As we wave goodbye to 2020 and embrace the arrival of 2021, it’s time for us to review, sum-up, and outlook. In recent years, more and more Chinese-produced innovative drugs have gone global and received Fast Track designations from the FDA. Receiving the fast track designations means that the new drugs have shown potential to meet unmet medical needs in early trials, and the pharmaceutical companies can have more opportunities to communicate with the FDA to speed up the entire R&D process. Then, which are the Chinese innovative oncology drugs that have granted Breakthrough Therapy designations or Fast Track designations in 2020?
Pharmaceutical product: Sintilimab
Target: PD-1
Company: Innovent
The FDA granted an Orphan Drug designation to sintilimab (TYVYT) on Apr. 14, 2020, for the treatment of esophagus cancer, which was the third Orphan Drug designation obtained by TYVYT, followed by being granted the designation for peripheral T-cell lymphoma by the EMA and the designation for T-cell lymphoma by the FDA.
As an anti-PD-1 monoclonal antibody co-developed by Innovent and Eli Lilly and Company, sintilimab was approved for marketing in China in Dec. 2018 for the treatment of relapsed/refractory classical Hodgkin's lymphoma (r/r cHL) and has been included in the National Reimbursement Drug List of China. Furthermore, two new indication applications for the products: first-line treatment for non-squamous non-small cell lung cancer (NSCLC) and first-line treatment for non-squamous NSCLC in combination with gemcitabine have been accepted by the NMPA.
Pharmaceutical product: Sugemalimab (CS1001)
Target: PD-L1
Company: CStone Pharmaceuticals
CStone Pharmaceuticals announced in Oct. 2020 that sugemalimab received a Breakthrough Therapy designation from the U.S. FDA for the treatment of adult patients with relapsed or refractory extranodal natural killer/T-cell lymphoma (ENKTL).
As a fully human, full-length anti-PD-L1 monoclonal antibody, sugemalimab mirrors the natural G-type immunoglobulin 4 (IgG4) human antibody, which may reduce the risk of immunogenicity and toxicities in patients, showing a potentially unique advantage over similar drugs. According to the data presented at the 2020 annual meeting of the Chinese Society of Clinical Oncology (CSCO), the objective response rate (ORR) of 38 evaluable patients with ENKTL was 44.7%, with a complete response (CR) rate of 31.6%; the median duration of response (mDoR) was 16.8 months. The median overall survival (mOS) of the 43 patients who received study drug treatment was 19.7 months, and the 1-year OS rate was 55.5%.
Bio pharmaceutical products: KN026
Target: HER2
Company: Alphamab
Pharmaceutical product: KN046
Target: PD-L1/CTLA-4
Company: Alphamab
Alphamab Oncology announced on Dec. 23, 2020, that the combination therapy of the bispecific antibodies KN026 (anti-HER2 bispecific antibody) and KN046 (anti-PD-L1/CTLA-4 bispecific single domain antibody) independently developed by the company received an Orphan Drug designation from the FDA for the treatment of HER2-positive or low expressing gastric or gastroesophageal junction cancer.
This is the third Orphan Drug designation granted to Alphamab. According to early trial data, the objective response rate of KN046 in combination with KN026 in HER2-positive tumors was 64.3%, and the disease control rate 92.9%. Its phase Ⅱ pivotal clinical study (SEARCH-01) is in planning. Let’s look forward to the new approach that KN046 plus KN026 will provide to address the unmet medical need in near future.
Pharmaceutical product: Disitamab vedotin (RC48)
Target: HER2
Company: RemeGen
The U.S. FDA granted a Breakthrough Therapy designation to disitamab vedotin in Sept. 2020 for the indication of second-line treatment of HER2-expressing (IHC 2+ or IHC 3+) locally advanced or metastatic urothelial cancer (UC). In Nov. 2020, disitamab vedotin received approval in the U.S. for the clinical trial of treating advanced or metastatic ...
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