Record High: Nearly 70 New Drugs Granted 'Breakthrough Therapy' Designation in China, with ADCs Leading Among Biologics
Biokin
Pharmaceutical R&D Developer
Hengrui Pharma
Innovative and High-Quality Pharmaceutical Developer
Kelun-Biotech
Innovative Drug Developer
DualityBio
Innovative Molecular Type Drug Developer
Teruisi
R&D and Manufacturer of Monoclonal Antibody Drugs for Cancer Treatment
RemeGen
Biological New Drug Developer
Innovent
High-end Biologics Developer
AbbVie
Innovative Drug Developer
Mabwell
Innovative Biopharmaceutical Company
GSK
Pharmaceutical R&D Manufacturer
MediLink
Antibody-Drug Conjugates Developer
Hansoh Pharma
Innovative Therapeutic Drug Developer
According to the Insight database, since the beginning of this year (As of November 20), with 76 clinical applications (Statistics by acceptance number, excluding proposed drugs) was officially included in the breakthrough therapy category by CDE,Involving 69 drugs, a recordSince the launch of the breakthrough therapy programAll-Time High!
Data Source: CDE Official Website,Insight Database. Statistics as of: November 20, 2024Among them:The largest number of drugs produced in China，Accounting for 75% (There is52 Products), imported drugs are available.17 Payment；In terms of drug types, there are 39 biologics, more than chemical drugs (30).In terms of indications, anti-tumor drugs are the most common, with 45 types accounting for 65%.
In terms of component categories: in biologics,Antibody-drug conjugates (ADCs) have the highest number, with 14 products., 12 of which are from domestic companies.; Followed by 12 monoclonal antibody drugs; there are 6 cell and gene therapies (CGT).
Data Source: CDE Official Website,Insight Database. Statistics as of: November 20, 2024
This article will focus on ADCs that have been officially included in the breakthrough treatment category this year, and examine which targets they address.Which indications does it point to?
Biokin BL-B01D1
EGFR×HER3 Bispecific ADC
Biokin BL-B01D1 This YearIncluded in Breakthrough Therapy Designation Four Times, The indications are:
Previously treated with PD-1/PD-L1 monoclonal antibody and received at least two lines of chemotherapy (At Least One Line Containing Platinum) Treatment failure in recurrent or metastaticNasopharyngeal Carcinoma；
Locally advanced or metastatic EGFR-sensitive mutations that have failed EGFR-TKI treatmentNon-squamous NSCLC；
Previously treated with anti-PD-1/PD-L1 monoclonal antibodies and failed platinum-based chemotherapy, locally advanced or metastaticEGFR Wild-Type NSCLC；
Previously treated with PD-1/PD-L1 monoclonal antibody combined with platinum-based chemotherapy for recurrent or metastatic diseasePatients with Esophageal Squamous Cell Carcinoma。
Screenshot from:CDE Official Website
Hengrui Pharma SHR-A1811
HER2 ADC
Since the beginning of this year, Hengrui's SHR-A1811 (Trastuzumab Deruxtecan) has had two applications included in the breakthrough therapy designation, targeting the following indications:
Previously failed at least one line of anti-HER2 treatmentHER2-positive advanced gastric cancer or gastroesophageal junction adenocarcinomaPatient;
Previously received one or more treatment regimensHER2-Positive Unresectable or Metastatic Biliary Tract CancerPatient.
Screenshot from:CDE Official Website
Currently,SHR-A1811 has been granted six Breakthrough Therapy designationsIndications cover HER2-low recurrent or metastatic breast cancer, HER2-positive recurrent or metastatic breast cancer, HER2-mutant advanced non-small cell lung cancer, HER2-positive colorectal cancer, HER2-positive advanced gastric cancer or gastroesophageal junction adenocarcinoma, and HER2-positive unresectable or metastatic biliary tract cancer.
SHR-A1811 submitted its first NDA in September this year for the second-line treatment of adult patients with locally advanced or metastatic HER2-mutant NSCLC.Is the first domestically produced HER2 ADC to apply for NSCLC indication in China.。
Kelun-Biotech SKB264
TROP2 ADC
In March this year, SKB264 was granted another Breakthrough Therapy designation for the treatment of patients with locally advanced, recurrent, or metastatic disease who are not candidates for surgical resection and have not received prior systemic therapy.PD-L1 Negative Triple-Negative Breast Cancer Patients。
Screenshot from:CDE Official Website
Lukang Satuzumab (SKB264) is a TROP2 ADC co-developed by Merck and Kelun-Biotech.This is the fourth time it has been included in the breakthrough therapy designation, with the previous three applications targeting indications related to triple-negative breast cancer, EGFR-mutant NSCLC, and HR+/HER2- breast cancer.
Lukang SatuzumabThree NDAs have been filed in China for: locally advanced or metastaticThird-line Treatment for Triple-Negative Breast Cancer, ThroughFailure of EGFR-TKI and platinum-based chemotherapyLocally Advanced or MetastaticEGFR Mutation NSCLC,ViaEGFR-TKI Treatment FailureLocally Advanced or MetastaticAdult patients with EGFR-mutated NSCLC.
