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According to incomplete statistics, as of December 25, there are 23 innovative drugs approved by the State Food and Drug Administration in 2021, including 11 traditional Chinese medicines, 9 biological drugs, and 3 vaccines
There are many bright spots in the new drugs approved by the National Food and Drug Administration in 2021.
01, 11 traditional Chinese medicines
11 traditional Chinese medicinesIn recent years, the State Food and Drug Administration has fully implemented the "Opinions of the Central Committee of the Communist Party of China and the State Council on Promoting the Inheritance and Innovative Development of Traditional Chinese Medicine" and the newly revised "Administrative Measures for Drug Registration", "Registration Classification of Traditional Chinese Medicines and Requirements for Filing Documents" and a series of standards that meet the characteristics of traditional Chinese medicine.
On March 2, the National Medical Products Administration approved the Qingfei Paidu Granules of the Institute of Basic Clinical Medicine of Chinese Academy of Chinese Medical Sciences, the Huashibaidu Granules of Guangdong Yifang Pharmaceutical Co.
Qingfei Paidu Granules Huashi Baidu Granules Xuanfei Baidu Granules
Three Chinese medicines are approved for indications: Qingfei Paidu Granules are used to sense diseases caused by cold and damp epidemics, Huashi Baidu Granules are used for diseases caused by damp toxins invading the lungs, and Xuanfei Paidu Granules are used for damp toxins.
New Coronary Pneumonia Treatment
As of 2021, the State Food and Drug Administration has approved 8 new Chinese medicines on the basis of emergency approval of Qingfei Paidu Granules, Huashi Baidu Granules, and Xuanfei Baidu Granules
On September 1, Shijiazhuang Yiling Pharmaceutical Co.
Yishen Yangxin Anshen Tablets for insomnia
On September 14, Tianjin Dongfang Huakang Pharmaceutical Technology Development Co.
Seasonal allergic rhinitis with Yiqi Tongqiao pills
On November 10, Jiangsu Kangyuan Pharmaceutical Co.
Yinqiao Qingre Tablets Exogenous Wind-heat Type Common Cold
On November 26, Hunan Nanfang Sheng Pharmaceutical Co.
Xuanqijian bone tablets mild to moderate knee osteoarthritis
November 26, marketing authorization holder for Phoenix Shandong Pharmaceutical Co.
Qizhi Yishen Capsules Early Diabetic Nephropathy
On November 26, Tasly Pharmaceutical Group Co.
Kunxinning granule female menopausal syndrome
On December 16, Yili Pharmaceutical Co.
Huzhen Qingfeng Capsules Mild to Moderate Acute Gouty Arthritis
On December 16, Shijiazhuang Yiling Pharmaceutical Co.
Jieyu Chufan Capsules for mild to moderate depression
2021 is the year with the largest number of new Chinese medicines approved in the past five years, which is more than the sum of the approvals in 2017-2020; the reform of the Chinese medicine review and approval system has begun to show results
In addition to the new high number of declarations, the distribution of innovative Chinese medicines in the field of disease treatment in 2021 will also be very rich, covering the respiratory system, nervous system, digestive tract, metabolism and immune mechanism regulation drugs and other fields
Distribution of treatment areas
02, 9 biological drugs
9 biological medicines January 15, the State Drug Administration priority review by the conditional approval procedures approved KyowaKirinInc.
Company Buluosuoyou monoclonal antibody injection on the market
.
The approved indication: it is used for the treatment of X-linked hypophosphatemia (XLH) in adults and children aged 1 year and older, and is included in the "second batch of clinically urgently needed overseas new drugs"
.
The first dual target treatment of systemic lupus erythematosus
The first dual target treatment of systemic lupus erythematosus On March 12, the National Medical Products Administration passed the priority review and approval procedure and conditionally approved Rongchang Biopharmaceuticals (Yantai) Co.
, Ltd.
for the listing of the therapeutic biological product injection tytacept (trade name: Taiai)
.
Approved indications: combined with conventional treatment, it is suitable for adult patients with systemic lupus erythematosus (SLE) with high disease activity and positive autoantibodies on the basis of conventional treatment
.
The first domestically produced antibody-conjugated drug (ADC)
The first domestically produced antibody-conjugated drug (ADC) June 9, the State Drug Administration approval process by prioritizing the review of Conditional Approval Rongchang biopharmaceutical (Yantai) Co.
, Ltd.
declared injection Wei Dixi trastuzumab (trade name: love the Greek) on the market
.
The approved indication: for the treatment of patients with locally advanced or metastatic gastric cancer (including gastroesophageal junction adenocarcinoma) who have received at least two types of systemic chemotherapy
.
Vidicuzumab is the third ADC drug approved in China after Roche's Kadcyla and Seagen/Takeda's Adcetris, and it is also the first ADC drug developed by a domestic pharmaceutical company
.
The first CAR-T therapy approved in China
The first CAR-T therapy approved in China On June 23, the National Medical Products Administration approved the Akilunsai injection (trade name: Yikaida) declared by Fosun Kate Biotechnology Co.
, Ltd.
through the priority review and approval procedure
.
