Hansoh Pharma
Pharmaceutical Research, Production, and Sales
Introduction | INTRODUCTION
This issue's highlights continue to compile the significant approval events of targeted drugs in the solid tumor field over the past month.
EGFR/KRAS/BRAF
NMPA | Nanjing Sanhome Pharmaceutical's Third-Generation EGFR TKI Approved for New Indication, First-Line Treatment of NSCLC
Recently, Nanjing Sanhome Pharmaceutical Co.,Ltd. submittedRipretinib Mesylate Tablets(Nanjing Sanhome Pharmaceutical Co.,Ltd.®) The new indication marketing application has been approved for first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring sensitive mutations of the epidermal growth factor receptor (EGFR). This product was approved in June for use in patients who have experienced disease progression during or after prior EGFR-TKI treatment and have been confirmed by testing to haveEGFRTreatment of adult patients with locally advanced or metastatic NSCLC who are T790M mutation-positive. In addition, the product is used for adjuvant treatment in postoperative stages II-IIIB.EGFRResearch on NSCLC patients with mutations is also underway.
NMPA | Aosaikang's Third-Generation EGFR TKI New Indication Submitted for Marketing, First-Line Treatment for NSCLC
In August, Aosaikang Pharmaceutical submittedLiotinib Tablets(ASK120067) New indication application for marketing approval has been accepted, first-line treatment forEGFRAdult patients with locally advanced or metastatic NSCLC with 19Del or L858R mutations. Aosaikang has also previously filed for the treatment of patients who experienced disease progression during or after prior EGFR TKI treatment and were confirmed by testing to haveEGFRT790M mutation positive, or primaryEGFR Second-line treatment for adult patients with locally advanced or metastatic NSCLC who are T790M mutation-positive.
NMPA | Hansoh Pharma's Third-Generation EGFR-TKI Fourth Indication Proposed for Priority Review for the Treatment of NSCLC
In August, Hansoh Pharma submittedAlmonertinib Mesylate Tablets(Ameile®) The new indication marketing application is proposed to be included as a breakthrough therapy and given priority review for the treatment of unresectable locally advanced disease without progression after platinum-based radical chemoradiotherapy.EGFRPatients with NSCLC harboring 19Del or L858R mutations. Previously, this drug was approved for second-line and first-line indications in NSCLC.EGFRThe indication for adjuvant treatment of NSCLC patients with 19Del or L858R mutations after surgery has also been recently accepted.
NMPA | Teligene/Suzhong Pharma EGFR TKI Proposed for Breakthrough Therapy Designation, TargetingEGFR Non-classical mutation
In July, jointly applied by JIANGSU SUZHONG PHARMA GROUP CO., LTD. and othersSunitinib Malate CapsulesProposed to be included in the breakthrough therapy category, for locally advanced or metastatic NSCLC (limited to non-resistant rare types). EGFRMutations, including L861Q, G719X and/or S768I). This drug is mainly used to treat non-resistant EGFRNon-classical mutations, or resistance developed after first-line treatment with third-generation EGFR inhibitorsEGFRLocally advanced or metastatic NSCLC with non-classical mutations.
NMPA | Innovent/Great Wisdom Pharmaceuticals KRAS Inhibitor Approved for Marketing, for NSCLC
In August, Innovent Biologics submittedFluzelacet Tablets(IBI351) has been approved for marketing to treat patients who have received at least one systemic therapy.KRAS G12C mutant advanced NSCLC. IBI351 is not only the first KRAS inhibitor approved in China, but also the first domestically produced KRAS inhibitor to be approved globally. The other two marketed KRASG12C inhibitors are respectively Amgen'sSotorasib(Sotorasib) and Bristol-Myers Squibb'sAdagrasib(Adagrasib) has entered the Phase III clinical stage for the treatment of NSCLC in China.
NMPA | Pierre Fabre's BRAF Inhibitor Submitted for Marketing Approval in China, for the Treatment of Colorectal Cancer
Recently, Pierre Fabre submittedEncorafenib Capsules（encorafenib，Braftovi®) has been accepted for marketing application, for use inBRAFV600E Mutant Colorectal Cancer (CRC). This product is an oral small molecule BRAF kinase inhibitor, which has been approved in the United States and the European Union for indications such as melanoma, colorectal cancer, and NSCLC. Among these, the FDA approvalEncorafenib Combined with CetuximabLater-line treatment for mutant CRC, and combination with binimetinib for mutant metastatic NSCLC.
