-
Fudan Zhangjiang oral JAK1 inhibitor approved for Phase II clinical use in the treatment of atopic dermatitis
Time of Update: 2021-12-09
Article source: Medical Rubik's Cube InfoOn November 6, Fudan Zhangjiang issued an announcement stating that its Class 1 new drug FZJ-003 capsule is an oral JAK1 selective inhibitor (specification: 25mg, 50mg) for the treatment of moderate to severe atopic dermatitis Phase II clinical trial application Accepted by the Food and Drug Administration .
-
Shiyao Forces 14 Class 1 New Drugs Intensive Attack This Year
Time of Update: 2021-12-09
Author: Jun Chen Zuo ShiOn October 26, CSPC Zhongqi Pharmaceutical's clinical application for SYHX2001 tablets submitted as a new drug category 1 was accepted by the CDE, and the product was declared for clinical use in China for the first time .
-
Heji Pharmaceutical-the world's first ITK inhibitor IND to enter the clinical stage received clinical trial approval
Time of Update: 2021-12-09
S. October 26, 2021/PRNewswire/ - Heji Pharmaceuticals announced that its first ITK inhibitor in the world to enter the clinical development stage, the clinical use of CPI-818 for oral administration The trial application was approved by the NMPA Drug Approval Center for clinical trial approval, and it is intended to be used for relapsed/refractory T-cell lymphoma .
-
AstraZeneca and Inovio terminate 6-year DNA cancer vaccine collaboration
Time of Update: 2021-12-09
In a document published by the US Securities Exchange, Inovio announced that AstraZeneca's Medimmune Limited has terminated the development plan of INO-3112, which is a vaccine candidate called MEDI0457 .
-
New indication for Sanofi's non-calcium-phosphorus-containing binding agent Novila (R) was launched
Time of Update: 2021-12-09
Shanghai, November 2, 2021/PRNewswire/ - Recently, Sanofi, the world's leading biopharmaceutical company, announced that Novila® (sevelamer carbonate) was officially listed in China for a new indication for treatment that has not been carried out Hyperphosphatemia in adults with chronic kidney disease on dialysis .
-
Boehringer Ingelheim's first-in-class immune drug Spesolimab submitted a marketing application in China for the treatment of generalized pustular psoriasis
Time of Update: 2021-12-09
Shanghai, October 26, 2021/PRNewswire/ - On October 25, 2021, Boehringer Ingelheim announced that it has formally submitted a listing application for the new immune drug Spesolimab to the Center for Drug Evaluation (CDE) of the China National Medical Products Administration , Used to treat the onset of generalized pustular psoriasis (GPP) .
-
Lepu Bio-PD-1 declared the second indication: MSI-H solid tumor
Time of Update: 2021-12-09
Author: ArmstrongOn October 26, 2021, the listing application of Lepu Bio's PD-1 monoclonal antibody Pritlizumab (HX008) for the treatment of MSI-H/dMMR solid tumors was accepted by NMPA, which is the second adaptation of the product declaration Disease .
-
First-line treatment prolongs the lives of patients with biliary tract cancer. The combination of PD-L1 inhibitors is better than standard chemotherapy
Time of Update: 2021-12-09
On October 25, 2021, AstraZeneca announced that the blockbuster PD-L1 inhibitor durvalumab (durvalumab, English trade name: Imfinzi) was combined with chemotherapy for the first-line treatment of advanced biliary tract cancer ( BTC) patients reached the primary endpoint in a phase 3 clinical trial .
-
Saisheng Pharmaceutical's Miconazole Oral Patch Nomico® is officially launched commercially
Time of Update: 2021-12-09
Nomico® is a miconazole patch with a unique patented dosage form, which can be quickly released in the oral cavity and maintain a stable antibacterial concentration to treat oropharyngeal candidiasis, once a day, providing patients with a new convenient treatment option .
-
Pfizer sells mid-term TYK2 inflammation drugs or withdraws from competition with Bristol-Myers Squibb
Time of Update: 2021-12-09
After studying a large number of leading inhibitors of inflammatory diseases, Pfizer recently announced that it is preparing to sell its investment portfolio to a new company in exchange for a 25% stake in the startup .
