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Recently, the National Medical Products Administration passed the priority review and approval procedure and approved the import registration application of Stuximab (English name: Siltuximab for Injection) for injection of rare disease drugs urgently needed in clinical use for human immunodeficiency virus (HIV) Adult patients with multicentric Castleman disease (MCD) who are negative and human herpesvirus type 8 (HHV-8) negative
.
Public information shows that MCD is a rare disease characterized by the growth of lymphoid tissue.
Most patients have multiple organ damage and have a poor prognosis, and some patients will transform into malignant lymphoma
.
Stuximab for injection is a human-mouse chimeric monoclonal antibody, which can block the binding of human interleukin-6 (IL-6) to IL-6 receptor and inhibit IL-6.
, And then inhibit cell growth
.
The industry believes that the launch of the drug is expected to benefit a large number of patients
.
It is understood that, in fact, rare diseases have always been characterized by a small number of patients, low market demand, and high research and development costs
.
In China, the number of patients with rare diseases has exceeded 20 million, and there are more than 200,000 new patients every year
.
However, unlike the ever-increasing demand for patients, most rare diseases still lack effective treatments
.
In order to overcome the dilemma of “no medicines available” for patients with rare diseases, China has attached great importance to the diagnosis, treatment and research and development of rare diseases in recent years, and has continuously issued rare disease catalogs, rare disease diagnosis and treatment guidelines, priority review and approval, and inclusion of rare disease drugs in medical insurance.
Policies and measures such as the scope and scope, continue to accelerate the R&D and innovation of rare disease drugs, as well as the review and approval procedures for the marketing and import of drugs
.
For example, in May 2018, the National Medical Products Administration and the National Health Commission issued the "Announcement on Optimizing Drug Registration Review and Approval Matters"
.
It is proposed that for the prevention and treatment of serious life-threatening diseases and rare disease drugs that have been marketed abroad and there is no effective treatment method, the import drug registration applicant can submit the clinical trial data obtained overseas and directly apply for the drug listing registration if the applicant for the registration of imported drugs believes that there is no ethnic difference.
Apply
.
In addition, for the above-mentioned clinical trial applications for imported drugs that have been accepted and submitted for exemption of clinical trials before the issuance of the "Announcement" and meet the requirements of the "Administrative Measures for Drug Registration" and related documents, they can be directly approved for import
.
On February 11, 2021, the State Council held an executive meeting, which also revealed key information about rare disease drugs
.
The meeting pointed out that strengthening the prevention and treatment of major diseases such as cancer and rare diseases has a bearing on the well-being of hundreds of millions of people
.
More than 20 million patients with rare diseases should be guaranteed medication
.
Starting from March 1, for the first batch of 21 rare disease drugs and 4 APIs, with reference to anti-cancer drugs, a 3% reduction in value-added tax will be levied on the import link, and the domestic link can choose to levy a value-added tax based on the 3% simple method
.
On October 11, the Drug Evaluation Center of the State Food and Drug Administration also officially issued a notice on the public solicitation of the "Guiding Principles for the Clinical Research and Development of Rare Disease Drugs", aimed at further improving the efficiency of clinical research and development of rare diseases and satisfying the treatment of patients with rare diseases.
Demand, combined with the characteristics of rare diseases, provide suggestions and references for the development of rare disease drugs and scientific trial design
.
Judging from a series of favorable policies, the industry believes that in the future, in addition to domestic pharmaceutical companies that will accelerate the development of rare disease drugs, the rate of imported rare disease drugs entering the country is expected to continue to increase, further increasing Chinese patients’ exposure to imported rare disease drugs.
Accessibility
.
.
Public information shows that MCD is a rare disease characterized by the growth of lymphoid tissue.
Most patients have multiple organ damage and have a poor prognosis, and some patients will transform into malignant lymphoma
.
Stuximab for injection is a human-mouse chimeric monoclonal antibody, which can block the binding of human interleukin-6 (IL-6) to IL-6 receptor and inhibit IL-6.
, And then inhibit cell growth
.
The industry believes that the launch of the drug is expected to benefit a large number of patients
.
It is understood that, in fact, rare diseases have always been characterized by a small number of patients, low market demand, and high research and development costs
.
In China, the number of patients with rare diseases has exceeded 20 million, and there are more than 200,000 new patients every year
.
However, unlike the ever-increasing demand for patients, most rare diseases still lack effective treatments
.
In order to overcome the dilemma of “no medicines available” for patients with rare diseases, China has attached great importance to the diagnosis, treatment and research and development of rare diseases in recent years, and has continuously issued rare disease catalogs, rare disease diagnosis and treatment guidelines, priority review and approval, and inclusion of rare disease drugs in medical insurance.
Policies and measures such as the scope and scope, continue to accelerate the R&D and innovation of rare disease drugs, as well as the review and approval procedures for the marketing and import of drugs
.
For example, in May 2018, the National Medical Products Administration and the National Health Commission issued the "Announcement on Optimizing Drug Registration Review and Approval Matters"
.
It is proposed that for the prevention and treatment of serious life-threatening diseases and rare disease drugs that have been marketed abroad and there is no effective treatment method, the import drug registration applicant can submit the clinical trial data obtained overseas and directly apply for the drug listing registration if the applicant for the registration of imported drugs believes that there is no ethnic difference.
Apply
.
In addition, for the above-mentioned clinical trial applications for imported drugs that have been accepted and submitted for exemption of clinical trials before the issuance of the "Announcement" and meet the requirements of the "Administrative Measures for Drug Registration" and related documents, they can be directly approved for import
.
On February 11, 2021, the State Council held an executive meeting, which also revealed key information about rare disease drugs
.
The meeting pointed out that strengthening the prevention and treatment of major diseases such as cancer and rare diseases has a bearing on the well-being of hundreds of millions of people
.
More than 20 million patients with rare diseases should be guaranteed medication
.
Starting from March 1, for the first batch of 21 rare disease drugs and 4 APIs, with reference to anti-cancer drugs, a 3% reduction in value-added tax will be levied on the import link, and the domestic link can choose to levy a value-added tax based on the 3% simple method
.
On October 11, the Drug Evaluation Center of the State Food and Drug Administration also officially issued a notice on the public solicitation of the "Guiding Principles for the Clinical Research and Development of Rare Disease Drugs", aimed at further improving the efficiency of clinical research and development of rare diseases and satisfying the treatment of patients with rare diseases.
Demand, combined with the characteristics of rare diseases, provide suggestions and references for the development of rare disease drugs and scientific trial design
.
Judging from a series of favorable policies, the industry believes that in the future, in addition to domestic pharmaceutical companies that will accelerate the development of rare disease drugs, the rate of imported rare disease drugs entering the country is expected to continue to increase, further increasing Chinese patients’ exposure to imported rare disease drugs.
Accessibility
.