FDA | Janssen’s EGFR/c-Met Bispecific Antibody Combined with EGFR-TKI Therapy Approved for First-Line Treatment of NSCLC
In August, the FDA approved the application submitted by Johnson & Johnson.Amivantamab（Amivantamab，RYBREVANT®) andLanzenitinib Mesylate(Lazertinib, LAZCLUZE™) combination therapy regimen for first-line treatmentEGFRAdult patients with locally advanced or metastatic NSCLC with 19Del or L858R mutations.
FDA | Lepu Biopharma's EGFR ADC Granted Breakthrough Therapy Designation, Set to Submit for Marketing Approval in China
In August, LePu BioMRG003 Awarded Breakthrough Therapy Designation by the FDA for the treatment of recurrent/metastatic nasopharyngeal carcinoma. MRG003 is an antibody-drug conjugate (ADC) targeting the epidermal growth factor receptor (EGFR). MRG003 has previously been granted Breakthrough Therapy status by the CDE, as well as Orphan Drug and Fast Track designations by the FDA, and is about to be submitted for marketing approval in China.
HER2
NMPA | Daiichi Sankyo/AstraZeneca HER2 ADC Approved for the 3rd Indication in China, Treating Gastric Cancer
In August, Daiichi Sankyo submittedTrastuzumab Deruxtecan(Trastuzumab Deruxtecan, Enhertu)®) The new indication for marketing application has been approved for third-line treatment of HER2-positive adult patients with gastric or gastroesophageal junction adenocarcinoma. The drug was approved in China last year, and the first two indications are: treatment of unresectable or metastatic...HER2 PositiveAdult patients with breast cancer who have previously received one or more anti-HER2 drug treatments; unresectable or metastaticHER2 Low ExpressionAdult patients with breast cancer who have previously received at least one systemic therapy at the metastatic disease stage, or relapsed during adjuvant chemotherapy or within 6 months after completing adjuvant chemotherapy.
NMPA | Hengrui HER2 ADC Proposed for Priority Review, for NSCLC Treatment
In September, Hengrui HER2 ADC Innovative DrugRecombinant Trastuzumab Injection(SHR-A1811) is proposed to be included in the priority review, for use in locally advanced or metastatic cases that have previously received at least one systemic treatment. HER2 Treatment of mutated adult NSCLC patients. Currently, three HER2 ADCs have been approved in China, and the only domestically produced one is from Rongchang Bio.Disitamab Vedotin, In addition, Kelun Pharmaceuticals'Boduzumab(A166) has also submitted an application for market launch.
NMPA | Boehringer Ingelheim's Oral HER2 Small Molecule Inhibitor Proposed for Breakthrough Therapy Designation, for the Treatment of NSCLC
In August, Boehringer Ingelheim submittedzongertinib(BI 1810631) has been proposed for inclusion in the breakthrough therapy designation, intended for the treatment of adult patients with HER2-positive advanced, unresectable, or metastatic NSCLC who have previously received systemic therapy. The drug has been granted Fast Track designation by the U.S. FDA.
NMPA | Roche's HER2 Small Molecule Inhibitor Proposed for Inclusion in Breakthrough Therapy Designation, Targeting Brain Metastases in Breast Cancer
Recently, Zanrong Pharmaceutical submittedZN-A-1041Enteric-coated capsules are proposed to be included in the breakthrough therapy category, combined with capecitabine and trastuzumab for HER2-positive advanced breast cancer patients with brain metastases who have previously progressed after trastuzumab-containing treatment. The drug exhibits high blood-brain barrier permeability, potentially useful for treating HER2-positive breast cancer patients with brain metastases and preventing the occurrence of brain metastases.
Immunotherapy
NMPA | AstraZeneca's PD-L1 Monoclonal Antibody Fourth Indication Submitted for Marketing Approval, Treating Ovarian Cancer
In August, AstraZeneca submitted in ChinaDurvalumab Injection(Imfinzi®) has submitted a new indication application for market approval, in combination with olaparib, bevacizumab, and platinum-based chemotherapy, for the treatment of newly diagnosed advanced high-grade epithelial ovarian cancer patients (without tumor BRCA mutation). The drug has already been approved for three indications, respectively for the treatment of stage III NSCLC, extensive-stage small cell lung cancer (ES-SCLC), and locally advanced or metastatic biliary tract cancer patients. Additionally, the FDA recently approvedDurvalumab Combined with ChemotherapyUsed for nothing EGFRMutation orALK Perioperative treatment (neoadjuvant chemotherapy in combination before surgery, adjuvant monotherapy after surgery) for adult patients with resectable early-stage NSCLC (IIA-IIIB); the application for a new indication of this drug for limited-stage small cell lung cancer (LS-SCLC) has also been accepted.
