mp.weixin.qq.com/s/cXsKIw7coVFJgmXGg0t3Mw

[17] Interim Results Announcement for the Six Months Ended June 30, 2023. Retrieved Aug 29，2023. From https://pdf.dfcfw.com/pdf/H2_AN202308291596599227_1.pdf?1693310623000.pdf

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XZenith Biopharm in researchCDK4/6 InhibitorsPiroxicam