Recent Approvals and Clinical Advances in Oncology Targeted Therapies (Issue 14) | Key Highlights (93)

Introduction | INTRODUCTION

EGFR/ALK/KRAS

In September, Johnson & Johnson'sAmivantamab InjectionLiquid(Subcutaneous injection) marketing application in China accepted, indications may include combination with third-generation EGFR-TKI oral drugs.Lanzenitin Mesylate TabletsFor non-small cell lung cancer (NSCLC). The intravenous formulation of this drug has been approved for multiple NSCLC indications in the United States and the European Union. Recently, the drug received a new FDA approval for use in combination with standard chemotherapy to treatEGFRAdult patients with locally advanced or metastatic NSCLC harboring ex19del or L858R mutations during or after progression on EGFR-TKI treatment.

In September, LEPU BIOPHARMAVibegron Monoclonal Antibody(MRG003) Accepted for Priority Review for the Treatment of Recurrent/Metastatic Nasopharyngeal Carcinoma Patients Who Have Failed at Least Two Prior Lines of Systemic Chemotherapy and PD-1/PD-L1 Inhibitor Therapy. The drug has previously been granted Breakthrough Therapy Designation and proposed priority review status by the CDE, and it is the first domestically developed EGFR ADC to be submitted for marketing approval in China.

In October, Dizal's new lung cancer targeted drugSunvozertinib Tablets(Sunvoz)^®) has been included in the breakthrough therapy category for patients who have not received systemic treatment and carryEGFRex20ins locally advanced or metastatic NSCLC. The drug's first indication was approved in 2023 for patients who have experienced disease progression after prior platinum-based chemotherapy, or are intolerant to platinum-based chemotherapy, and have been confirmed by testing to haveEGFRPatients with locally advanced or metastatic NSCLC with ex20ins.

In September, Biokin submittedInjectable BL-B01D1Two indications are proposed to be included in the breakthrough treatment category, respectively: locally advanced or metastatic cases that have previously undergone anti-PD-1/PD-L1 monoclonal antibody treatment and failed platinum-based chemotherapy.EGFRWild-type NSCLC patients, after failure of EGFR-TKI treatmentEGFRPatients with locally advanced or metastatic non-squamous NSCLC with sensitizing mutations.

In September, Jacobio'sglecirasib(Gleciras, JAB-21822) to be included in the breakthrough therapy, combinedCetuximabUsed after failure of second-line standard treatment (including oxaliplatin, irinotecan, 5-FU, with or without anti-VEGF monoclonal antibody),KRASG12C mutation-positive patients with locally advanced or metastatic colorectal cancer that cannot be surgically removed. Additionally, the company's Pan-KRAS inhibitor JAB-23E73The tablet was also approved for clinical trials on the same day and is intended to be developed for treatment.KRAS Advanced solid tumors with genetic alterations.

In October, the Class 1 new drug of Shouyao HoldingsContetinib Granules(CT-707) submitted for marketing authorization as a single agent for the treatment of patients with locally advanced or metastatic NSCLC who are positive for anaplastic lymphoma kinase (ALK). This drug is a second-generation multi-targeted ALK kinase inhibitor, targetingALK/FAK/PTK2B/IGF1RCurrently, 11 ALK-targeted inhibitors have been approved for marketing in China.

In September, AstraZeneca's third-generation EGFR inhibitorOsimertinibApproved for a new indication, used in unresectable cases without progression after platinum-based chemoradiotherapy (CRT).EGFRMutated NSCLC adult patients.

HER2/PI3Kα/AKT

In October, the jointly developed by Daiichi Sankyo and AstraZenecaTrastuzumab Deruxtecan(Enhertu, Yuhede)^®) approved for new indications, used to treatHER2 Adult patients with unresectable or metastatic NSCLC who have activating mutations and have previously received at least one systemic therapy. The drug has previously been approved in China for three indications, targeting HER2-positive/low-expression breast cancer and HER2-positive gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. This newly approved indication marks the first coverage of NSCLC patients.

In October, Rongchang'sDisitamab Vedotin(Aidi Xi^®) The new indication application has been accepted and included in the priority review for HER2-positive advanced breast cancer patients with liver metastases who have previously received trastuzumab or its biosimilar and taxane drug treatments. This indication was previously granted Breakthrough Therapy Designation by the CDE. Two indications of Disitamab Vedotin have already been approved for marketing in China, targeting gastric cancer and urothelial carcinoma respectively, and have been included in the National Reimbursement Drug List.

In September, Hengrui Medicine's Class 1 new drug injectionRuiKang Trastuzumab(SHR-A1811) has been accepted for a new drug marketing application and has been granted priority review by the CDE for the treatment of locally advanced or metastatic diseases in patients who have previously received at least one systemic therapy.HER2Mutated adult NSCLC patients.

In October, Roche's PI3Kα inhibitor Inavolisib（Itovebi ^®) Receives FDA Approval for Market Launch, andPalbociclibAndFulvestrantCombined therapy for recurrence within 12 months after completing adjuvant endocrine treatment PI3KCAMutation HR-positive, HER2-negative advanced breast cancer.

Immunotherapy Targets

In October, BeiGene's PD-1 inhibitorTislelizumab(Tislelizumab^®) has officially received approval from China's National Medical Products Administration (NMPA), in combination withPlatinum-based chemotherapyNeoadjuvant therapy, followed by single-agent adjuvant therapy after surgery, is used for patients with resectable stage II or IIIA NSCLC. This is the first PD-1 drug approved in China for perioperative immunotherapy in both stages II and III NSCLC. Additionally, this drug is currently the PD-1 inhibitor with the most approved indications included in the National Reimbursement Drug List (NRDL).

