22 ophthalmology category 1 new drugs are coming to Hengrui, 3 new drugs are expected to be launched

Recently, new progress has been made in the research and development of new ophthalmic drugs: the first domestic VEGF/ANG-2 double antibody has been approved for clinical use, and the Class 1 new drug RA1115-B1 eye drops has been submitted for clinical application.
Domestic new ophthalmic drugs (22 category 1 new drugs) are in the stage of clinical application and above, and 3 new drugs of Hengrui are expected to be launched; in terms of generic drugs, 10 ophthalmic drugs have not been approved for the first time, and Kelun, Yangzijiang, etc.
have been deployed; 10 eye drops have been reviewed by companies, and 4 have been included in the national procurement
.
22 new ophthalmology category 1 drugs are coming, and 3 new drugs from Hengrui are on the market It is a domestic VEGF/ANG-2 double antibody approved for clinical use
.
In addition, the RA1115-B1 eye drops developed by Ruiming New Drug, the ophthalmic AAV gene therapy LX101 of Luxin Bio, and the VEGF/ANG-2 double antibody IBI324 of Innovent Bio have applied for clinical applications
.
According to data from Minet.
com, according to incomplete statistics, there are currently more than 30 new domestic ophthalmic drugs in the clinical application stage and above, of which 22 are Category 1 new drugs (including Category 1, 1.
1, 1.
5 and 1.
6, which have been listed as new drugs and new adaptations have been declared) Symptoms are not included)
.
In terms of indications, the new ophthalmic drugs under research cover dry eye, delaying the progression of myopia in children, neovascular/wet age-related macular degeneration, cataract, conjunctiva/keratitis, corneal epithelial defect repair and other sub-fields
.
Source of some new domestic ophthalmic drugs under development: Minet.
com China Drug Clinical Trial Announcement Kuhengrui Medicine's three new ophthalmic drugs have entered Phase III clinical trials, SHR8058 eye drops and SHR8028 eye drops are both introduced from Novaliq, and the former is in Phase III The main clinical endpoint of the study has been reached, and NDA will be submitted soon; HR19034 eye drops can inhibit the growth of the eye axis by interacting with the relevant receptors of the sclera, choroid, and retina, thereby delaying the progression of myopia.
At present, there is no similar product at home and abroad.
batch
.
Innovent Bio has 2 new ophthalmic category 1 drugs under development
.
IBI302 has entered Phase II clinical trials.
The new drug targets VEGF, C3b and C4b, blocks the VEGF signaling pathway and complement activation, thereby inhibiting the growth of new blood vessels in lesions, and is used for the treatment of neovascular age-related macular degeneration, etc.
; The clinical application of IBI324 is a bispecific antibody targeting angiopoietin-2 (Ang-2) and vascular endothelial growth factor (VEGF).
Currently, among the VEGF/Ang-2 dual antibodies under research in China, Roche's faricimab is injected The liquid is in Phase III clinical trials, and Osaikang's ASKG712 injection has been approved for clinical use
.
Kanghong Pharmaceutical is one of the leading ophthalmic drug companies in China, and its marketed Class 1 new drug Conbercept ophthalmic injection will be sold in China's urban public hospitals, county-level public hospitals, urban community centers and township health centers (referred to as China for short) in 2020.
Public medical institutions) terminal sales exceeded 1 billion yuan, making it the best-selling ophthalmic drug
.
Among the new ophthalmic drugs currently under development by the company, KH906 eye drops, a class 1 new drug, has entered Phase I clinical trials for the treatment of corneal neovascularization; KH737 eye drops, which have been approved for clinical use, are used to delay the progression of myopia in children
.
The three new ophthalmic drugs under development by Xingqi Eye Medicine are all Class 2 improved new drugs.
Atropine sulfate eye drops in phase III clinical trials are used to delay the progression of myopia in children, and tacrolimus eye drops in phase I clinical trials For the prevention of immune rejection after corneal transplantation, voriconazole eye drops are approved clinically for the treatment of fungal keratitis
.
According to the data of Minet.
com, the market size of tacrolimus and voriconazole in China's public medical institutions will exceed 4 billion yuan in 2020
.