NMPA | Roche's PD-L1 Monoclonal Antibody Subcutaneous Injection Submitted for Marketing Approval
July,Roche Atezolizumab InjectionThe marketing application for Tecentriq SC (subcutaneous injection) has been accepted by the CDE. Tecentriq SC is Roche's fourth approved subcutaneous anti-tumor therapy. After its submission and approval, the indications will also apply to all previously approved indications for the intravenous formulation, covering lung cancer, bladder cancer, breast cancer, and liver cancer.
NMPA | Subcutaneous Injection of PD-L1 Monoclonal Antibody Submitted by Alphamab Oncology and 3D Medicines Proposed for Inclusion in Breakthrough Therapy Designation
In August, the recombinant humanized PD-L1 single-domain antibody Fc fusion protein injection jointly submitted by Alphamab Oncology and 3D Medicines Inc.Envorliumab(Envada®) Proposed for Inclusion in Breakthrough Therapy Designation for Unresectable or Metastatic Solid Tumors with High Tumor Mutation Burden (TMB-H) That Have Failed Prior Standard Treatments and Lack Satisfactory Alternative Therapies. The drug has already been approved in China for the treatment of adult patients with advanced unresectable or metastatic solid tumors characterized by high microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR).
NMPA | China Resources Tianqing's PD-L1 + Anlotinib New Indication Submitted for Marketing Approval, for the Treatment of Renal Cell Carcinoma
In August, Zhengdatianqing reportedBeimusu Monoclonal Antibody Injection(Andewei®）Anlotinib Hydrochloride CapsulesThe new indication marketing application is for the first-line treatment of advanced unresectable or metastatic renal cell carcinoma. Previously, Bermosumab has been approved in China for the first-line treatment of small cell lung cancer. This newly submitted indication also marks the first use of a dual combination of innovative drugs produced in China for first-line immunotherapy in advanced renal cell carcinoma.
NMPA | Akeso PD-1/VEGF Bispecific Antibody Second Indication Proposed for Priority Review, First-Line Treatment for NSCLC
In August, Akeso Biopharma submittedIvokibantNew indication marketing application is proposed to be included in the priority review, as monotherapy for first-line treatment of PD-L1 positive (TPS≥1%) patients with negative EGFR gene mutations. ALK Negative locally advanced or metastatic NSCLC. The drug was approved in May.Pemetrexed and Carboplatin in CombinationFor second-line treatment of patients with locally advanced or metastatic non-squamous NSCLC who are positive for EGFR gene mutations and have progressed after EGFR-TKI therapy.
NMPA | Junshi Biosciences' PD-1 Monoclonal Antibody 12th Indication Submitted for Marketing Approval, Treating Melanoma
In August, Junshi Biosciences submittedToripalimab Injection(Topjeet)®) has been accepted for a new indication application, for first-line treatment of unresectable or metastatic melanoma. If approved, it is expected to become the first-line immunotherapy for advanced melanoma in China. Additionally, the drug submitted a marketing application for liver cancer indication in July this year, intended for first-line treatment of patients with unresectable or metastatic hepatocellular carcinoma (HCC).
NMPA | Merck's PD-1 Monoclonal Antibody New Indication Submitted for Marketing Approval, Treating Pleural Mesothelioma
Recently, MSD submittedPembrolizumab(Keytruda®) The new indication marketing application has been accepted, for use in combination with chemotherapy to treat unresectable, advanced, or recurrent malignant pleural mesothelioma. Previously, pembrolizumab had already been approved for 14 indications in China.
FDA | GSK's PD-1 Monoclonal Antibody Approved for New Indication, Targeting Endometrial Cancer
In August, GlaxoSmithKline (GSK)DostarlimabFDA Approves New Indication: In Combination with Carboplatin and Paclitaxel, Followed by Dostarlimab as a Single Agent for Adult Patients with Primary Advanced or Recurrent Endometrial Cancer. Previously, Dostarlimab was approved in combination with chemotherapy for adult patients with dMMR or MSI-H primary advanced or recurrent endometrial cancer.
