In recent years, with the release and implementation of a series of favorable pharmaceutical innovation policies and the acceleration of new drug review and approval, China's new drug research and development has ushered in good development opportunities, and there are constantly good news from pharmaceutical companies in new drug research and developmen.
For example, since August, a number of pharmaceutical companies have issued announcements saying that the company's related product clinical trial applications have been accepted or entered into clinical trial.
Jianmin Pharmaceutical
Jianmin Pharmaceutical
Recently, Jianmin Pharmaceutical Group submitted a clinical application for Tongjiang Granules, which is a new type of Chinese medicine 1 dru.
It is reported that Jianmin Pharmaceutical Group exclusively acquired Tongjiang Granules preclinical research materials and all technical secrets and patents during the clinical application period owned by Xiyuan Hospital of Chinese Academy of Chinese Medical Sciences in 2018, with a transaction amount of 10 million yua.
Jianmin Pharmaceutical Group stated that after the development of Tongjiang Granules is completed, it will fill the gap in the domestic market of Chinese patent medicines for the treatment of gastroesophageal reflux diseas.
At the same time, as a manufacturer of Chinese patent medicines, Tongjiang Granules will also help to supplement the company's characteristic traditional Chinese medicine varieties and enrich the company's product.
lin.
Tecoro
Tecoro
On August 9th, Jiaxing Tecoro Biotechnology C.
, Lt.
(hereinafter referred to as "Tecoro"), which focuses on the research and development of new skin drugs, officially announced that its pipeline TDM-180935 for the treatment of atopic dermatitis (AD) has been Obtained the US FDA clinical trial license and received the official approva.
It is understood that TDM-180935, which has obtained a clinical trial license this time, is the first small molecule external drug to enter clinical trials among several preclinical candidate compounds screened by Tecorro in the JAK inhibitor R&D platform, belonging to JAK1/Tyk2 Dual-target inhibitor.
Preclinical data show that its topical application shows good dose-related efficacy in three animal models of atopic dermatiti.
Hengrui Medicine
Hengrui Medicine
Hengrui Medicine announced on August 9 that the company has received the approval and issuance of the "Drug Clinical Trial Approval Letter" for HR20014 injection by the State Drug Administration ("NMPA"), and will launch clinical trials for diabetes indications in the near futur.
tes.
It is said that HR20014 injection is intended for clinical use in the treatment of diabete.
HR20014 injection can achieve a stable and continuous hypoglycemic effect, taking into account the control of fasting blood sugar and postprandial blood suga.
After inquiries, no similar products of domestic enterprises have been approved for listing at present, and there is no relevant sales dat.
Up to now, HR20014 injection-related projects have invested about 164 million yuan in research and developmen.
Sinovac Pharmaceuticals
Sinovac Pharmaceuticals
On August 2, Kexing Pharmaceutical announced that the clinical trial application for PEGylated human granulocyte stimulating factor injection submitted by the company has been accepte.
The drug is a long-acting human granulocyte-stimulating factor (long-acting G-CSF) product, which is manufactured by Kexing Pharmaceuticals by coupling and modification of human granulocyte-stimulating factor (G-CSF) produced by polyethylene glycol and gene recombination technolog.
It is worth noting that, as a long-acting whitening needle, pegylated human granulocyte stimulating factor injection is a blockbuster product deployed by many companie.
At present, there are 4 domestic long-acting Baiyao products approved for listing in the domestic market, including Qilu Pharmaceutical, CSPC, Hengrui Medicine, and Shandong New Era Pharmaceutical.
In addition, there are 3 companies whose listing applications are under review and approval, including Shuanglu Pharmaceutical's polyethylene glycol recombinant human granulocyte-stimulating factor injection, and Yifan Pharmaceutical's ebergrastim alpha injectio.
, Topefilgrastim injection of Tebao Bio,et.
Epilogue
Epilogue
In general, under the general trend of domestic innovation, the approval of new drug clinical applications is accelerating, but it should be noted that there is always a great risk of failure in new drug research and developmen.
While pharmaceutical companies continue to accelerate the clinical development of new drugs, news of failures and terminations of clinical trials is also increasin.
For example, on August 8, Kanghong Pharmaceutical announced that its subsidiary, Hongji Bio, withdrew its application for clinical trials of KH631 ophthalmic injectio.
.
In this regard, the industry believes that benefits often coexist with risks, and companies that want to enter the market need to be cautious, and they have already entered the marke.
Businesses are ready to fail at any tim.
