2021 Some new drugs for tumor treatment in China

2021 Some new drugs for tumor treatment in China. China National Medical Products Administration (NMPA) approved 13 new tumor-targeting/immune drugs, including atilizumab, ametinib, enmetrastuzumab, zebutinib, etc. in 2020.  In 2021, what blockbuster new drugs in the oncology field will hopefully be approved in China?

The first precision therapy for gastrointestinal stromal tumors

• Drug: Apotinib (Ayvakyt)
• Disease area: gastrointestinal stromal tumor
• Enterprise: Blueprint Medicines, CStone Pharmaceuticals

Apatinib (avapritinib) is a highly specific KIT and PDGFRA mutant kinase inhibitor developed by Blueprint Medicines for the treatment of gastrointestinal stromal tumors with PDGFRA exon 18 mutations (including PDGFRA D842V mutations). In early 2020, avapritinib was approved by the U.S. FDA and is the first precise targeted drug for gastrointestinal stromal tumors marketed in the United States. According to the data published by Blueprint Medicines in The Lancet Oncology: Apotinib (avapritinib) is used in patients with PDGFRA D842V mutant advanced gastrointestinal stromal tumor, and the 24-month overall survival (OS) rate reached 81% , And well tolerated.

CStone Pharmaceuticals has the exclusive development and commercialization authorization of the drug in Greater China. In April 2020, CStone Pharmaceuticals submitted a marketing application for avapritinib to the National Medical Products Administration. It is currently in the first round of issuance and is expected to be approved in 2021Q4.

Be included in the national list of urgently needed overseas new drugs

• Drug: Gerritinib (Xospata)
• Disease area: acute myeloid leukemia
• Enterprise: Astellas, Japan Life Pharmaceutical Company

Gilteritinib is a new generation FLT3 tyrosine kinase inhibitor jointly developed by Astellas and Japan Life Pharmaceutical Company, which is used to treat patients with relapsed or refractory acute myelogenous leukemia who carry FLT3 gene mutations.

Gilteritinib was approved for marketing in Japan in September 2018, and was approved in the United States in November of the same year. It became the first FLT3 inhibitor approved by the FDA for relapsed and refractory AML. Approved for listing in Europe in December.

In April 2020, gilteritinib submitted a marketing application in China for the treatment of relapsed or refractory AML with FLT3 mutations. At present, the technical review of the drug is completed and it is expected to be approved in 2021Q1.

It is expected to become a new cornerstone for the treatment of patients with follicular lymphoma

• Drug: Otuzumab (Gazyva)
• Disease fields: chronic lymphocytic leukemia, follicular lymphoma
• Enterprise: Roche

Obinutuzumab injection (obinutuzumab) is a new generation of anti-CD20 humanized monoclonal antibody. Its CDC is weaker than rituximab, but its ADCC is stronger, and it has better clearance of B cells in peripheral and tissues. Ability.

Otuzumab has been approved for multiple indications in the United States, including follicular lymphoma, chronic lymphocytic leukemia/small lymphocytic lymphoma, etc. In September 2020, it was approved by the US FDA as a breakthrough therapy for the treatment of lupus nephritis.

In September 2019, the drug submitted an application for the marketing of an imported new drug in China for the treatment of follicular lymphoma. It is currently in the first round of issuance and is expected to be approved in 2021Q1.

The first CAR-T product to be approved in China

• Medicine: Yescarta (Yescarta)
• Disease fields: chronic lymphocytic leukemia, follicular lymphoma
• Enterprise: Fosun Kite, KitePharma

Akirensai injection is a CD19-targeting autologous CAR-T cell therapy product introduced by Fosun Kite from Kite Pharma in the United States and authorized for local production in China. In October 2017, Achilles was the first to be approved in the United States, becoming the first CAR-T cell therapy approved by the FDA for the treatment of adult relapsed and refractory large B-cell lymphoma. It was approved for marketing in Europe in August 2018 for the treatment of relapsed or refractory DLBCL and PMBCL.

On February 21, 2020, the listing application of Fosun Kate Achilles Injection (NMPA) was accepted, and it has entered the administrative approval stage and is expected to be approved in the near future.

The first three-generation BCR-ABL inhibitor in China

• Drug: olverembatinib
• Disease area: chronic myelogenous leukemia
• Enterprise: Yasheng Pharmaceutical

Oribatinib is an oral third-generation BCR-ABL/KIT inhibitor developed by Yasheng Pharmaceutical. It has obvious effects on BCR-ABL and its various mutants (including the T315I mutation) and is intended to be developed for treatment Patients with chronic myelogenous leukemia (CML) who are resistant to the first and second generation tyrosine kinase inhibitors (TKI). It is China’s first BCR-ABL/KIT inhibitor that is resistant to chronic myeloid leukemia.

