Anticipate the future| 21 new drugs expected to be approved for sale in China in 2021

Say goodbye to 2020 and usher in a new 2021.
expect another batch of new drugs to be approved for sale in China in the new year.
the future, this article screens 21 new drugs (in any order) that are expected to be approved for sale in 2021 for readers' reference only.
1. Drug Name: Injection Tetracip Research and Development Company: Rongchang Biopharmaceus Technology Mechanism: BLyS and APRIL Inhibitor Adaptation: Systemic Lupus (SLE) Tetracip is a bio-new drug developed by Rongchang Bio, which inhibits both BLyS and APRIL cytokines and is being developed to treat a variety of autoimmune diseases such as systemic lupus erythematosus and rheumatoid arthritis.
Based on the key clinical findings of the treatment systemic lupus erythematosus in July last year, there was a significant difference in clinical response rates between the Tetracip treatment group and the placebo control group, reaching the main endpoint, with a 48-week response rate of 79.2% in the high-dose group and 32% in the placebo control group.
also excels in safety and patient tolerance.
November 2019, china's State Drug Administration (NMPA) Drug Review Center (CDE) accepted the conditional approval of the listing application for the treatment of systemic lupus erythematosus and included it in the priority review.
addition to SLE, Rongchang Bio is also conducting post-clinical trials in China for six other types of B-cell-mediated autoimmune diseases.
2. Drug Name: Vidicyto single anti-drug research and development company: Rongchang biological drug mechanism: antibody-linked drug adaptation targeting HER2: gastric cancer, urethroid skin cancer, etc. Vidicyto monoantigen is a targeted HER2 antibody association drug, its molecular structure includes a new humanized HER2 antibody, connective (with lysis in tumor cells), small molecule cell venom drug (with high toxicity and side effects).
the drug is currently being developed for the treatment of common HER2 expression adaptations that currently lack treatment, including HER2 expression (IHC 1 plus or more) cancer adaptations other than breast cancer.
September 2020, the drug was approved by the FDA as a breakthrough therapy for second-line treatment for urethroid skin cancer.
In China, the listing application of Vidicyto monoantigen for the treatment of patients with localized advanced or metastatic stomach cancer ( including gastroesophageal adenocarcinoma) has been prioritized by CDE, and the application for HER2 over-expression of urethra skin cancer has been included in the breakthrough treatment variety by CDE.
3. Drug Name: Apotinib Tablets Research and Development Company: Keystone Pharmaceuticals/Blueprint Medicines Drug Mechanism: KIT and PDGFRA Mutation Kinase Inhibitor Adaptation: Advanced Gastrointestinal Interstitoma (GIST) Avapritinib is a highly specific KIT and PDGFRA mutation kinase inhibitor developed by Blueprint Pharmaceuticals, which is an exclusive license for the development of the drug in Greater China.
early 2020, avapritinib was approved by the FDA as the first precise target drug for gastrointestinal mesothelioma (GIST) to be marketed in the United States.
according to data published in The Lancet Oncology by Blueprint Medicines, avapritinib was used in patients with PDGFRA D842V mutant advanced gastrointestinal mesothelioma (GIST) with a 24-month total survival (OS) rate of 81% and good tolerance.
April 2020, Keystone Pharmaceuticals submitted an application to the NMPA for the listing of avapritinib, covering two adaptive disorders: (1) for the treatment of plate plateboard-derived growth factor α (PD) GFRA) exon 18 mutations (including PDGFRA D842V mutation) in adult patients with non-surgical excision or metastasis GIST, and (2) four-line non-surgical excision or metastasis GIST adult patients.
the same year, the drug's application for marketization was included in the CDE's priority review.
In addition to Apotheni tablets, keystone Pharmaceuticals developed a full-length all-human source anti-PD-L1 monoclonal antibody - Shugli monoanti (code: CS1001) of the new drug market application has also been accepted by NMPA in November 2020, for combined chemotherapy first-line treatment of patients with advanced scaly and non-scaly non-small cell lung cancer.
, the drug could also be approved in 2021, bringing new treatment options to patients.
