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Domestically-made "Class 1/2" innovative drugs that entered the NDA for the first time in 2021
Time of Update: 2022-01-07
For the whole year of 2021, whether it is a category 1 innovative drug or a category 2 improved new drug, which domestically produced varieties will enter the NDA acceptance status for the first time?
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Immunotherapy for small cell lung cancer: the PK of PD-1 and PD-L1
Time of Update: 2022-01-07
SlulimumabOn December 7th, Henlius announced a randomized, double-blind, international multi-center for the PD-1 inhibitor slulimumab combined with chemotherapy in previously untreated extensive-stage small cell lung cancer (ES-SCLC) Phase III clinical study ASTRUM-005 (NCT04063163) reached the primary study endpoint of overall survival (OS) in the first interim analysis .
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The General Administration of Customs of the State Food and Drug Administration added Zhongshan Port in Zhongshan City as a port for drug import
Time of Update: 2022-01-07
As of the date of this announcement, the Guangdong Provincial Institute for Drug Control has begun to undertake the inspection of drugs at the Zhongshan Port in Zhongshan City .
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The State Food and Drug Administration issued 14 registration review guidelines including fluorescence immunochromatographic analyzers
Time of Update: 2022-01-07
48 of the State Administration for Market Regulation), the State Drug Administration has organized and formulated 14 guidelines for registration and review of fluorescence immunochromatographic analyzers (see attachment ) .
Guidelines for registration and review of fluorescence immunochromatographic analyzers 2.
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In 2022, the launch of China's innovative drugs will accelerate again
Time of Update: 2022-01-07
In recent years, under the intensive introduction of a series of policies that favor the development of innovative drugs, a large number of pharmaceutical companies have begun.
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FDA Approves Cortisol Synthesis Inhibitor for Treatment of Severe Endocrine Diseases
Time of Update: 2022-01-07
Recently, Xeris Biopharma announced that the US FDA has approved the cortisol synthesis inhibitor Recorlev (generic name of the drug: levoketoconazole) for the treatment of endogenous hypercortisolemia in adult patients with Cushing's syndrome.
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In order to promote the implementation of Chinese medicine products and medical services, the two companies have joined forces
Time of Update: 2022-01-07
At the same time, Shun Teng International will assist Yiling Pharmaceutical in the registration of patented Chinese medicine products in Hong Kong, and use its current strategic cooperation in Hong Kong to distribute agent store partners, a total of approximately 550 physical stores and approximately 50 stores with in-store promoters.
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The 10 most important new drugs in 2022!
Time of Update: 2022-01-07
According to data predicted by Evaluate Pharma, a well-known pharmaceutical market research organization, a number of potential "blockbuster" R&D projects will become the focus of attention in 2022 .
Table 2 lists the development and valuation of 10 potential "blockbuster" projects in the clinical stage .
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On the same day, these two pharmaceutical companies have new moves in the field of medical beauty
Time of Update: 2022-01-07
The industry believes that with the smooth acquisition of the entire equity of Genesis Biosystems in the United States, the strength of Sihuan's medical and aesthetic product pipeline will be further strengthened in the future .
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The Waigaoqiao base of Hequan Pharmaceutical successfully passed the pre-market inspection of the U.S. FDA for its first preparation project
Time of Update: 2022-01-07
This is the first time that the Waigaoqiao base has completed the FDA pre-market approval inspection for the preparation project, which will help Hequan Pharmaceutical to better provide preparation commercial production services for global customers .
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The difficulty of operation continues to increase, how can pharmacies achieve new growth in performance
Time of Update: 2022-01-07
For example, some time ago, the Shanxi Provincial Food and Drug Administration issued a notice stating that according to the application of Shanxi Jiukang Pharmacy Chain Co.
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The ophthalmology track is promising, and domestic and foreign pharmaceutical companies are increasing their layout through financing
Time of Update: 2022-01-07
In April 2021, Vision Bio, which focuses on the development of innovative drugs for the treatment of ophthalmic diseases such as dry eye and glaucoma, also announced the completion of 300 million yuan in round D financing .
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2022.01.04!
Time of Update: 2022-01-07
On January 4, 2022, CDE continuously issued 4 technical guidelines, three of which are clinically related : "Technical Guidelines for Writing Safety Reference Information in the Researcher's Handb
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The General Administration of Customs adds Zhongshan Port in Zhongshan City as a port for drug import
Time of Update: 2022-01-07
As of the date of this announcement, the Guangdong Provincial Institute for Drug Control has begun to undertake the inspection of drugs at the Zhongshan Port in Zhongshan City .
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Genting Xinyao Gosartuzumab for the treatment of mTNBC listing application accepted in Taiwan, China
Time of Update: 2022-01-07
On January 4, Genting Shinya announced that the Food and Drug Administration of Taiwan, China has accepted the New Drug Marketing Application (NDA) of Sacituzumab Govitecan for the treatment of unresectable locally advanced or metastatic adult patients.
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HER2 dual anti-KN026 combined with chemotherapy for the treatment of gastric cancer is clinically approved
Time of Update: 2022-01-07
KN026-CSP-001 is a randomized, multicenter, phase II/III clinical study to evaluate the effectiveness and safety of KN026 combined with chemotherapy in patients with HER2-positive gastric cancer (including gastric-esophageal junction adenocarcinoma) who have failed first-line treatment , Professor Xu Jianming from the General Hospital of the Chinese People’s Liberation Army served as the principal investigator .
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The "14th Five-Year Plan" National Drug Safety and High-quality Development Plan
Time of Update: 2022-01-07
According to the development goals of the "14th Five-Year Plan", the "Plan" proposes to implement the whole-process supervision of drug safety, support industrial upgrading and development, improve the drug safety management system, continue to deepen the reform of the review and approval system, tighten vaccine supervision, and promote the inheritance and innovation of traditional Chinese medicine.
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The 2021 Sunward Pharmaceutical Auxiliary Innovation Summary Conference was successfully held
Time of Update: 2022-01-07
At the beginning of the meeting, Director Wu of the Technology Center made a summary report on the technical research and development, technical services, product registration, project declaration, as well as topics and innovation work in 2021, so that everyone has a more systematic understanding of this year’s technical innovation work.
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The place has already moved, how far is the national procurement of proprietary Chinese medicines?
Time of Update: 2022-01-07
For example, Kunyao Group stated on the investor interaction platform in September that the centralized procurement of Chinese patent medicines is the general trend, and in the short term it will bring a certain drop in the price of winning bids.
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Chinese medicine companies "hurry up for exams": group competitions, quota purchases!
Time of Update: 2022-01-07
Judging from the rules of the Hubei Union and the Guangdong Union, the top-ranked varieties of Chinese patent medicines in the sales of public medical institutions are mostly included in the centralized procurement category .
