CSPC, Livzon... 92 new drugs were approved for clinical use, Chia Tai Tianqing attacked 5 billion varieties, and Kelun's first mouth-dissolving film came

Highlights

The first domestic product! Hengrui's 2 class 1 new drugs were approved for marketing;

2 more new drugs approved! Blowout of Class 1 new drugs of traditional Chinese medicine;

The first domestic class 1 new anti-ED drug in China was approved for marketing;

Chia Tai Tianqing Pharmaceutical has attacked nearly 5 billion varieties;

Over 3 billion market, Kelun Pharmaceutical's first oral dissolving film reported production;

CSPC, Shandong New Era.

Haisco, Haosen.

11 new drugs are making progress! 5 domestic class 1 new drugs approved

During the period from December 25, 2021 to January 14, 2022, the marketing applications of 11 new drugs (16 acceptance numbers) were updated with review and approval status

(2021.

Hengrui Pharmaceutical's 2 Class 1 new drugs were approved for marketing

2 new TCM Class 1 drugs were approved for marketing for the first time

Yuekang Pharmaceutical's idenafil is a phosphodiesterase type 5 (PDE5) inhibitor, which increases the intracellular cGMP concentration by inhibiting the activity of PDE5 that degrades cGMP, resulting in smooth muscle relaxation and increased arterial blood flow in the cavernosus of the penis.

CSPC's mitoxantrone liposome is an improved new drug with complete intellectual property rights for relapsed or refractory peripheral T-cell lymphoma

Letermovir, approved by Merck for the first time in China, is a novel non-nucleoside CMV inhibitor (3,4-dihydroquinazoline), which blocks the processing and processing of viral DNA by inhibiting the activity of the cytomegalovirus terminal enzyme complex.

A number of new drugs and new indications have been approved for marketing

29 new drugs have been applied for listing! 3 new anti-tumor class 1 drugs are coming

From December 25, 2021 to January 14, 2022, 29 new drug (41 acceptance numbers) marketing applications were undertaken by CDE

(2021.

3 domestic anti-tumor Class 1 new drugs were declared for marketing

2 mouth-dissolving films are reported for production, and no products of the same dosage form have been approved in China

Chia Tai Tianqing Nanjing Shunxin Pharmaceutical's rituximab is a biosimilar drug, and the global sales of the original product in 2020 will reach 4.

Magituximab is an Fc-optimized monoclonal antibody that acts on HER2.

SHR8008 is a new oral azole antifungal drug introduced by Hengrui Medicine to Mycovia, which can inhibit the fungal CYP51 enzyme with high specificity.
The indication for this report is acute vulvovaginal candidiasis
.
In the field of systemic anti-infective drugs, in addition to the SHR8008 capsules that have been reported for production, Hengrui Medicine also has 4 new class 1 drugs that are in Phase I clinical trials
.
According to data from Minet.
com, the market size of terminal systemic anti-infective chemicals in China's public medical institutions will exceed 100 billion yuan in 2020
.

A number of new drug applications for new indications, including Eli Lilly's baricitinib (JAK inhibitor), Roche's vebotuzumab (anti-CD79b ADC), AbbVie's upatinib (JAK inhibitor), etc.

.

Kelun, CSPC, Shandong New Era.
.
.
92 new drugs were approved for clinical use

During the period from December 25, 2021 to January 14, 2022, 92 new drugs (136 acceptance numbers) were granted implied licenses for clinical trials
.
Among them, 68 varieties (101 acceptance numbers) are domestic new drugs, and 24 varieties (35 acceptance numbers) are imported new drugs
.
In terms of drug types, there are 52 chemical drugs, 38 therapeutic biological products, and 2 Chinese patent medicines
.
Among the 68 domestic new drugs, 52 are Category 1 new drugs
.

(2021.
12.
25-2022.
1.
14) Domestic/imported new drugs approved for clinical use

CSPC's 6 new drugs have been approved for clinical use.
Among them, the first class of new drugs, SYHX2001, is a highly selective PRMT5 inhibitor.
It has significant efficacy against acute myeloid leukemia, pancreatic cancer, melanoma and adenoid cystic carcinoma, and has good safety Sexual and pharmacokinetic characteristics
.

It is not the first time that 3 new Class 1 drugs of Kangfang Bio have been approved for clinical use
.
AK104 is a PD-1/CTLA-4 double antibody, which has been reported for cervical cancer indications; AK112 is a PD-1/VEGF bispecific antibody, and is in phase III clinical trials in China for non-squamous non-small cell lung cancer indications; AK117 is the second Generation of CD47 antibody, acute myeloid leukemia and other indications to carry out phase Ib/II clinical trials in China
.

Two new drugs from BeiGene were approved for clinical use
.
The first clinically approved BGB-16673 is the company's first protein degradation targeted chimera (PROTAC) project to enter the clinic
.

1A46 (BR110) of Enmu Bio/Borui Bio is a T cell Engager trispecific antibody targeting CD3, CD19 and CD20.
It is the world's first clinically approved CD3/CD19/CD20 trispecific antibody.
Solve the problem of drug resistance or relapse caused by target loss or downregulation of other single-targeted therapies
.
This is the first clinical approval in China, and it is intended to be used for the treatment of relapsed or refractory B-cell non-Hodgkin lymphoma
.

PH94B is a GABAA receptor modulator developed by VistaGen and introduced by Ai Mai Medical.
It has the characteristics of odorless, fast onset (within 15 minutes) and good safety.
It is the first clinically approved for the treatment of adult social anxiety disorder (SAD).
) anxiety symptoms
.