4. Drug Name: Forthionate Vermethini Research and Development Company: Ailes Pharmaceutical Mechanism: 3 generation EGFR-TKI Adaptation: EGFR T790M mutation-positive local late stage or metastasis non-small cell lung cancer (NSCLC) Vomini is the third representative of the skin growth factor subject tyrosine kinase inhibitor (EGFR-TKI).
according to public information, as of January 29, 2020, the objective remission rate (ORR) of DFFR T790M mutation-positive patients with local late stage or metastasis NSCLC was 74.1%.
Pharmaceuticals submitted to NMPA in November 2019 an application for the conditional approval of Vermethini, a second-line treatment for non-small cell lung cancer for adaptive disorders.
the product was also included in the CDE's priority review as an "innovative drug with clear therapeutic advantages".
5. Drug Name: Sigrotea Sodium Tablets Research and Development Company: Microcore Biopharmaceutical Mechanism: PPAR Activator Adaptation: Type 2 Diabetes Sigletha Sodium is a nuclear-oxide enzyme-boosting biometric (PPAR) full-activator developed by Microcore Biology, an insulin-boosting agent for the treatment of type 2 diabetes.
previous studies, Sigletha sodium showed comprehensive improvement and good safety for clinical treatment such as insulin resistance, blood sugar, and lipid abnormalities in patients with type 2 diabetes, as well as the potential for protection of tissue organs such as islets and livers.
, according to the China Drug Clinical Trials Registration and Information Disclosure Platform, Sigleta sodium has been registered to complete at least 7 clinical trials.
Microcore Biology submitted a new drug listing application (NDA) for the treatment of type 2 diabetes in China in September 2019.
6. Drug Name: Equililonsai Injection Research and Development Company: Fosun Kate Drug Mechanism: Self-Car-T Therapy Adaptations Targeting CD19: Relapsed or Refracipitable Large B-Cell Lymphoma Iquillienser Injections (code: FKC876) is Fosun Kate introduced Yescarta technology from Gilead's company Kite Pharma in 2017 and has been authorized to localize its production in China targeting CD19's in vitro CAR-T cell therapy products.
Yescarta has been approved for listing in the US and Europe.
In China, the adaptive disorder applied for by Igililuns is an adult patient with relapsed or refractic large B-cell lymphoma after treatment of second-line or above systemic treatment, including diffuse large B-cell lymphoma (DLBCL), non-special-fingered, primary vertical B-cell lymphoma (PMBCL), high-level B-cell lymphoma, and filtered lymphoma conversion DLBCL.
the drug was included in the CDE's priority review in the first half of 2020.
7. Axa Pharmaceuticals: Arrbatini Research and Development Company: Axa Pharmaceuticals Drug Agents Adaptation: BCR-ABL/KIT Inhibitor Adaptation: Chronic Myeloid Leukemia (CML) Oribatinib (codename: HQP1351) is an oral third-generation BCR-ABL/KIT inhibitor developed by Asaan Pharmaceuticals.
BCR-ABL kinase region mutation is one of the important mechanisms of obtainive resistance, oribatinib has significant effects on BCR-ABL and its various mutants (including T315I mutation), and is intended to be developed for the treatment of patients with chronic myeloid leukemia (CML) resistant to first- and second-generation tyrosine kinase inhibitors (TKI).
May 2020, Oribatinib received FDA-granted orphan drug and fast-track eligibility to treat CML patients with specific gene mutations that failed to treat existing TKI treatments.
in China, NMPA has accepted Oribatini's listing application and included it in its priority review.
is expected to become the first third-generation BCR-ABL inhibitor to go on sale in China, according to publicly available data.
8. Drug Name: Hypoppa ethanolamine tablets Research and Development Company: Hengrui Pharmaceutical Mechanism: TPO-R astrogen adaptors: heavy-duty regenerative anemia sea curvature ethanolamine tablets are a small molecule non-peptide plate-producing protein-producing (TPO-R) agitating agent developed by Hengrui Pharmaceuticals.
According to public information, it can bind to TPO subjects on cell membranes, activate signal transducting path paths, stimulate the differentiation and proliferation of human bone marrow progenitor cells to cytonal cells, and promote the maturation of cytocytes, thereby increasing plateplate production.
Hengrui Pharmaceuticals has submitted five applications for the listing of the amine tablets in 2020 and has been accepted by CDE.
two of these cases were included in the CDE priority review in the third quarter of 2020 for the treatment of patients with severe regenerative anemia with poor immunosuppressive therapy.
