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Futu |" FDA experts asked Cinda PD-1 to increase clinical research in the United States

author:Futu Hong Kong stocks

The PCSK9 target gives the pharmaceutical community all the tools for new drug development

Recently, the C&EN website of the American Chemical Society took stock of the progress of new drug development in the field of PCSK9 protein. Several pharmaceutical and biotechnology companies are targeting this target using almost all conceivable therapeutic models.

Futu |" FDA experts asked Cinda PD-1 to increase clinical research in the United States

Last December, the U.S. FDA approved Novartis' Leqvio, a "first-in-class" siRNA therapy that significantly reduces the expression of the PCSK9 protein with just two injections per year, thereby significantly reducing the level of low-density lipoprotein cholesterol (LDL-C).

The latest "Nature": Artificial design of protein, the team of the University of Science and Technology of China has opened up a new route

In a paper released this week by the top academic journal Nature, a research team led by Professor Liu Haiyan and Associate Professor Chen Quan of the University of Science and Technology of China showed a new route designed from scratch:

In particular, it provides a systematic solution to a major problem of artificial design of proteins, how to fully explore the structure space of protein backbones.

Futu |" FDA experts asked Cinda PD-1 to increase clinical research in the United States

Reviewers in the journal Nature spoke highly of the findings, arguing that the new approach "portrays multidimensional features that are unattainable by more traditional statistical methods, with sufficient novelty and practicality."

14 to 1! Fda expert committees asked Cinda/Eli Lilly PD-1 to increase clinical research on the United States

Under the almost general pessimistic wait-and-see attitude, the results of the first domestic PD-1 to break through the FDA's exam finally came, which is not only a company fighting, but a whole industry breathing together and sharing a common fate in the exam, with an extremely important weather vane effect.

At 10:00 a.m. Eastern Time on February 10 (23:00 Beijing time on February 10), the Cinda/Eli Lilly PD-1 antibody Sindilimab officially ushered in the review meeting of the FDA Oncologic Drugs Advisory Committee (ODAC).

Futu |" FDA experts asked Cinda PD-1 to increase clinical research in the United States

That is to say, from most of the expert opinions of this ODAC, Cinda/Eli Lilly PD-1 is not recommended to be approved directly.

ODAC experts believe that the Orient-11 trial, conducted only in China and not in global multicenter clinical trials, does not meet the description of the ICH E17 guidelines, and given the nature of a single country, orient-11 results are not applicable to patients in the United States. There is no doubt that this is a "big test" that has attracted the attention of the Chinese and even global pharmaceutical industry, and the attention of global live broadcasting is hot.

AstraZeneca's oxetinib sales exceed $5 billion and vaccine revenues are nearly $4 billion

On February 10, AstraZeneca announced its 2021 results. For the full year, the company achieved revenue of $37,417 million, an increase of 41% year-over-year (38% in CER terms), of which Q4 increased by 62% to $12,011 million. Covid-19 vaccines contributed $3.917 billion in sales in 2021, and AstraZeneca's total revenue after excluding vaccines still increased by 26%.

Futu |" FDA experts asked Cinda PD-1 to increase clinical research in the United States

AstraZeneca looks ahead to its development prospects for the next 3 years and beyond. Based on a number of blockbuster drugs, AstraZeneca expects industry-leading double-digit growth from 2022 to 2025.

Each province reported on this year's drug procurement plan

According to the latest news in the industry, the relevant departments of the national procurement with quantity recently issued a "Letter on Submitting the Priorities and Related Considerations of the Centralized Procurement of Drugs and Medical Consumables at the Provincial Level (Interprovincial Alliance) in 2022": According to this letter, each province should clarify the varieties and quantities of procurement carried out by their own provinces this year.

According to the author's incomplete statistics, at present, the progress of each province in the country is different from completing 350 tasks. (The progress of some provinces is listed below).

Futu |" FDA experts asked Cinda PD-1 to increase clinical research in the United States

According to the current calculations, at the end of this month, Guangdong will carry out formal quotation work, and Guangdong has ended the hard bones of many other major pharmaceutical provinces waiting to be "gnawed". This is basically a microcosm of the purchase of drugs in 2022.

Jiuan Medical's COVID-19 self-test kit has delivered 105 million copies to ACC in the United States

On February 10, Jiuan Medical issued an announcement that its subsidiary, iHealth Labs, has delivered about 105 million copies of iHealth kit products, and the performance of the above contract will have a positive impact on the company's operating income and operating profit in 2022.

Futu |" FDA experts asked Cinda PD-1 to increase clinical research in the United States

However, at present, the epidemic situation in the United States has eased, and there may also be cases that have not been counted because the self-test with the kit has not been actively reported. Contracts and orders that the Company is performing have not been affected.

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