FDA | Bristol-Myers Squibb’s O+Y Combination Therapy Submits New Indication, First-Line Treatment for Liver Cancer
In August, Bristol-Myers Squibb (BMS) announced that the U.S. FDA had acceptedNivolumab Combined with IpilimumabNew Indication Marketing Application for First-Line Treatment of Unresectable Hepatocellular Carcinoma (HCC). Previously, BMS had submitted a first-line hepatocellular carcinoma indication in Japan, Europe, and China.
EMA | CStone Pharmaceuticals' PD-L1 Monoclonal Antibody Approved for Marketing in Europe, First-Line Treatment for NSCLC
In July, the European Commission (EC) approved CStone Pharmaceuticals'Sugemalimab Combined with PlatinumChemotherapyUsed in the absence of EGFR sensitizing mutations, or withoutALK, ROS1, RETFirst-line treatment for adult patients with metastatic NSCLC harboring genomic tumor mutations. This drug has become the world's first PD-L1 monoclonal antibody to be launched in Europe in combination with chemotherapy for the first-line treatment of both squamous and non-squamous NSCLC, and CStone Pharmaceuticals has become the first innovative biopharmaceutical company to bring a China-produced PD-L1 monoclonal antibody to the international market.
Others
NMPA | Astellas/Pfizer Receives China's First Nectin-4 ADC Approval for Urothelial Cancer Treatment
In August, Astellas submitted the Nectin-4 targeted ADCInjection of Brentuximab Vedotin(Enfortumab vedotin, Besponsa)®) has been approved for marketing to treat patients with locally advanced or metastatic urothelial carcinoma who have previously received PD-1/PD-L1 inhibitors and platinum-based chemotherapy. This drug is the world's first Nectin-4 targeted ADC to be launched, and it has already been approved in the United States, Japan, and the European Union for the treatment of urothelial carcinoma. Additionally,In combination with PD-1 antibody PembrolizumabNew Indication Application for First-Line Treatment of Adult Patients with Previously Untreated Locally Advanced or Metastatic Urothelial Carcinoma Accepted by CDE.
NMPA | Pfizer's VEGFR Multi-Target Inhibitor New Indication Submitted for Marketing Approval, First-Line Treatment for Renal Cell Carcinoma
In August, Pfizer filedAxitinib(Inlyta®) New indication marketing application accepted for frontline treatment of metastatic renal cell carcinoma (RCC) patients. This medication is an orally administered, potent, and highly selective tyrosine kinase inhibitor (TKI) targeting vascular endothelial growth factor receptors (VEGFR) 1, 2, and 3. It was previously approved for adult patients with advanced RCC who failed prior treatment with a TKI or cytokine therapy.
NMPA | Kelun Botai TROP2 ADC New Indication Submitted for Marketing, Treating NSCLC
In August, Kelun Biotech submitted TROP2 ADCLukang Satuzumab(sac-TMT, Jiatailai®) The second indication for marketing application, used to treat locally advanced or metastatic cases that have failed EGFR-TKI and platinum-based chemotherapy.EGFR Patients with NSCLC mutations. The application has been granted priority review by the CDE.
NMPA | Virogin Biotech's Oncolytic Virus New Drug Proposed for Inclusion in Breakthrough Therapy Designation, Targeting Advanced Liver Cancer
In August, the recombinant human IL12/15-PDL1B herpes simplex type I oncolytic virus injection (Vero cells) applied by Fornova Biologics was proposed to be included in the breakthrough therapy category for advanced hepatocellular carcinoma (HCC) that has failed standard treatment.VG161Multiple clinical studies are ongoing in China, with indications including hepatocellular carcinoma, gastric cancer, intrahepatic cholangiocarcinoma, and soft tissue sarcoma, among others.
FDA | World's First TCR-T Cell Therapy Approved for Marketing, Treating Synovial Sarcoma
In August, Adaptimmune Therapeutics announced that the U.S. FDA granted accelerated approval Afamitrisgene autoleucel（TECELRA®) has been approved for marketing to treat adult patients with unresectable or metastatic synovial sarcoma who have previously received chemotherapy, are positive for HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P, and whose tumors express the MAGE-A4 antigen. This drug is not only the world's first approved solid tumor cancer T-cell therapy but also the world’s first approved TCR-T cell therapy.
FDA | Hansoh Pharma/GSK's B7-H3 ADC Granted Breakthrough Therapy Designation
In August, Hansoh Pharma announced the B7-H3-targeted ADC collaboration with GSK.HS-20093 (GSK5764227) Receives FDA Breakthrough Therapy Designation. The drug is being evaluated for the treatment of patients with (relapsed or refractory) ES-SCLC who have progressed during or after platinum-based chemotherapy.