SCR-6852 (SIM0270) is a new generation of oral selective estrogen receptor (ER) degrader independently developed by Simcere Pharma.
This is the first clinical approval in China for the treatment of ER+/HER2- breast cancer
.

ZG19018 is a KRAS G12C selective covalent inhibitor independently developed by Zejing Pharma.
It is the first clinically approved for the treatment of KRAS G12C-mutated advanced malignant solid tumors
.
At present, only one drug with the same target and mechanism has been approved for marketing in the world, which is Amgen's Sotorasib (AMG510)
.
In addition, Novartis' JDQ443 and Mirati's adagrasib are progressing rapidly, both of which are in clinical phase III
.

HLX35, which was approved for clinical use in China for the first time, is a recombinant human anti-EGFR and anti-4-1BB bispecific antibody independently developed by Henlius
.
At present, no drug with the same target has been approved for marketing in the world, and the 4-1BB monoclonal antibody and double antibody under development are still in the early clinical or preclinical stage
.

Junshi Bio's JS019 is a recombinant fully human anti-CD39 monoclonal antibody that targets highly expressed CD39 in the tumor microenvironment in a highly selective manner, achieving high efficacy while reducing potential systemic side effects
.
At present, there are no more than 10 companies developing drugs with the same target worldwide, and all of them are in early clinical stage
.

AstraZeneca's MEDI3506, a monoclonal antibody that inhibits the function of interleukin-33 (IL-33), was approved for clinical use in China for the first time for the additional maintenance treatment of patients with chronic obstructive pulmonary disease
.
Phase I clinical trials have shown that MEDI3506 can effectively reduce the levels of pro-inflammatory cytokines IL-5 and IL-13 in the serum of COPD patients
.

Haisco, Haosen, Renfu.
.
.
111 new drug clinical applications were undertaken

From December 25, 2021 to January 14, 2022, clinical applications for 111 new drugs (involving 160 acceptance numbers) were accepted by CDE
.
Among them, 90 varieties (132 acceptance numbers) are domestic new drugs, and 21 varieties (28 acceptance numbers) are imported new drugs
.
In terms of drug types, there are 55 chemical drugs, 51 therapeutic biological products, and 5 Chinese patent medicines
.
Among the 90 domestic new drugs, 71 are Category 1 new drugs
.

(2021.
12.
25-2022.
1.
14) Domestic/imported new drug clinical applications undertaken

AK127, a TIGIT monoclonal antibody, which Akebio has applied for clinical application for the first time in China, has launched Phase I clinical trials overseas for the treatment of advanced or metastatic solid tumors
.
At present, there is no drug approved for TIGIT in China, but there are many companies, including BeiGene, Bio-Tech, and Junshi Biotechnology
.

Sunshine Guojian's SSGJ-617 is the first anti-PSGL-1 monoclonal antibody to be applied for clinical application in China.
This product reprograms macrophages to a pro-inflammatory state, activates T cells and attracts other immune cells to synergize to produce a strong anti-tumor effect
.
In both PD-1-responsive and non-responsive tumors, PSGL-1 antibodies demonstrated stronger inflammatory responses than current immunotherapy
.

Henlius’ HLX301 is a PD-L1/TIGIT dual antibody for the treatment of various advanced solid tumors
.
Preclinical studies have shown that HLX301 can inhibit tumor growth with good tolerance and safety
.
At present, there are other drugs under research with the same target in China, such as SH006 of Shenghe Pharmaceutical and PM1022 of Pumis
.

Lepu Bio's recombinant humanized anti-PD-L1 monoclonal antibody/human TGF-β fusion protein (LP008) is a fusion of anti-PD-L1 monoclonal antibody and the extracellular domain of human TGF-β receptor type II.
bifunctional protein
.
At present, among the drugs under research with the same target in China, only the products of Hengrui Medicine and Merck are in the clinical stage
.

Zai Lab's ZL-1211 is a CLDN18.
2 monoclonal antibody that enhances the ADCC effect through modification, and has demonstrated potent anti-tumor activity in models with high and low expression of Claudin 18.
2
.
At present, no drug with the same target has been approved for marketing in the world, but Hengrui, Cinda, BeiGene, Tianguangshi and other companies have all made arrangements
.

Tonghua Dongbao's soluble glargine lispro di-insulin (THDB0207) is the only compound preparation that can successfully combine long-acting insulin glargine and fast-acting insulin lispro
.
At present, the only dual insulin product approved in the world is Novo Nordisk's dual insulin aspart, which was approved to enter the domestic market in May 2019, and its sales in public medical institutions in China will increase in the first half of 2021.
The speed exceeds 6000%
.

AstraZeneca submitted clinical trial applications for two new Class 1 drugs on the same day
.
Oleclumab is a potential "first-in-class" anti-CD73 monoclonal antibody that selectively binds and inhibits the activity of CD73; monalizumab is a potential "first-in-class" antibody developed by AstraZeneca in collaboration with Innate.
Anti-NKG2A antibody with high specificity for human NKG2A
.
Both CD73 and NKG2A are emerging targets for tumor immunotherapy
.

CP0119 is an intestinal motility enhancer with a new target designed and developed by the Nankai University team.
By combining with transgelin protein, it promotes the aggregation of actin protein, increases the contractile function of intestinal muscle cells, and plays a role in promoting intestinal peristalsis.
It is planned to be developed for use in Treatment of chronic transit disease of the colon
.