Innovative drugs approved by NMPA in 2021
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Innovative drugs approved by NMPA in 2021
Innovative drugs approved by NMPA in 2021
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 medicines, and 3 vaccines.
New drugs were approved by China National Medical Products Administration (NMPA) in 2021, there are many bright spots, not only a substantial increase in the number than in previous years, more variety of heavyweight drugs frequently appeared; from the point of view of therapeutic areas, the highest this year approved a new drug treatment field distribution It is also very rich in drugs for diseases such as tumor, respiratory system, nervous system, digestive tract, metabolism and immune system. In addition to anti-tumor drugs, it also includes new drugs for systemic lupus erythematosus, rare diseases and other diseases.
11 traditional Chinese medicines
In recent years, the State 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 on Drug Registration”, “Classification of Traditional Chinese Medicine Registration and Requirements for Application Materials” and a series of standards that meet the characteristics of traditional Chinese medicine.
Regulations and related technical guidelines have been issued and implemented one after another, fully respecting the law of traditional Chinese medicine development, encouraging traditional Chinese medicine inheritance and innovation, and maximizing and releasing the vitality and potential of traditional Chinese medicine innovation.
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., Ltd. , and Shandong Buchang Pharmaceutical Co., Ltd. through special approval procedures. the Xuanfei Baidu granule on the market.
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.
A disease caused by the lungs. The launch of Qingfei Paidu Granules, Huashi Baidu Granules, and Xuanfei Baidu Granules provides more options for the treatment of COVID-19 pneumonia .
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, Huashibaidu Granules, and Xuanfeibaidu Granules.
On September 1, Shijiazhuang Yiling Pharmaceutical Co., Ltd.’s Yishen Yangxin Anshen tablets were approved. It can be used for the treatment of insomnia with TCM syndrome differentiation of heart-blood deficiency and insufficient kidney essence.
On September 14, Tianjin Dongfang Huakang Pharmaceutical Technology Development Co., Ltd.’s Yiqi Tongqiao Pill was approved. It can be used to treat seasonal allergic rhinitis with syndrome differentiation of lung and spleen Qi.
On November 10, Jiangsu Kangyuan Pharmaceutical Co., Ltd.’s Yinqiao Qingre tablets were approved. It can be used for the treatment of exogenous wind-heat type common cold .
On November 26, Hunan Nanfang Sheng Pharmaceutical Co., Ltd.’s Xuanqijian Bone Tablet was approved. It can be used to treat mild to moderate knee osteoarthritis in traditional Chinese medicine, which is a syndrome of stasis of tendons and veins.
On November 26, the Qizhi Yishen Capsule of Shandong Phoenix Pharmaceutical Co., Ltd. was approved by the holder of the drug marketing license . It can be used for the treatment of Qi and Yin deficiency syndromes in early diabetic nephropathy .
On November 26, Tasly Pharmaceutical Group Co., Ltd.’s Kunxinning granules were approved. It can be used for the treatment of female menopausal syndrome in traditional Chinese medicine, which is a syndrome of deficiency of both kidney yin and yang.
On December 16 , Yili Pharmaceutical Co., Ltd.’s Huzhen Qingfeng Capsule was approved. It can be used for the treatment of mild to moderate acute gouty arthritis in traditional Chinese medicine where the syndrome of damp-heat accumulates.
On December 16 , Shijiazhuang Yiling Pharmaceutical Co., Ltd.’s Jieyu Chufan capsule was approved. It can be used for the treatment of TCM syndrome differentiation of mild to moderate depression, which is Qi stagnation and phlegm obstruction, and internal disturbance of depression and fire.
2021 is the year with the most 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 medicine drugs in the treatment of diseases in 2021 will also be very rich, covering the respiratory system, nervous system, digestive tract, metabolism and immune mechanism regulation drugs and other fields.
9 biological medicines
On January 15, the National Medical Products Administration approved KyowaKirin Inc.’s Brosoyuumab injection with conditions through the priority review and approval procedure .
This 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
On March 12, the National Medical Products Administration passed the priority review and approval procedure and conditionally approved Rongchang Biopharmaceuticals (Yantai) Co., Ltd. to declare the therapeutic biological product injectable tytaxep (trade name: Taiai) to be listed.
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 Chinese produced antibody-conjugated drug (ADC)
On June 9th, the National Medical Products Administration passed the priority review and approval procedure and conditionally approved the listing of vedicitumumab for injection (trade name: Aidixi ) declared by Rongchang Biopharmaceutical (Yantai) Co., Ltd.
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 Chinese pharmaceutical company.
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 Chinese CAR-T therapy, and the sky-high bill of 1.2 million injections also made the Chinese medical circle boil over.
On November 25, the National Medical Products Administration passed the priority review and approval procedure and conditionally approved the listing of envolimab injection (trade name: Envida) declared by Sichuan Silu Kangrui Pharmaceutical Co., Ltd.
Approved indications: for the treatment of adult patients with advanced solid tumors with unresectable or metastatic microsatellite highly unstable (MSI-H) or mismatch repair gene defects (dMMR) , including past fluorouracil, 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 Chinese 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 .
The approved indication: for adult patients with multicentric Castleman disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpes virus type 8 (HHV-8) negative.
China 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 COVID-19 virus 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 drug 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.
The approved indication: for the treatment of adult relapsing multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting multiple sclerosis and active secondary progressive multiple sclerosis.
On December 21, the State Drug Administration approved the listing of Shuglizumab injection (trade name: Zejiemei ) declared by CStone Pharmaceuticals (Suzhou) Co., Ltd.
Approved indications: used in combination with pemetrexed and carboplatin in patients with metastatic non-squamous non-small cell lung cancer who are negative for 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. CStone’s suglizumab is the fourth Chineseally approved PD-L1 antibody and the second Chineseally approved PD-L1 antibody.
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).
On February 25, 2021, the National Medical Products Administration has conditionally approved the registration application of the new coronavirus inactivated vaccine (Vero cell) of Sinopharm China National Biotech Wuhan Institute of Biological Products Co., Ltd.
The approved indication: used to prevent the disease (COVID-19) caused by the new coronavirus infection.
The first approved Chinese 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 Chineseally-made adenovirus vector new coronavirus vaccine, which is suitable for the prevention of 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 Chinese adenovirus vector new coronavirus vaccine approved.
The approved indication: used to prevent the disease (COVID-19) caused by the new coronavirus infection.
Innovative drugs approved by NMPA in 2021
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