Approved indications: for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after receiving second-line or above systemic therapy (including diffuse large B-cell lymphoma non-specific, primary mediastinal large B-cell Lymphoma, high-grade B-cell lymphoma, and diffuse large B-cell lymphoma transformed from follicular lymphoma)
.
Fosun Kate's Akilunza injection opened the prelude to domestic CAR-T therapy, and the sky-high bill of 1.
2 million injections also made the domestic medical circle boil over
.
November 25, the State Drug Administration approval process by priority review conditionally approved the fourPharmaceutical Co.
, Ltd.
declared Enwo Li monoclonal antibody injection (trade name: En Weida) listed
.
Approved indications: for the treatment of unresectable or metastatic microsatellite highly unstable (MSI-H) or mismatch repair gene defects (dMMR) in adult patients with advanced solid tumors , including past fluorouracils, oxa Patients with advanced colorectal cancer who have progressed after treatment with riplatin and irinotecan and other patients with advanced solid tumors who have progressed after previous treatment and have no satisfactory alternative treatment plan
.
The first domestic approved drug for the treatment of rare diseases (iMCD)
On December 2, the National Medical Products Administration approved the import registration application of Stuximab (English name: Siltuximabfor Injection) for injection of rare disease drugs in urgent need of clinical application through the priority review and approval procedure
.
Approved indications: for adult patients with multicentric Castleman disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpes virus type 8 (HHV-8) negative
.
my country's first approved new coronavirus neutralizing antibody combination therapy drug with independent intellectual property rights
my country's first approved new coronavirus neutralizing antibody combination therapy drug with independent intellectual property rights On December 8, the National Medical Products Administration approved Tengsheng Huachuang Medical Technology (Beijing) Co.
, Ltd.
's new coronavirus neutralizing antibody combined therapy drug Ambavirimab Injection (BRII-196) and Romisvirimab Application for registration of injection (BRII-198)
.
This is China's first approved new coronavirus neutralizing antibody combination therapy with independent intellectual property rights
.
This approved indication: It is used in combination to treat mild and common adults and adolescents (12-17 years old, weight ≥40kg) new coronavirus infection (COVID- 19) Patients
.
Among them, adolescents (12-17 years old, weight ≥40kg) are eligible for conditional approval
.
On December 21, 2021, the National Medical Products Administration approved the import registration application of Orfatumumab Injection (English name: Ofatumumab Injection) for the treatment of rare diseases through the priority review and approval procedure
.
Multiple sclerosis (MS) is an immune-mediated chronic central nervous system disease and has been included in the first batch of rare diseases in China
.
Ofatumumab injection is an anti-human CD20 fully human immunoglobulin G1 monoclonal antibody that targets CD20 molecules and achieves therapeutic effects by inducing B cell lysis
.
Approved indications: for the treatment of adult relapsing multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting multiple sclerosis and active secondary progressive multiple sclerosis
.
December 21, the State Drug Administration approved the cornerstone Pharmaceutical (Suzhou) Co.
, Ltd.
declared Shu Geli monoclonal antibody injection (trade name: Optional GMC) on the market
.
Approved indications: used in combination with pemetrexed and carboplatin in patients with metastatic non-squamous non-small cell lung cancer with negative epidermal growth factor receptor (EGFR) gene mutation and anaplastic lymphoma kinase (ALK) negative First-line treatment for patients with metastatic squamous non-small cell lung cancer combined with paclitaxel and carboplatin
.
Up to now, four PD-L1 antibodies have been marketed in China, and CStone's suglizumab is the fourth domestically approved PD-L1 antibody and the second domestically approved PD-L1 antibody
.
03, 3 vaccines
3 vaccines On February 5, 2021, the State Drug Administration has conditionally approved Beijing Kexing Zhongwei Biotechnology Co.
, Ltd.
's new coronavirus inactivated vaccine (Vero cell ) registration application
.
The approved indication: used to prevent the disease caused by the new coronavirus infection (COVID-19)
.
February 25, 2021, the State Drug Administration conditionally approved the China National Pharmaceutical Group Biological Wuhan Institute of Biological Products Co.
, Ltd.
of novel coronavirus inactivated vaccine (Vero cells) application for registration
.
The approved indication: used to prevent the disease (COVID-19) caused by the new coronavirus infection
.
The first approved domestic adenovirus vector new coronavirus vaccine
The first approved domestic adenovirus vector new coronavirus vaccine On February 25, CanSino Bio's recombinant new coronavirus vaccine (type 5 adenovirus vector) was approved for marketing
.
This vaccine is the first domestically-made adenovirus vector new coronavirus vaccine, which is suitable for preventing diseases caused by new coronavirus infection (COVID-19)
.
On February 25, 2021, the National Medical Products Administration approved the registration application for the recombinant new coronavirus vaccine (type 5 adenovirus vector) of Cansino Biotech Co.
, Ltd.
with conditions
.
This vaccine is the first domestic adenovirus vector new coronavirus vaccine approved
.
.
The approved indication: used to prevent the disease (COVID-19) caused by the new coronavirus infection
.
