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[Pharmaceutical Network Industry News] The "Comprehensive Report on Rare Diseases" pointed out that by 2025, the global orphan drug market is expected to reach 110 billion US dollars, and the domestic market is expected to reach 30 billion yuan
.
There are many types of rare diseases, and the total number of patients is not "rare"
.
It is understood that in recent years, with the help of policies, some domestic companies have actively deployed the field of rare diseases, and capital is also helping the development of R&D companies
.
According to the "Comprehensive Report on Rare Diseases", domestic companies including Beihai Kangcheng, Shufang Pharmaceutical, Deyi Sunshine, Weisheng Pharmaceutical, Nuoling Bio, West Lake Biomedical Technology, Langyu Group, Lingyi Bio and other enterprises have received capital assistance.
.
One of the representative companies, Beihai Kangcheng, has landed on the Hong Kong Stock Exchange in December 2021 after completing multiple rounds of financing
.
In addition, Sunflower Pharmaceutical, Junshi Bio, Shanghai Pharmaceuticals, Hengrui Medicine and other listed pharmaceutical companies have also announced their layout in the field of rare disease drugs
.
For example, Sunflower Pharmaceutical has already begun to deploy the children's orphan drug market
.
Among them, on December 17, 2021, Sunflower Pharmaceutical and Dr.
Ruidi reached a strategic cooperation to introduce two rare drugs for children with rare diseases that have been approved for marketing overseas, one is the rare disease drug "Vigrenic acid" for the treatment of infantile spasms The other is the rare disease drug "Trientine Hydrochloride Capsule" for the treatment of children's Wilson's disease (Wilson's disease), also known as "copper doll disease", to help solve the shortage of drugs for children's rare diseases in China
.
Junshi Bio has also ushered in new breakthroughs in the field of orphan drugs.
Following the grant of breakthrough therapy and orphan drug designation by the U.
S.
Food and Drug Administration (FDA), on the evening of July 21 this year, Junshi Bio announced that, Its self-developed anti-PD-1 monoclonal antibody, toripalimab, for the treatment of nasopharyngeal carcinoma, has been granted orphan drug designation by the European Commission
.
So far, the indication of toripalimab for nasopharyngeal cancer has obtained the "orphan drug" designation in the world's two major developed country drug markets
.
Shanghai Pharmaceuticals is a company with many approvals for rare disease drugs in China.
Deepening the field of rare diseases is an important development strategy of Shanghai Pharmaceuticals
.
For example, in 2020, Shanghai Pharmaceuticals established a wholly-owned subsidiary, Shanghai Shanghai Pharmaceuticals Ruier Pharmaceuticals Co.
, Ltd.
, based on ensuring the supply of existing rare disease drugs, focusing on the innovative research and development, manufacturing of rare disease drugs, and the layout of the entire industry chain and specializing in rare diseases.
Promote the platform to promote the development of rare disease diagnosis and treatment in China
.
On November 11, 2021, Shanghai Pharma Realer and Kaichuan Pharmaceutical Technology Co.
, Ltd.
reached an investment merger and acquisition cooperation, and Shanghai Pharma's rare disease drug product pipeline will be stronger
.
Hengrui Medicine recently stated in its 2022 semi-annual report that Hengrui Medicine currently has a number of products involving children's drugs, rare disease drugs and other fields, and said that the company will actively communicate with regulatory agencies on drug research and development plans during the research and development process.
Exchange, improve the efficiency of clinical research and development of related drugs, and strive to enjoy the support of preferential policies such as the follow-up market exclusivity period while accelerating the solution of the unmet treatment needs of patients
.
It is reported that on June 14, 2022, Hengrui Medicine announced that the company's Haitrombopag ethanolamine tablets (thrombopoietin receptor agonist TPO-RA) for the indication of thrombocytopenia caused by chemotherapy for malignant tumors has been approved by the US Food and Drug Administration Orphan drug designation granted by the Food and Drug Administration (FDA)
.
It is understood that in the past, the field of rare diseases in China was constrained by policies and the development of the pharmaceutical industry, and many patients were in a situation where no drugs were available
.
However, with the introduction of a series of favorable national policies, the development of rare disease drugs has also attracted the attention of the industry
.
For example, on May 9, 2022, the State Drug Administration issued the "Regulations on the Implementation of the Drug Administration Law of the People's Republic of China (Draft for Comments)", proposing to grant market exclusivity for up to 7 years to new drugs for rare diseases that have been approved for marketing.
term protection
.
Article 29 stipulates: "The state encourages the development and innovation of drugs for rare diseases, supports drug marketing authorization holders to develop drugs for rare diseases, and encourages the development of new indications for rare diseases for drugs already on the market.
Rare disease drugs are given priority review and approval
.
During the drug development and registration application period, strengthen communication with sponsors, promote the accelerated marketing of rare disease drugs, and meet the clinical drug needs of patients with rare diseases
.
For new rare disease drugs approved for marketing, they will be listed in the drug market.
Under the condition that the license holder promises to guarantee the supply of drugs, a market exclusivity period of up to 7 years will be granted, during which the same varieties will not be approved for marketing
.
If the drug marketing license holder fails to fulfill the supply guarantee commitment, the market exclusivity period will be terminated
.
” National The Drug Evaluation Center of the Food and Drug Administration also issued the "Technical Guidelines for Clinical Research and Development of Drugs for Rare Diseases" in January this year.
, elaborate on the clinical research and development of rare disease drugs, encourage the use of more flexible designs, make full use of limited patient data, etc.
, and use surrogate endpoints for efficacy evaluation indicators to support the use of patient-reported outcomes and real-world research for rare diseases.
R&D
.