In May 2020, auribatinib has successively obtained the orphan drug qualification and the fast-track qualification granted by the US FDA for the treatment of CML patients with specific gene mutations that have failed the existing TKI treatment. In September of the same year, Oribatinib submitted a listing application in China, which is currently under review and is expected to be approved in 2021 Q4.

The first FDA approved drug for the treatment of high-risk neuroblastoma

• Drug: Dituximab (Qarziba)
• Disease area: Neuroblastoma
• Company: BeiGene EUSA Pharma

Dituximab (dinutuximab beta) is a GD2 targeting monoclonal antibody introduced by BeiGene from EUSA Pharma for the treatment of high-risk neuroblastoma ≥12 months of age.

According to the analysis of a key phase 3 clinical study named APN311-302, compared with the control group, the survival time of the treated patients has been improved, the three-year overall survival (OS) rate has increased by 12%, and the five-year OS rate is about 65% (vs 50%).

Dituximab was first approved in the United States in March 2015. It was the first drug approved by the FDA to treat high-risk neuroblastoma in children, and it was approved for marketing in Europe in August of the same year. In November 2020, Dituximab submitted a listing application in China, which is currently under review and is expected to be approved in Q3 2021.

The first melanoma drug approved by the FDA in the past decade

• Drug: Ipilimumab (Yervoy)
• Disease area: unresectable or metastatic melanoma
• Enterprise: Bristol-Myers Squibb

Ipilimumab is an IgG1 type targeting CTLA-4 monoclonal antibody, which was first approved in the United States in March 2011 for the treatment of unresectable or metastatic melanoma. It is the first FDA-approved anti-CTLA- 4 cancer immunotherapy is also the first melanoma drug approved by the FDA in the past decade. It has strong ADCC/CDC, can selectively eliminate Treg, and then expand CD8+T cells that specifically recognize tumor antigens.

In 2019, the sales of ipilimumab was US$1.489 billion, and the first listing application was submitted in China in December of the same year. It is currently in the first round of issuance and is expected to be approved in 2021Q1.

The first Chinese lung cancer targeted innovative drug that is expected to go global

• Drug: Savoritinib
• Disease area: non-small cell lung cancer
• Enterprises: Hutchison Pharmaceuticals, AstraZeneca

Saivotinib is a potent and highly selective oral small molecule c-Met inhibitor developed by Hutchison Medicine. MET, as one of the driving genes of cancer, was discovered after targets such as EGFR, ALK, and HER2ROS1 Another target for non-small cell lung cancer, about 2-3% of patients with non-small cell lung cancer have MET exon 14 jumping mutations.

In December 2011, Hutchison Medicine and AstraZeneca signed a global patent license, cooperative development and commercialization agreement for Syvotinib. Currently, Hutchison Medicine and AstraZeneca are cooperating to carry out clinical trials of single-agent and combination therapy of Syvotinib for a variety of solid tumors worldwide. Saivotinib is expected to become the first lung cancer targeted innovative drug that represents China and goes global.

In May 2020, Syvotinib submitted a marketing application in China for the first time for the treatment of locally advanced or metastatic non-small cell lung cancer with MET exon14 jump. This is China’s first NDA application for a selective c-Met inhibitor. The technical review has been completed and it is expected to be approved in 2020 Q4.

The first approved ADC drug developped in China

• Drug: disitamab vedotin
• Disease area: advanced or metastatic gastric cancer and gastroesophageal junction cancer
• Enterprise: Rongchang Biological

Widicutumab is a new type of anti-HER2 antibody conjugate drug developed by Rongchang Biotechnology. Its molecular structure includes a new type of humanized HER2 antibody, linker (which is cleavable in tumor cells), and small molecules Cytotoxic drugs (with high toxicity and side-killing effect). As the first domestically developed ADC drug to be marketed. Vidicuzumab is used for the treatment of advanced or metastatic gastric cancer and gastroesophageal junction cancer. It has been approved by the FDA for clinical trials and granted fast-track qualifications, as well as for the second-line treatment of HER2-positive locally advanced/metastatic urothelial cancer , Was granted Fast Track and Breakthrough Therapy qualifications by the FDA.

In August 2020, Vidicuzumab submitted a marketing application for the treatment of HER2 overexpression locally advanced or metastatic gastric cancer that has received at least 2 systemic chemotherapy after recurrence or metastasis. It is currently under review and is expected to be approved in 2021Q4 .

(source:internet, reference only)

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