-
It works in 15 minutes and lasts for 6 hours!
Time of Update: 2021-12-09
Retrieved October 29, 2021, from https:// New Data Presented on the Safety and Efficacy of Investigational AGN-190584 as a Potential Novel Treatment for Presbyopia, a Common and Progressive Eye Condition.
Retrieved July 25, 2021, from https:// releases/new-data-presented-on-the-safety-and-efficacy-of-investigational-agn-190584-as-a-potential-novel-treatment-for-presbyopia-a-common-and-progressive-eye- condition-301339937.
com/news-releases/us-food-and-drug-administration-approves-vuity-pilocarpine-hci-ophthalmic-solution-1-25-the-first-and-only-eye-drop-to-treat -presbyopia-age-related-blurry-near-vision-301412259.
-
34 drug registration certificates including mercury bromide solution were cancelled
Time of Update: 2021-12-09
Registration certificate .
Attachment: Catalogue of Cancellation of Drug Registration Certificate
-
The first in China!
Time of Update: 2021-12-09
Article source: Medical Rubik's Cube InfoAuthor: Shi BeiOn November 1, the clinical application of the bispecific antibody HLX35 targeting EGFR and 4-1BB dual targets by Henlius was officially accepted by the State Food and Drug Administration .
-
3 billion large varieties were looted, Guangzhou pharmaceutical companies are about to be approved
Time of Update: 2021-12-09
com, lansoprazole will be the TOP5 drug for peptic ulcer treatment in public medical institutions in China in 2020, with sales exceeding 3 billion yuan .
-
New IL-36 receptor monoclonal antibody takes a critical step in EU listing, and also submits marketing application in China
Time of Update: 2021-12-09
On October 29th, Boehringer Ingelheim announced that the European Medicines Agency (EMA) has accepted an application for marketing authorization (MAA) for the interleukin-36 receptor (IL-36R) inhibitor spesolimab for treatment Onset of generalized pustular psoriasis (GPP) .
-
LH-1802 Capsules of Lianhuan Pharmaceutical obtained the "Notice of Drug Clinical Trial Approval"
Time of Update: 2021-12-09
On November 9, Lianhuan Pharmaceutical issued an announcement stating that it had recently received the "Drug Clinical Trial Approval Notice" for LH-1802 capsules (specification: 0.
Recently, clinical trials of relapsed or refractory acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) have been carried out .
-
Lepu Bio-Putlizumab plans to be included in the priority review for the treatment of MSI-H/dMMR advanced solid tumors
Time of Update: 2021-12-09
On October 28th, the CDE official website revealed that Lepu Biologic’s Pucotenlimab injection (pucotenlimab, HX008) is planned to be included in the priority review for the treatment of highly unstable microsatellites ( Patients with advanced solid tumors with MSI-H) or defective mismatch repair (dMMR) .
-
Genetron Health and NeoGenomics reached a strategic cooperation to help global oncology drug research and development
Time of Update: 2021-12-09
This cooperation, combined with the advantages of Xinjihao's global pharmaceutical services and clinical trials, and Genetron Health's experience in the localization of global innovative drugs, will help both parties to comprehensively improve their drug R&D support and service capabilities, and enable the company to better serve To meet the needs of global drug research and development and clinical projects .
-
Potential curative therapy for hepatitis B has entered a critical development stage, and the virus can continue to be suppressed after the drug is stopped
Time of Update: 2021-12-09
Moreover, early clinical trial results showed that after 28 days of ATI-2173 medication, even if the medication is stopped, the patient's HBV DNA level can maintain a long time without rebound .
Reference materials:[1] Antios Therapeutics Raises $75 Million in a Series B-1 Funding to Advance Clinical Programs for HBV.
-
Suzhou Ruibo Biotechnology Co., Ltd. uses ArisGlobal's LifeSphere® MultiVigilance solution to improve its clinical trial data management
Time of Update: 2021-12-09
Ruibo Bio will use the Chinese and English versions of ArisGlobal's LifeSphere Multivigilance to manage its drug safety data and meet the regulatory requirements for its products to enter the clinical trial phase .