This year, these 12 innovative Chinese drugs were recognized or fast-tracked by the FDA for breakthrough therapies

According to public information, as of December 17, at least 12 innovative drugs developed by Chinese companies have been approved by the FDA as breakthrough therapies or fast-tracked in 2020, from companies such as Keystone Pharmaceuticals, Rongchang Bio, and Huang Pharmaceuticals and Asahi Pharmaceuticals.
breakthrough therapy identification and fast-track qualification are important review procedures for FDA accelerated drug development and review, and are primarily applicable to innovative drugs for serious or life-threatening diseases.
these qualifications not only means the FDA's recognition of the potential of these innovative drug treatments, but also means that pharmaceutical companies have more opportunities to communicate with the FDA and accelerate the entire research and development process.
, let's take a look at what these innovative drugs are in China. What diseases are they mainly used to treat? 1, cornerstone pharmaceutical industry: Shugli monoanti (CS1001) target: PD-L1 According to the cornerstone pharmaceutical press release, Shugli monoanti is an all-human full-length anti-PD-L1 monoclonal antibody, but also a natural G-type immunoglobulin 4 (IgG4) monoantigen closest to the human body.
the risk of immunogenicity and associated toxicity in patients with Shugli monoantigens, which makes Shugli monoantigens a potentially unique advantage.
in China, Shugli's application for listing has been accepted by china's State Drug Administration (NMPA) for the first-line treatment of advanced scaly and non-squamous non-small cell lung cancer patients with combined chemotherapy.
October 2020, Keystone Pharmaceuticals announced that Shuglidan resistance had been awarded a breakthrough treatment by the FDA to treat adult relapse or refractic natural killer cell/T-cell lymphoma (ENKTL).
according to data released at the 2020 annual meeting of the Chinese Society of Clinical Oncology (CSCO), the objective remission rate was 44.7% in 38 ENKTL patients with assessable efficacy, 31.6% in full remission and 16.8 months in median remission duration (mDoR).
43 patients who received the drug, the medium total survival was 19.7 months and the one-year total survival (OS) rate was 55.5%.
2, Rongchang Biology: Vidicyto monoanti (RC48) Target: HER2 Vidisito monoantigen is an antibody drug joint targeting HER2, its molecular structure includes a new humanized HER2 antibody, connective (with lysate in tumor cells), small molecule cytotoxic 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 FDA awarded Vidicido mono-breakthrough therapy as a second-line treatment for localized late stage or metastatic urethroid cancer expressed by HER2 (IHC 2 plus or IHC 3 plus).
November 2020, Vidicyto monoantigen was approved in the United States for clinical trials for advanced or metastatic stomach cancer and adenocarcinoma in the gastroesophageal binding department, and was granted fast-track access to the treatment of stomach cancer by the FDA.
, Rongchang Bio plans to launch a clinical study in the U.S. in 2021 to treat urethroid and stomach cancers, according to public data.
in China, the listing application of Vidisito monoantigen for the treatment of gastric cancer patients has been included in the priority review, and the application of Vidicido monoantigen for patients with HER2 over-expression urethra skin cancer is intended to be included in the breakthrough treatment varieties.
3, Regenerant Biology: Terripley monoanti (JS001) Target: PD-1 Ripley monoantigen is a recombinant humanized anti-PD-1 injection monoclonal antibody.
September 2020, Regency Bio announced that the FDA had awarded Ripley a single anti-breakthrough therapy for the treatment of nasopharyngeal cancer.
press release that this is the first Chinese-made anti-PD-1 monoantial to be recognized by the FDA for breakthrough therapies.
addition, Ripley has been awarded three FDA-awarded orphan drug treatments for mucosal melanoma, nasopharyngeal cancer, and soft tissue sarcoma.
in China, Terripri monoantigen was approved for sale at the end of 2018 for the treatment of local progress or metastasis melanoma after previous standard treatments failed.
addition, Ripley Has submitted applications for the listing of new drugs for nasopharyngeal and urethra cancers in China and has been included in the priority review.