The industry said that with the help of favorable policies, drugs for rare diseases will be launched at an accelerated pace, and domestic companies have also begun to pay attention to the field of rare diseases, deploying research and development to win market opportunities
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
.
There are many types of rare diseases, and the total number of patients is not "rare"
.
It is understood that in recent years, with the help of policies, some domestic companies have actively deployed the field of rare diseases, and capital is also helping the development of R&D companies
.
According to the "Comprehensive Report on Rare Diseases", domestic companies including Beihai Kangcheng, Shufang Pharmaceutical, Deyi Sunshine, Weisheng Pharmaceutical, Nuoling Bio, West Lake Biomedical Technology, Langyu Group, Lingyi Bio and other enterprises have received capital assistance.
.
One of the representative companies, Beihai Kangcheng, has landed on the Hong Kong Stock Exchange in December 2021 after completing multiple rounds of financing
.
In addition, Sunflower Pharmaceutical, Junshi Bio, Shanghai Pharmaceuticals, Hengrui Medicine and other listed pharmaceutical companies have also announced their layout in the field of rare disease drugs
.
For example, Sunflower Pharmaceutical has already begun to deploy the children's orphan drug market
.
Among them, on December 17, 2021, Sunflower Pharmaceutical and Dr.
Ruidi reached a strategic cooperation to introduce two rare drugs for children with rare diseases that have been approved for marketing overseas, one is the rare disease drug "Vigrenic acid" for the treatment of infantile spasms The other is the rare disease drug "Trientine Hydrochloride Capsule" for the treatment of children's Wilson's disease (Wilson's disease), also known as "copper doll disease", to help solve the shortage of drugs for children's rare diseases in China
.
Junshi Bio has also ushered in new breakthroughs in the field of orphan drugs.
Following the grant of breakthrough therapy and orphan drug designation by the U.
S.
Food and Drug Administration (FDA), on the evening of July 21 this year, Junshi Bio announced that, Its self-developed anti-PD-1 monoclonal antibody, toripalimab, for the treatment of nasopharyngeal carcinoma, has been granted orphan drug designation by the European Commission
.
So far, the indication of toripalimab for nasopharyngeal cancer has obtained the "orphan drug" designation in the world's two major developed country drug markets
.
Shanghai Pharmaceuticals is a company with many approvals for rare disease drugs in China.
Deepening the field of rare diseases is an important development strategy of Shanghai Pharmaceuticals
.
For example, in 2020, Shanghai Pharmaceuticals established a wholly-owned subsidiary, Shanghai Shanghai Pharmaceuticals Ruier Pharmaceuticals Co.
, Ltd.
, based on ensuring the supply of existing rare disease drugs, focusing on the innovative research and development, manufacturing of rare disease drugs, and the layout of the entire industry chain and specializing in rare diseases.
Promote the platform to promote the development of rare disease diagnosis and treatment in China
.
On November 11, 2021, Shanghai Pharma Realer and Kaichuan Pharmaceutical Technology Co.
, Ltd.
reached an investment merger and acquisition cooperation, and Shanghai Pharma's rare disease drug product pipeline will be stronger
.
Hengrui Medicine recently stated in its 2022 semi-annual report that Hengrui Medicine currently has a number of products involving children's drugs, rare disease drugs and other fields, and said that the company will actively communicate with regulatory agencies on drug research and development plans during the research and development process.
Exchange, improve the efficiency of clinical research and development of related drugs, and strive to enjoy the support of preferential policies such as the follow-up market exclusivity period while accelerating the solution of the unmet treatment needs of patients
.
It is reported that on June 14, 2022, Hengrui Medicine announced that the company's Haitrombopag ethanolamine tablets (thrombopoietin receptor agonist TPO-RA) for the indication of thrombocytopenia caused by chemotherapy for malignant tumors has been approved by the US Food and Drug Administration Orphan drug designation granted by the Food and Drug Administration (FDA)
.
It is understood that in the past, the field of rare diseases in China was constrained by policies and the development of the pharmaceutical industry, and many patients were in a situation where no drugs were available
.
However, with the introduction of a series of favorable national policies, the development of rare disease drugs has also attracted the attention of the industry
.
For example, on May 9, 2022, the State Drug Administration issued the "Regulations on the Implementation of the Drug Administration Law of the People's Republic of China (Draft for Comments)", proposing to grant market exclusivity for up to 7 years to new drugs for rare diseases that have been approved for marketing.
term protection
.
Article 29 stipulates: "The state encourages the development and innovation of drugs for rare diseases, supports drug marketing authorization holders to develop drugs for rare diseases, and encourages the development of new indications for rare diseases for drugs already on the market.
Rare disease drugs are given priority review and approval
.
During the drug development and registration application period, strengthen communication with sponsors, promote the accelerated marketing of rare disease drugs, and meet the clinical drug needs of patients with rare diseases
.
For new rare disease drugs approved for marketing, they will be listed in the drug market.
Under the condition that the license holder promises to guarantee the supply of drugs, a market exclusivity period of up to 7 years will be granted, during which the same varieties will not be approved for marketing
.
If the drug marketing license holder fails to fulfill the supply guarantee commitment, the market exclusivity period will be terminated
.
” National The Drug Evaluation Center of the Food and Drug Administration also issued the "Technical Guidelines for Clinical Research and Development of Drugs for Rare Diseases" in January this year.
, elaborate on the clinical research and development of rare disease drugs, encourage the use of more flexible designs, make full use of limited patient data, etc.
, and use surrogate endpoints for efficacy evaluation indicators to support the use of patient-reported outcomes and real-world research for rare diseases.
R&D
.
The industry said that with the help of favorable policies, drugs for rare diseases will be launched at an accelerated pace, and domestic companies have also begun to pay attention to the field of rare diseases, deploying research and development to win market opportunities
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
