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Summary In 2022, 21 innovative anti-tumor drugs were approved for marketing in China for the first time!

 Last Update: 2022-11-26
 Source: Internet
 Author: User

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The 2022 Chinese Society of Clinical Oncology (CSCO) was held
in Beijing during November 5-12.
According to the relevant person in charge of the Center for Drug Evaluation (CDE) of the National Medical Products Administration, as of October 2022, 21 anti-tumor innovative drugs have been approved for marketing in China for the first time, covering different cancers such as lung cancer, breast cancer, thyroid cancer, pancreatic cancer, leukemia, and lymphoma
.
Next, let's sort out these 21 approved anti-tumor drugs
for everyone.

As of October 2022, 21 innovative anti-tumor drugs have been approved for marketing in China for the first time, covering different cancers such as lung cancer, breast cancer, thyroid cancer, pancreatic cancer, leukemia, and lymphoma
.

Grand Pharmaceutical: Yttrium [90Y] microsphere injection

Indications: Colorectal cancer liver metastasis

SIR-Spheres® Yttrium [90Y] Microsphere Injection is an injection developed by Grand Pharmaceutical (China) Co.

, Ltd.
On January 30, 2022, the National Medical Products Administration (NMPA) approved the marketing application
of SIR-Spheres® yttrium [90Y] microsphere injection.
It is mainly used for inoperable resectable colorectal cancer liver metastases
that have failed standard treatment.

CStone Pharmaceuticals/Servier: Evonib tablets

Indications: Acute myeloid leukemia (AML)

Evounib (trade name Tosuvo) is the first approved potent oral targeted inhibitor
against isocitrate dehydrogenase-1 (IDH1) ® mutant cancer in China.
Originally by Agios Pharmaceuticals developed, CStone entered into an exclusive agreement with Agios in 2018 for development and commercialization in Greater China, and expanded its clinical development and commercialization licensing area from Greater China to Singapore
in 2020.

On February 9, 2022, China's National Medical Products Administration (NMPA) approved a new drug application for the first drug of its kind, ivosnib
.
The drug is the first approved IDH1 inhibitor in China for the treatment of relapsed or refractory acute myeloid leukemia (R/R) in adults carrying IDH1 susceptible mutations AML) patients
.

Henlius: Serplulimab

Indications: MSI-H solid tumor, non-small cell lung cancer

Serplulimab injection is an innovative biological drug independently developed in China - PD-1 inhibitor "Hans-like"
.
It is indicated for adult advanced solid tumors with unresectable or metastatic "microsatellite" highly unstable (MSI-H) who have failed previous standard therapy, providing a new treatment option
for domestic cancer patients.

In March 2022, serplulimab injection was approved
by the National Medical Products Administration.
In October 2022, the drug was approved for a second indication in China, combining carboplatin and albumin paclitaxel for the first-line treatment of inoperably advanced or metastatic squamous non-small cell lung cancer (NSCLC).

Takeda: Burkina tablets

Indications: Non-small cell lung cancer

Buritinib is a new ALK tyrosine kinase inhibitor, which has been clinically proven
to prolong patient survival, control brain metastasis, and improve quality of life.

Takeda China, a multinational pharmaceutical company, announced in Pudong on August 13 that its innovative drug Amberry ® (buglitinib tablets) in the field of lung cancer was officially launched
.
Burglitinib is a novel selective ALK tyrosine kinase inhibitor, which has been approved by the National Medical Products Administration (NMPA) of China in March 2022, and is suitable for the treatment of anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC), and its listing will further meet the unmet needs of ALK-positive advanced non-small cell lung cancer patients in China, and help open up a new pattern
of treatment in related fields.

Eli Lilly/Innovent Biologics: Ramoximumab

Indications: gastric cancer, hepatocellular carcinoma

In March 2022, Eli Lilly and Company) announced that Ramoxiramab has been approved in China in combination with paclitaxel for the treatment
of patients with advanced gastric or gastroesophageal junction adenocarcinoma that progresses during or after fluorouracil or platinum-based chemotherapy.
In October of the same year, the drug was approved for a new indication for
hepatocellular carcinoma in China.
Ramoximab can specifically bind to vascular endothelial growth factor receptor 2 (VEGFR-2), effectively block the binding of VEGF-A to VEGFR-2, and can also inhibit the binding
of VEGF-C and VEGF-D to VEGFR-2.