According to the official data of Junshi Bio, Since the beginning of clinical research and development in 2016, Ripley Has carried out more than 30 clinical studies around the world, covering nasopharyngeal cancer, urethra skin cancer, lung cancer, stomach cancer, esophageal cancer, liver cancer, breast cancer, kidney cancer and other adaptations.
4, Wanchun Medicine: Punabrin Target: GEF-H1 Punabrin is a neutrophilic particle in the bone marrow induced by chemotherapy drugs by reversing the neutrophils in the ostrich nucleotide exchange factor (GEF-H1) Cell blocking formation, maintaining neutral granulocyte levels within the normal range, achieves the role of early protection of white blood cells in the bone marrow, and reduces the occurrence of early neutral granulocytosis (CIN) by a mechanism different from that of G-CSF (granulocyte collection stimulation factor).
September 2020, Wanchun Pharmaceuticals announced that the FDA had awarded a breakthrough therapy for injectable Punabrin thick solution to prevent the reduction of neutral granulocytes induced by chemotherapy to non-myelin malignancies.
noted that China's State Drug Administration (NMPA) also included Punabrin-rich solutions in breakthrough therapeutic varieties in September.
, Punablin is expected to be a major breakthrough treatment in CIN for 30 years, according to an earlier press release from Wanchun Pharmaceuticals.
5, and yellow medicine: Sovantini Target: VEGFR, FGFR, CSF-1R Sovantini is a small molecule oral tyrosine kinase inhibitor, which functions by inhibiting the endothositive growth factor of blood vessels (VEGFR) and fibroblast growth factors (FGFRs) block tumor angiogenesics and inhibit the set-up stimulation factor-1-1R, which promotes the body's immune response to tumor cells by regulating tumor-related macrophages.
, because the drug has a dual mechanism of anti-tumor angiogenesy and immunomodulation, it may be ideal for use in combination with other immunotherapy.
April 2020, the FDA granted Sovantini two fast-track qualifications for the treatment of patients with advanced and incarnated pancreatic neuroendocrine tumors and non-pancreatic neuroendocrine tumors that are not suitable for surgery.
it is worth mentioning that China NMPA has accepted the application for the treatment of non-pancreatic neuroendocrine tumors and pancreatic neuroendocrine tumors, respectively.
6, Aceh Pharmaceuticals: HQP1351 (Oribatini) Target: BCR-ABL/KIT HQP1351 is an oral third-generation BCR-ABL/KIT inhibitor.
BCR-ABL kinase region mutation is one of the important mechanisms of obtainive resistance, HQP1351 has obvious 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, HQP1351 was granted FDA-granted orphan drug eligibility and fast-track eligibility to treat CML patients with specific gene mutations that failed in existing TKI treatments.
in China, NMPA has accepted the listing application for HQP1351 and included it in its priority review.
HQP1351 is expected to become the Chinese mainland third-generation BCR-ABL inhibitor to be released in the U.S., according to publicly available data.
7, Kangfang Bio: AK104 Target: PD-1/CTLA-4 AK104 is a PD-1/CTLA-4 dual-specific tumor immunotherapy drug developed by Kangfang Bio.
August 2020, AK104 was granted fast-track status by the FDA for second-line treatment for relapsed or metastatic cervical cancer.
According to an earlier press release issued by Kangfang Bio, AK104 targets two proven immunochemical checkpoint molecules PD-1 and CTLA-4 at the same time, and the drug candidate is intended to achieve priority binding to tumor-soaked lymphocytes (TIL) rather than normal exoglomerate lymphocytes.
clinical trials conducted in Australia and China, AK104 has shown clinical efficacy and good safety.
8, Rongchang Bio: Tatasip Target: BLyS/APRIL Tatasip is a new TACI-Fc fusion protein that targets two important cell signaling molecules, BLyS and APRIL, associated with B-cell-mediated autoimmune diseases.
currently, Rongchang Bio is developing Taitasipu for the treatment of systemic lupus erythematosus (SLE), rheumatoid arthritis and other autoimmune diseases.
, systemic lupus erythematosus is the main adaptive disorder of Tetasip.
April 2020, the FDA granted TateSip fast-track eligibility.
in China, NMPA received a conditional approval application for the treatment of systemic lupus in November 2019 and included it in its priority review.