9. Drug Name: Ricky Orense Injection Development Company: Drug Minxono Drug Mechanism: CAR-T Therapeutic Adaptation to CD19: Diffuse Large B Cell Lymphoma (DLBCL) Relmacabtagene autoleucel is a CAR-T therapy targeted at CD19 to be developed to treat various types of B-cell malignancies.
June 2020, the listing application for the third-line treatment of diffuse large B-cell lymphoma was accepted by NMPA and included in the priority review in September of the same year.
, according to public information, the Rekio Lunsai injection has been shown to be effective in registered clinical trials for patients who have received extensive pretreation and poor prognosis.
as of June 17, 2020, its best ORR was 75.9% and its best CRR was 51.7%.
drug Ming-Juno will also develop Ricky Orenosa injections to treat a variety of other blood-adaptive disorders, including filthoma (FL), clover lymphoma (MCL), chronic lymphoblastic leukemia (CLL), second-line DLBCL, and acute lymphoblastic leukemia (ALL).
, its application for treatment of recurring or refractic folytic folytic lymphoma was included in the breakthrough treatment variety by CDE in September 2020.
10. Drug Name: Parmipali Capsule Research and Development Company: Baiji Shenzhou Drug Mechanism: PARP Inhibitor Adaptation: BRCA Mutation of Advanced Ovarian Cancer, Fallopian Tube Cancer or Primary Peritonal Cancer Parmipali (pamiparib, BGB-290) is an independently developed PARAP1 and PARP2 inhibitors in Baiji Shenzhou with pharmacological properties such as penetrating the blood-brain barrier and PARP-DNA compound capture.
it is understood that Parmipali is currently being developed globally as a monotherapy or in combination with other drugs to treat multiple malignant solid tumors.
In July 2020, Parmipali's new drug application was approved by CDE for the treatment of patients with advanced ovarian, fallopian or primary periary cancer who have received at least two lines of chemotherapy in the past, carrying disease-causing or suspected pathogenic germ BRCA mutations.
, the listing application is included in the priority review.
is known to be based on the results of a 1/2 clinical trial of Parmipa used in the treatment of patients with advanced ovarian, fallopian tube, primary peritiotic or advanced tricystic breast cancer.
The key Phase 2 part of the trial included 113 patients in China who had received at least two standard chemotherapy sessions, high-level epithelitis cancer (including fallopian tube cancer or primary peritina cancer) with BRCA1/2 mutations, or high-level endometrial epithelitis cancer.
addition to ovarian cancer, Parmipali is conducting clinical studies on a variety of cancers, including prostate cancer, breast cancer, stomach cancer, fallopian tube cancer, primary peritometrial cancer, and more.
11. Drug Name: Ditux monoantigen research and development company: Baiji Shenzhou / EUSA Pharma Drug Mechanism: GD2 Target Monoclonal Antibody Adaptation: Dinutuximab Beta is a specific target GD2 targeted antibody introduced from EUSA Pharma, which can be combined with specific target GD2 overexpressed neuroblastoma cells.
it can induce a dual immune mechanism that allows the immune system to destroy cancer cells of neuroblastoma.
Based on a key Phase 3 clinical study called APN311-302, dinutuximab beta was used during the maintenance phase of first-line treatment of high-risk neuroblastoma, post-mortem analysis showed that the survival of patients treated (n-367) improved compared to the control group (n-367), with a 12% increase in total three-year survival (OS) and a five-year OS rate of about 65% (vs 50%).
in early November 2020, Dittoxidosis's application for the drug's listing in China was accepted by CDE, and prior to that, it had been included in the priority review for the treatment of high-risk neuromedules ≥12 months of age In patients with cytoma, these patients have previously received induced chemotherapy and received at least partial remission, followed by myelin therapy and stem cell transplantation;
12. Drug Name: Sevotinib Research and Development Company: and yellow pharmaceutical drug mechanism: small molecule MET inhibitor adaptation: MET exon 14 jump non-small cell lung cancer savolitinib is a powerful and highly selective oral small molecule MET inhibitor developed with yellow medicine.
met is one of the driving genes of cancer, and MET abnormalities are found in a variety of solid tumors.
May 2020, Sevoldini submitted the NDA in China and was accepted for the treatment of non-small cell lung cancer of the exon 14 jump of the intersupcharged endocial conversion factor (MET).
the application is based on one