DualityBio DB-1303
HER2 ADC
In March this year, DB-1303 was granted Breakthrough Therapy designation for the treatment of advanced, recurrent, or metastatic cases that have progressed during or after prior immune checkpoint inhibitor therapy.HER2-Expressing Endometrial Cancer。
Screenshot from:CDE Official Website
In the endometrial cancer field, no HER2 ADC has been approved globally.DB-1303 is in the first tier of progress for the endometrial cancer indication.A Phase III clinical trial for second-line treatment of HER2-expressing endometrial cancer is currently underway.
In April 2023, BioNTech and DualityBio reached a collaboration agreement worth over $1.67 billion, granting BioNTech exclusive rights to DB-1303 and another ADC, DB-1311, outside of Greater China. Overseas, DB-1311 (BNT323) has been granted Breakthrough Therapy Designation and Fast Track status by the FDA.
Zhejiang Teruisi Pharmaceutical Inc. TRS005
CD20 ADC
In March this year, TRS005 was included in the breakthrough therapy designation for the treatment of relapsed or refractory patients who have undergone at least two standard treatments.CD20-Positive Diffuse Large B-Cell Lymphoma。
Screenshot from:CDE Official Website
TRS005 is a CD20 ADC independently developed by Zhejiang Teruisi Pharmaceutical Inc., intended for the treatment of CD20-positive non-Hodgkin lymphoma. Existing clinical trial data show that TRS005 has demonstrated therapeutic potential in terms of safety and efficacy (including ORR, PFS, etc.).
Insight database shows,No CD20 ADC has been approved globally.. Currently, there are two CD20 ADCs that have entered the clinical stage (Only count active projects), respectively from Zhejiang Teruisi Pharmaceutical Inc. (TRS005) and Escugen (MRG001).
RemeGen "Disitamab Vedotin"
HER2 ADC
In May this year, an application for Disitamab Vedotin was included in the breakthrough therapy designation, with the indication being perioperative treatment in combination with Toripalimab Injection.HER2 expression existsAnd planning to undergo radical cystectomyMuscle-invasive Bladder Cancer。This is the third time that Disitamab Vedotin has been included in the breakthrough therapy program. Previously, its applications for treating HER2-overexpressing locally advanced or metastatic urothelial carcinoma patients and HER2-positive advanced breast cancer patients with liver metastases have been incorporated.
Screenshot from:CDE Official Website
Disitamab Vedotin is the first China-produced HER2 ADC approved in China, and has been approved for the treatment of gastric cancer and urothelial carcinoma. In October this year, Disitamab Vedotin submitted its third indication for marketing approval, which was included in the priority review for the treatment ofHER2-positive patients with advanced breast cancer and liver metastases。
Innovent Bio IBI343
CLDN-18.2 ADC
In May this year, IBI343 was included in the breakthrough therapy, indicated for patients who have received at least two systemic treatments.CLDN 18.2 Positive Advanced Gastric/Gastroesophageal Junction Adenocarcinoma。
Screenshot from:CDE Official Website
In subjects with high CLDN18.2 expression, the 6 mg/kg dose group (N=30）ofORR was 36.7%, DCR was 93.3%, 8 mg/kg dose group (N=17）ofORR was 47.1%, DCR was 88.2%；
With a median follow-up of 7.2 months, patients with high CLDN18.2 expression in the 6 mg/kg dose groupMedian PFS was 6.8 months。
Hengrui Pharma SHR-A1921
TROP2 ADC
In May this year, SHR-A1921 was included in the breakthrough therapy for the treatment of platinum-resistant recurrence.Epithelial Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal CancerCurrently, SHR-A1921 is undergoing Phase III clinical trials for ovarian epithelial cancer in China.The First TROP2 ADC to Enter Phase III Clinical Trials for This Indication。
Screenshot from:CDE Official Website
At this year's ESMO Congress, Hengrui Pharma presented the Phase I results of the first-in-human trial of SHR-A1921 for platinum-resistant ovarian cancer in an oral report for the first time. The data showed,The ORR of patients was 42.3%, the DCR was 100%, the mDoR was 9.9 months, the mPFS was 7.9 months, the median OS was not reached, and the 6-month OS rate was 91.9%.。
AbbVie Telisotuzumab Vedotin
c-Met ADC
In June this year, AbbVie's Telisotuzumab Vedotin (Teliso-V) was included in the breakthrough therapy designation for the treatment of patients who experienced disease progression during or after platinum-based therapy.Patients with c-Met protein high expression advanced/metastatic EGFR wild-type non-squamous NSCLC。
Screenshot from:CDE Official Website
Teliso-V is the c-Met ADC with the fastest global research progress, and a Biologics License Application (BLA) was submitted to the U.S. FDA in September this year. The c-Met protein is overexpressed in approximately 25% of non-squamous EGFR wild-type NSCLC patients, and there are currently no approved targeted anticancer therapies specifically for such patients.If approved, Teliso-V will become the first therapy for the c-Met overexpressed NSCLC population.。
Mabwell 9MW2821
Nectin-4 ADC
In August this year, 9MW2821 was included in the breakthrough therapy designation for the treatment of patients with locally advanced or metastatic disease who have failed prior platinum-based chemotherapy and PD-(L)1 inhibitor treatment.Patients with urothelial carcinoma。
Screenshot from:CDE Official Website
9MW2821 is the second fastest-progressing Nectin-4 ADC globally, following Astellas' Enfortumab Vedotin.The First China-produced Nectin-4 ADC to Enter Phase III Clinical Trials9MW2821 is currently undergoing three Phase III clinical trials in China, with indications including urothelial carcinoma (third-line), urothelial carcinoma (first-line), and cervical cancer (second- and third-line).