In addition to SLE, Rongchang Bio is also conducting post-clinical trials in China for six other types of B-cell-mediated autoimmune diseases, covering a variety of adaptations such as optic neurospinal myelitis spectrum disease, rheumatoid arthritis, IgA nephritis (IgA nephropathy).
9, and yellow medicine: quiniteni target: VEGFR pyridinib is a small molecule angiogenesic inhibitor, the main target is VEGFR kinase family (VEGFR1, 2 and 3).
this product inhibits tumor growth by inhibiting VEGFR phosphorylation and downstream signal transduction on the surface of vascular endothor cells, as well as the proliferation, migration and tube cavity formation of endoblast cells in blood vessels.
the drug was approved in China in 2018 to treat metastatic colorectal cancer.
June 2020, pyriquine was granted fast-track status by the FDA to treat patients with metastatic colorectal cancer.
In September, he announced that it had launched a phase 3 registered study of FRESCO-2 in patients with metastatic colorectal cancer in the United States, Europe and Japan, the main endpoint of which was OS, and that patient recruitment was planned at approximately 130 research centers in 10 countries.
10, Kangfang Bio / Zhengda Tianqing: Pian puli single resistance (AK105) target: PD-1 Pianpley monoanti is a PD-1 monoantigen drug, by Kangfang Bio and China Biopharmaceuticals zhengda Tianqing set up a joint venture joint development and commercialization.
public data show that the Fc-mediated utility function of the product is completely removed by the Fc region mutation, and has the characteristics of slow antigen binding and dissocation rate.
these characteristics make Pianpre monoantion more effective in blocking the activity of the PD-1 path, and maintain stronger T-cell anti-tumor activity, potentially becoming a better clinically-advantaged anti-PD-1 drug.
October 2020, the FDA granted Pianpley single anti-fast-track eligibility to treat third-line metastatic nasopharyngeal cancer.
according to publicly available data, in a registered clinical study for third-line treatment of metastatic nasopharyngeal cancer, Pianprey single resistance reached the primary endpoint of objective remission rate (ORR) assessed by independent imaging.
in patients with nasopharyngeal cancer who have been treated with multiple lines in the past, the drug candidates have demonstrated good clinical efficacy and safety.
11, Goliath wholly owned subsidiary Ganlai Pharmaceuticals: ASC42 Target: FXR ASC42 is a new highly effective and selective nonsteroidal nonsteroidal vaniol X-subject (FXR) astigtor.
FXR is a nucleo-subject expressed in the liver and an important target for researchers to develop drugs to improve liver fat degeneration, inflammation and fibrosis.
December 2020, the FDA granted ASC42 fast-track status for the treatment of non-alcoholic fatty hepatitis (NASH).
, ASC42 is an oral tablet developed by proprietary technology, with stable characteristics at room temperature.
in clinical development, the product can be used neither alone nor in a joint use with ASC40 or ASC41, two other clinically-staged drug candidates in the GANLE Pharmaceutical NASH pipeline.
previously shown significant improvements in liver fatty degeneration, inflammation and fibrosis in two NASH animal models.
12, SOE: DB102 (enzastaurin) Target: DB102, PKC beta, PI3K, and AKT, was originally developed by Eli Lilly and Company, and Soryuan Bio now has global rights to the drug.
2020, Soryuan Bio announced that the FDA had granted DB102 fast-track eligibility for first-line treatment of cerebroglioblastoma (GBM). according to
, DB102 is a small molecule serine/suline kinase inhibitor, which is used on key tumor targets in the field of PKC beta, PI3K and AKT, has the direct effect of inducing tumor cell death and hindering tumor cell growth, and inhibits the indirect effect of tumor-induced angiogenesis, and is intended to develop treatment for primary treatment of high-risk large B cell lymphoma and cerebroglioblastoma.
, DB102's International Multi-Center Clinical Phase 3 trial for the treatment of newly diagnosed glioblastoma has been approved by FDA and NMPA and fully launched in the United States and China.
the innovative drugs developed by these Chinese companies, which will be approved by the FDA as breakthrough therapies or fast-tracked in 2020, and hope that they will be approved for early market access to benefit patients.
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