In September, MSD's anti-PD-1 inhibitorPembrolizumab(Keytruda^®) has been approved for a new indication, as a first-line treatment for unresectable or metastatic melanoma. The drug was first approved in China in 2018 for second-line treatment of advanced melanoma. This approval further expands the treatment scope for melanoma patients to include first-line therapy.

In September, Akeso BioCadonilimab(Kaitanli^®) has been approved for a new indication in China,Combined with OxaliplatinAndCapecitabine(XELOX) is used as a first-line treatment for locally advanced recurrent or metastatic G/GEJ adenocarcinoma that is not suitable for surgical resection. In 2022, this drug became the first PD-1/CTLA-4 targeted bispecific antibody approved both in China and globally, with its initial indication targeting cervical cancer. Recently, a Phase III clinical study for the consolidation treatment of advanced NSCLC patients has been initiated in China.

In October, Bristol-Myers Squibb'sNivolumab(Opdivo^®) UnitedIpilimumab(Yiwo^®) has been approved by the NMPA for first-line treatment of patients with unresectable or metastatic high microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR) colorectal cancer. This is also the first global approval for this indication.

In September, the NMPA granted conditional approval to Qilu Pharmaceutical Co., Ltd.'s application.Aipalolitovorelimab Injection(Qi Bei An^®) has been approved for marketing in China, intended for the treatment of patients with recurrent or metastatic cervical cancer who have failed previous platinum-based chemotherapy. This is a bifunctional combination antibody, consisting of Iparomlimab, an IgG4 antibody targeting PD-1, and Tuvonralimab, an IgG1 antibody targeting CTLA-4.

October, AstraZenecaDurvalumab(Imfinzi)^®) andTislelizumab（Imjudo^®) was filed for marketing approval in China, with the speculated indication likely being the combination of the two drugs for first-line treatment of NSCLC or hepatocellular carcinoma. Currently, durvalumab has been approved for three indications in China: in combination with chemotherapy for first-line treatment of biliary tract cancer and small cell lung cancer, and as a monotherapy for maintenance/consolidation treatment of NSCLC. Regarding the CTLA4 target, ipilimumab is currently the only approved drug in China.

In September, Hengrui Medicine submitted a Class 1 new drug, an anti-PD-L1/TGF-βRII bifunctional fusion protein.Relafusp -α Injection(SHR-1701) Marketing Application Accepted, CombinedFluorouracil ClassAndPlatinum-based drugsFor first-line treatment of locally advanced unresectable, recurrent, or metastatic G/GEJ adenocarcinoma. Currently, the drug is undergoing clinical research in multiple therapeutic areas, including gastric cancer, rectal cancer, and NSCLC.

In September, the injection applied by VibeBio LBL-024 Proposed inclusion in the breakthrough therapy category for single-agent treatment of patients with advanced extrapulmonary neuroendocrine carcinoma who have progressed after receiving second-line or higher chemotherapy.

Others

In October, Johnson & Johnson'sNiraparib Abiraterone Tablets(Zebeike)^®) has been officially approved, in combination withPrednisoneOrPrednisoloneUsed for first-line treatment of patients with germline and/or somatic mutations BRCAAdult patients with metastatic castration-resistant prostate cancer (mCRPC) driven by gene mutations. As the first and only dual-action combination drug approved in China, it targets two oncogenic drivers in mCRPC patients—the androgen receptor axis andBRCA1/2Mutation.

In October, Kelun Botai declaredFor InjectionLukang Satuzumab(Sac-TMT) New Indication Marketing Application Accepted and Proposed for Priority Review, for Use After EGFR-TKI Treatment ProgressionEGFRAdult patients with mutant locally advanced or metastatic NSCLC. Previously approved indications are: for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer who have received at least two prior systemic therapies; treatment of locally advanced or metastatic disease that has failed EGFR-TKI therapy and platinum-based chemotherapy.EGFR Patients with NSCLC mutations.

In October, the small molecule tyrosine kinase inhibitor against angiogenesis developed by Zhengda TianqingAnlotinib(Fukovi)^®) The new indication marketing application has been accepted, presumably for first-line treatment of advanced unresectable or metastatic soft tissue sarcoma in combination with chemotherapy. Currently, there is no combination chemotherapy regimen approved in China for first-line treatment of such patients.

In October, Hansoh Pharma'sHS-20093 for InjectionIntended to be included in the breakthrough therapy category for extensive-stage small cell lung cancer (ES-SCLC) that has progressed after standard first-line treatment (platinum doublet chemotherapy combined with immunotherapy). The drug currently has more than ten ongoing clinical trials targeting lung cancer, sarcoma, head and neck cancer, and other solid tumors. Meanwhile, Yilian Biologics' B7-H3 ADC new drugYL201 for InjectionIntended to be included in the breakthrough therapy category for the treatment of recurrent SCLC that has failed initial platinum-based therapy.

In September, NovartisLutetium [¹⁷⁷Lu] Tesixiptide InjectionProposed for Priority Review, applicable for the treatment of PSMA-positive mCRPC in adult patients who have received androgen receptor pathway inhibitors and taxane chemotherapy.

In October, Astellas' CLDN18.2 monoclonal antibody zolbetuximab（Vyloy ^®) has been approved by the FDA for marketing and is used as a first-line treatment for adult patients with locally advanced unresectable or metastatic, CLDN-18.2-positive, HER2-negative gastric cancer or gastroesophageal junction (GEJ) adenocarcinoma.