Verastem Oncology: Duvilise capsules

Indications: Follicular lymphoma (r/rFL)

On March 18, 2022, CSPC's PI3K delta / γ inhibitor "Duvelise Capsule" (former name: Duencebe) was approved for marketing for the treatment of relapsed or refractory follicular lymphoma (FL)
that has undergone at least two previous systemic treatments.
This is the first approved PI3K inhibitor
in China.
It is reported that Duvilise is made by Verastem Developed by Oncology, CSPC has exclusive rights
in China.

Pfizer: Lolatinib tablets

Indications: Non-small cell lung cancer

In April 2022, Pfizer announced that the world's first third-generation ALK inhibitor Lorbrena (generic name: lorlatinib tablets/lorlatinib).
Tablets) is approved
by the National Medical Products Administration.
Monotherapy is indicated for the treatment
of patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC).

Servier: Irinotecan hydrochloride liposomal injection

Indications: Pancreatic cancer

In April 2022, Servier's irinotecan hydrochloride liposomal injection was approved for marketing
in China.
Used in combination with 5-fluorouracil (5-FU) and folinic acid (LV) for the treatment of patients
with metastatic pancreatic cancer that has progressed after treatment with gemcitabine.

Innovent / Incyte: Pemitinib

Indications: cholangiocarcinoma

On April 6, 2022, Dabertan (Pemigatinib) was approved by the National Medical Products Administration in China for the treatment
of advanced, metastatic or unresectable cholangiocarcinoma adult patients who have received at least one prior systemic therapy and have been tested for fibroblast growth factor receptor 2 ("FGFR2") fusion or rearrangement.

Leadiant Biosciences: Procarbazine hydrochloride capsules

Indications: Hodgkin lymphoma

On April 21, 2022, Zhaoke Pharmaceutical, a subsidiary of Lee's Big Pharmaceutical, officially approved for marketing in China for the treatment
of advanced Hodgkin lymphoma.
Procarbazine hydrochloride capsules are an alkylating agent drug developed by Roche and are also a cycle non-specific antitumor drug
.
According to literature reports, the anti-tumor mechanism of action of the product is: after the drug enters the body, it is oxidized and metabolized by liver microsomes to produce methyl or other alkyl radicals, and then depolymerizes with DNA, thereby inhibiting the synthesis
of DNA, RNA and protein.

Gilead Sciences: Osatuzumab for injection

Indications: Triple-negative breast cancer

Cosartuzumab (English trade name Trodelvy, Trodavel) is indicated for use in adult patients
with unresectable locally advanced or metastatic triple-negative breast cancer who have received at least 2 systemic therapies (at least 1 of which is for metastatic disease).
In June 2022, the NMPA approved the marketing application
of Genting Xinyao's gosatuzumab (Todavel).
Gersatuzumab for injection, approval number of Sinopharm SJ20220015
.

Bayer: Larotinib sulfate

Indications: Panoma species

In June 2022, the NMPA approved Bayer Health's oral solution of lalotinib sulfate for the treatment of adult and pediatric patients with solid tumors carrying the neurotrophic tyrosine receptor kinase (NTRK) fusion gene, patients with locally advanced, metastatic disease or surgical resection that may lead to serious complications, and patients
without satisfactory treatment options.
Larotinib sulfate oral solution is the world's first oral NTRK inhibitor designed for NTRK gene fusion cancer patients, and the capsule dosage form of the drug was first approved for marketing
in China in April this year.

Akeso: Cardonilimab

Indications: Cervical cancer

On June 29, 2022, it was announced that the National Medical Products Administration of China has approved the new drug application of Kaitanib (Cardunilimab Injection), the world's first PD-1/CTLA-4 bispecific antibody tumor immunotherapy drug independently developed by Akeso, for the treatment of patients
with relapsed or metastatic cervical cancer (R/MCC) who have failed previous platinum-containing chemotherapy.

Hengrui Pharmaceutical: Revilumide tablets

Indications: Prostate cancer

Revilumide tablets generally refer to Irene
.
Arien is a new AR inhibitor with independent intellectual property rights developed by Hengrui Pharmaceutical, which was supported by the national "13th Five-Year Plan" major new drug creation science and technology major project in 2018, and was approved by the National Medical Products Administration at the end of June 2022, which is suitable for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC) with high tumor burden
.
Chinese prostate cancer patients have new treatment options
.

Lepu Bio: Putelimab

Indications: panoma, melanoma

Putelimab injection is the first innovative biological drug
developed by Lepu Biologics.
In July 2022, it was approved for listing
in China.

