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For a long time, children's medicines in our country have been faced with the problems of fewer children's special varieties, fewer suitable dosage forms, and irregular use of medicines
.
In recent years, with the release of a series of policies such as encouraging the R&D and production of children's drugs, accelerating the approval of children's drug applications, and the three-child policy, pharmaceutical companies' enthusiasm for children's drug R&D has begun to be ignited
.
Some time ago, domestic pharmaceutical companies reported good news in children's innovative drugs.
ACT001, developed by Tianjin Suntech Pharmaceutical, obtained the FDA-approved RPDD for Rare Diseases in Children
.
According to data, ACT001 is a multi-target small molecule immunomodulator developed exclusively by Accendatech worldwide.
The unique advantage of ACT001 in global immunomodulators is: it can penetrate the blood-brain barrier well and is reversible.
Open the blood-brain barrier to help other drugs increase the concentration into the brain
.
ACT001 is a multi-target small molecule immunomodulator developed exclusively by Accendatech globally.
The unique advantage of ACT001 in global immunomodulators is that it can penetrate the blood-brain barrier well and can open the blood reversibly.
The brain barrier helps other drugs increase the concentration into the brain
.
At present, based on the current progress of clinical trials, Suntech Pharmaceuticals is actively promoting three key clinical trials with the goal of listing, including the second phase of the European, American and Australian multi-center clinical trials for DIPG, and China with combined radiotherapy for the treatment of small cell lung cancer brain metastases.
Regional clinical phase III, and global multi-center clinical phase III for idiopathic pulmonary fibrosis
.
The industry believes that if everything goes well in the clinical trials and marketing of Suntech Medicine, it will bring new treatment options to children at home and abroad
.
It is worth noting that under the influence of policies, the research and development, review and approval of children's medicines in China in recent years has seen a significant increase in momentum
.
In addition to the ACT001 developed by Tianjin Suntech Pharmaceutical which has obtained the FDA-approved RPDD status of the U.
S.
Food and Drug Administration2, on August 3, Luoxin Pharmaceutical also announced that its subsidiary Shandong Yuxin had Received the "Drug Registration Certificate" for ambroxol hydrochloride spray approved and issued by the National Food and Drug Administration (NMPA)
.
This product is a 2.
4-type new medicine, which belongs to children's special medicine.
It is suitable for the thick sputum and difficulty in expectoration of children between 2-6 years old.
It will bring new treatment options for children's respiratory diseases
.
In addition to the above drugs, according to incomplete statistics, more than 10 children's drugs have been approved for marketing since 2021 alone
.
Among them, some drugs also provide better dosage forms, such as vigabatrin powder for the treatment of infantile spasms, and nitisinone capsules for the treatment of type 1 tyrosinemia
.
In addition, there are currently more than 40 new pediatric drugs in the country that are at the stage of clinical approval and above
.
In terms of dosage forms, new drugs under development are mainly granules, oral liquids, and sprays
.
However, it should be noted that although from an overall point of view, China's children's medicine market has ushered in new development opportunities
.
However, the children's drug market is far from being saturated, and the difficulty in the development of specialized drugs will still be the main challenge for the continued growth of the children's drug market in the future
.
It is understood that there is still a lack of clinical trials in the current innovation of children's drugs in China, and the high ethical requirements of children's drug clinical trials need to take into account the characteristics and affordability of the children population, and the difficulty in recruiting research subjects
.
In short, China's children's drug market is still in a situation where there are few special varieties, fewer suitable dosage forms, fewer manufacturers, and high attention from enterprises but low actual research and development enthusiasm
.
Therefore, although there have been new developments in children's medicines, the industry has also pointed out that pharmaceutical companies still need to rely on policies to continue their efforts by accelerating innovation and research and development
.
.
In recent years, with the release of a series of policies such as encouraging the R&D and production of children's drugs, accelerating the approval of children's drug applications, and the three-child policy, pharmaceutical companies' enthusiasm for children's drug R&D has begun to be ignited
.
Some time ago, domestic pharmaceutical companies reported good news in children's innovative drugs.
ACT001, developed by Tianjin Suntech Pharmaceutical, obtained the FDA-approved RPDD for Rare Diseases in Children
.
According to data, ACT001 is a multi-target small molecule immunomodulator developed exclusively by Accendatech worldwide.
The unique advantage of ACT001 in global immunomodulators is: it can penetrate the blood-brain barrier well and is reversible.
Open the blood-brain barrier to help other drugs increase the concentration into the brain
.
ACT001 is a multi-target small molecule immunomodulator developed exclusively by Accendatech globally.
The unique advantage of ACT001 in global immunomodulators is that it can penetrate the blood-brain barrier well and can open the blood reversibly.
The brain barrier helps other drugs increase the concentration into the brain
.
At present, based on the current progress of clinical trials, Suntech Pharmaceuticals is actively promoting three key clinical trials with the goal of listing, including the second phase of the European, American and Australian multi-center clinical trials for DIPG, and China with combined radiotherapy for the treatment of small cell lung cancer brain metastases.
Regional clinical phase III, and global multi-center clinical phase III for idiopathic pulmonary fibrosis
.
The industry believes that if everything goes well in the clinical trials and marketing of Suntech Medicine, it will bring new treatment options to children at home and abroad
.
It is worth noting that under the influence of policies, the research and development, review and approval of children's medicines in China in recent years has seen a significant increase in momentum
.
In addition to the ACT001 developed by Tianjin Suntech Pharmaceutical which has obtained the FDA-approved RPDD status of the U.
S.
Food and Drug Administration2, on August 3, Luoxin Pharmaceutical also announced that its subsidiary Shandong Yuxin had Received the "Drug Registration Certificate" for ambroxol hydrochloride spray approved and issued by the National Food and Drug Administration (NMPA)
.
This product is a 2.
4-type new medicine, which belongs to children's special medicine.
It is suitable for the thick sputum and difficulty in expectoration of children between 2-6 years old.
It will bring new treatment options for children's respiratory diseases
.
In addition to the above drugs, according to incomplete statistics, more than 10 children's drugs have been approved for marketing since 2021 alone
.
Among them, some drugs also provide better dosage forms, such as vigabatrin powder for the treatment of infantile spasms, and nitisinone capsules for the treatment of type 1 tyrosinemia
.
In addition, there are currently more than 40 new pediatric drugs in the country that are at the stage of clinical approval and above
.
In terms of dosage forms, new drugs under development are mainly granules, oral liquids, and sprays
.
However, it should be noted that although from an overall point of view, China's children's medicine market has ushered in new development opportunities
.
However, the children's drug market is far from being saturated, and the difficulty in the development of specialized drugs will still be the main challenge for the continued growth of the children's drug market in the future
.
It is understood that there is still a lack of clinical trials in the current innovation of children's drugs in China, and the high ethical requirements of children's drug clinical trials need to take into account the characteristics and affordability of the children population, and the difficulty in recruiting research subjects
.
In short, China's children's drug market is still in a situation where there are few special varieties, fewer suitable dosage forms, fewer manufacturers, and high attention from enterprises but low actual research and development enthusiasm
.
Therefore, although there have been new developments in children's medicines, the industry has also pointed out that pharmaceutical companies still need to rely on policies to continue their efforts by accelerating innovation and research and development
.