10 eye drops have been reviewed by companies, Kelun, Qilu.
.
.
10 major varieties are rushing for the first imitation On February 21, Furou Pharmaceuticals/Thermo Pharmaceuticals 4 types of generic drugs sodium hyaluronate eye drops were launched The application is accepted by CDE
.
At present, domestic pharmaceutical companies have declared more than 100 ophthalmic chemical drugs (calculated by drug name + company name) under the new registration classification, of which 30 have been approved for production and are deemed to have been evaluated, involving 10 varieties (calculated by drug name)
.
Sources of ophthalmic drugs that have been reviewed by companies: Minet.
com MED2.
0 China Drug Evaluation Database Moxifloxacin Hydrochloride Eye Drops and Levofloxacin Eye Drops are highly competitive, with 8 companies that have reviewed them; Look, companies such as Yangzijiang, Xingqi ophthalmic medicine, Qilu, Wuhan Nuoan, Sichuan Heyi, Zhongshan Wanhan, Chengdu Push and other companies all have 2 or more varieties
.
Among the 10 varieties, Moxifloxacin Hydrochloride Eye Drops were included in the fifth batch of centralized procurement, two companies, China Resources Zizhu and Kelun, won the bid, and Levofloxacin Eye Drops were included in the third batch of centralized procurement.
Zhongshan Wanhan and Yangzijiang two companies won the bid.
won the bid
.
In addition, sodium hyaluronate eye drops and olopatadine hydrochloride eye drops were included in the fourth batch of centralized procurement.
The former was won by Zhenshiming, Zhongshan Wanhan, Yangzijiang and Chengdu Pushe, and the latter was won by Zhejiang Jianfeng, Two companies from Huinland won the bid
.
84 ophthalmic chemical drugs under new classification application are still under review (calculated by drug name + company name, excluding approved or disapproved/withdrawn), involving 25 varieties (calculated by drug name), of which 10 have no title yet The imitation is approved (including the first imitation of the dosage form), and varieties such as atropine sulfate eye drops, ritamilast eye drops, and difluprednate eye drops are not available in the domestic market
.
The source of the ophthalmic drugs that some companies have declared under the new classification and has not yet been approved for the first imitation: Minet.
com MED2.
0 China Drug Evaluation Database Diquafosol Sodium Eye Drops are highly competitive, and there are currently 6 companies that have reported production under the new classification In the first half of 2021, the sales of this product in China's public medical institutions exceeded 20 million yuan, an increase of 900% over the same period last year; from the perspective of enterprise declarations, Qilu, Kelun, and Tianjin Jinyao have all declared 2 or more varieties
.
In addition, domestic companies are also deploying biosimilars, including aflibercept intraocular injection solution, ranibizumab injection,
etc.
Aflibercept is a PGF/VEGFA inhibitor with global sales of more than US$8 billion in 2020.
At present, the products of Sichuan Clover and Gene Biotech have been applied for clinical trials; ranibizumab is an angiogenesis inhibitor, which will be released in 2021.
Global sales exceeded 3 billion US dollars, and the products of Shanghai United Cell, Sino-US Huadong and other companies are in Phase III clinical trials
.
According to data from Minet.
com, the terminal ophthalmic drug market in China's public medical institutions will exceed 10 billion yuan in 2020, and the sales growth rate in the first half of 2021 will be close to 30%
.
2021H1 China's public medical institutions chemical drug terminal ophthalmic drug TOP10 product source: Minet.
China's public medical institution terminal competition landscape TOP10 products, sodium hyaluronate eye drops, levofloxacin eye drops have been included in the centralized procurement, of which levofloxacin eye drops The ranking dropped from the fifth place in 2020 to the seventh place in the first half of 2021; ranibizumab injection and aflibercept intraocular injection solution have already deployed biosimilar drugs; praprofen eye drops, Consistency evaluation of the layout of a number of companies such as polyvinyl alcohol eye drops (declared in a new category)
.
In the future, as more and more new products are approved and more varieties are included in centralized procurement, the market pattern of ophthalmic drugs will face a new round of reshuffle
.