Putelimab injection can antagonize PD-1 signaling to restore the ability of immune cells to kill cancer cells by blocking the binding of PD-1 to its ligands PD-L1 and PD-L2, and is used to treat patients with highly unstable/mismatched microsatellite repair of defective solid tumors: patients with advanced colorectal cancer who have previously experienced disease progression after treatment with fluorouracil, oxaliplatin and irinotecan; Other patients
with advanced solid tumors who have progressed after at least first-line therapy and do not have satisfactory alternative treatment options.
In September this year, the drug was approved in China for a new indication for unresectable or metastatic melanoma
that had previously failed systemic therapy.

Roche: Entretinib capsules

Indications: Solid tumors and non-small cell lung cancers carrying NTRK fusion genes

Entrectinib is a prescription drug for the treatment of neurotrophic tyrosine receptor kinase (NTRK)-positive solid tumors and ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) adult patients in adults and children over 12 years of age
.
In July 2022, Roche announced that emtretinib was officially approved for marketing
in China.

Simcere Pharmaceutical: Traracillide for injection

Indications: Extensive stage small cell lung cancer

On July 13, 2022, Simcere Pharmaceutical (02096.
HK) and G1 Therapeutics' co-developed world's first innovative bone marrow protection drug triracillide hydrochloride for injection (trade name: Cosella) has been approved by the National Medical Products Administration (NMPA) for prophylactic administration of patients with extensive-stage small cell lung cancer (ES-SCLC) who have not previously received systemic chemotherapy when receiving platinum-containing drugs combined with etoposide regimens to reduce the incidence
of chemotherapy-induced myelosuppression.

In February 2021, triracillide hydrochloride for injection has been approved by the US FDA
.
The approved indications in China mean that this world's first "chemotherapy guard" with full bone marrow protective effect will be able to benefit the majority of Chinese patients
.

Shenzhou cells: repatumab

Indications: Diffuse large B-cell non-Hodgkin lymphoma (DLBCL)

In August 2022, Shenzhou Cell's first new anti-CD20 monoclonal antibody independently developed in China, "Anpingxi" repatumab, was approved for marketing
.
Repatumab is the cornerstone therapy for diffuse large B-cell non-Hodgkin lymphoma (DLBCL) for the treatment of newly diagnosed CD20-positive DLBCL adults
in combination with CHOP (cyclophosphamide + doxorubicin + vincristine + prednisone).

Concord Qilin: Mowglizumab injection

Indications: cutaneous T-cell lymphoma

On October 27, 2022, Xiehe Kirin announced that a targeted drug for rare diseases, mowglizumab (trade name Huierkin), has been approved
by the State Food and Drug Administration.
The drug is used to treat adult patients
with relapsed or refractory Sézary syndrome (SS) or advanced (III.
/IV.
) mycosis fungoides (MF) who have received previous systemic therapy.
Whirkin is the first and only biologics
in China approved for the treatment of SS and MF targeting CCR4.

Roche: Trastuzumab injection (subcutaneous injection)

Indications: breast cancer

On October 9, 2022, the National Medical Products Administration officially announced that it approved the marketing of trastuzumab injection (subcutaneous injection) applied by Roche (China) Investment Co.
, Ltd.
, in combination with chemotherapy for the treatment of
patients with early and metastatic HER2-positive breast cancer.

As the world's first innovative targeted drug against HER2 breast cancer, trastuzumab is the cornerstone
of HER2-positive breast cancer treatment.
Trastuzumab subcutaneous injection form revolutionizes the treatment mode of HER2-positive breast cancer, which can be administered in only 2-5 minutes, which will provide more convenient, efficient and safe personalized treatment options for breast cancer patients in China
.

Eli Lilly/Innovent Biologics: Seprutinib

Indications: lung cancer and thyroid cancer

Eli Lilly announced on October 8, 2022 that its highly selective RET inhibitor Seplitinib (40mg & 80mg capsule) approved by the National Medical Products Administration (NMPA) of China for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) positive for transfection rearrangement (RET) gene fusion, adults with advanced or metastatic RET-mutated medullary thyroid cancer (MTC) requiring systemic therapy, and children 12 years of age and older, and adults and children
aged 12 years and older with advanced or metastatic RET fusion-positive thyroid cancer (TC) who require systemic therapy and are refractory to radioactive iodine (if radioiodine is appropriate).
It is reported that Innovent Biologics has the exclusive commercialization rights
of the drug in China.

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