GSK Belantamab Mafodotin
BCMA ADC
In September this year, Belantamab mafodotin was included in the breakthrough therapy, combined with bortezomib and dexamethasone for the treatment of patients who have received at least one prior therapy.Adult patients with multiple myeloma。This indication has also been granted priority review by the CDE.。
Screenshot from:CDE Official Website
At this year's ASCO conference, GSK announced the data from the Phase III clinical trial DREAMM-7. The experimental group was Belantamab mafodotin + Bortezomib + Dexamethasone, and the control group was Daratumumab + Bortezomib + Dexamethasone.
Data show,The median PFS in the experimental group was 36.6 months.(vs 13.4 months)，ORR was 82.7%(vs 71.3%); compared with the control group, the experimental groupReduced the risk of disease progression or death by 59%`, and showed a clinically meaningful trend in overall survival rate,`Reduced the risk of death by 43%。
MediLink YL201
B7-H3 ADC
In October this year, YL201 was officially included in the breakthrough therapy designation for the treatment of patients who failed initial platinum-based therapy.Recurrent Small Cell Lung Cancer。
Screenshot from:CDE Official Website
At this year's ESMO Congress, MediLink disclosed the Phase I clinical data of YL201 for the first time. Among them, the extensive-stage small cell lung cancer (ES-SCLC) cohort included 72 evaluable patients, all of whom had previously received platinum-based chemotherapy, and 95% had undergone anti-PD-(L)1 therapy.The ORR of patients was 68.1%, and the mPFS was 6.2 months.In patients with brain metastases, the efficacy of YL201 was comparable to that of the overall population.ORR was 52.2%, mPFS was 5.3 months。
Hansoh Pharma HS-20093
B7-H3 ADC
In October this year, HS-20093 was officially included in the breakthrough therapy designation for the treatment of patients who have progressed after standard first-line therapy.Extensive-Stage Small Cell Lung CancerIn August this year, the indication of HS-20093 has been granted Breakthrough Therapy Designation by the FDA, and the overseas rights of HS-20093 are owned by GSK.Currently, HS-20093 is undergoing a Phase III clinical trial in China for recurrent SCLC.。
Screenshot from:CDE Official Website
At this year's WCLC, the Phase Ⅰ study of HS-20093 in the treatment of SCLC was selected as a Late-Breaking Abstract (LBA). In 53 evaluable patients:
8.0 mg/kg Dose GroupThe ORR was 61.3%, the DCR was 80.6%, the mDoR was 6.4 months, the mPFS was 5.9 months, and the mOS was 9.8 months.
10.0 mg/kg Dose GroupThe ORR was 50.0%, the DCR was 95.5%, the mDoR was 8.9 months, the mPFS was 7.3 months, and the mOS was not reached.
At doses of 8.0 and 10.0 mg/kg, patients who had previously received IO + platinum-based drugs but had not been treated with a topoisomerase I inhibitor.ORR were 75.0% and 66.7%, respectively.。
Escugen ESG401
TROP2 ADC
In November this year, ESG401 was officially included in the Breakthrough Therapy designation for the treatment of patients with locally advanced, recurrent, or metastatic disease who have not received prior systemic therapy and are ineligible for surgery.PD-L1 Negative Triple-Negative Breast Cancer。
Screenshot from:CDE Official Website
At this year's ESMO Congress, the interim results of ESG401 as a first-line treatment for patients with metastatic triple-negative breast cancer were announced. As of August 15, 2024, among 25 evaluable participants, 2 achieved complete response (CR), and 20 patients were assessed as partial response (PR).ORR reached 88%, DCR was 100%Among 3 patients with brain metastases, 2 patients achieved complete response of intracranial metastatic lesions, and 1 patient achieved partial response.The intracranial disease control rate also reached 100%.。
Image Source: CDE"2023 Annual Drug Evaluation Report"
Although the CDE has not yet announced the total number of applications for 2024, data as of November 20 shows that 76 applications have been officially included, surpassing the total for the entire year of 2023 and setting a new historical record.
Image Source:Insight Database Report
