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The innovation pattern of China's biopharmaceuticals
Time of Update: 2021-11-13
Anti-tumor drugs accounted for the largest proportion, almost half of the total number of generic names declared Figure 2 Distribution of innovative biological drug treatment fields declared in 2016-2020 (calculated by generic name) Approval pattern of innovative biopharmaceuticals in ChinaApproval pattern of innovative biopharmaceuticals in China Figure 3 shows the changes in the number of generic names of innovative biological drugs approved in China and the United States .
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Where are the opportunities for the development of the vaccine industry in the post-epidemic era?
Time of Update: 2021-11-13
At the same time, Sanofi Pasteur also signed a strategic cooperation agreement with the Peking University Public Health and Major Epidemic Prevention and Control Strategy Research Center to jointly explore new ideas for prevention and immunity, help China's public health professional capacity and system upgrade, and enhance respiratory infections Disease detection capabilities .
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Express｜More than 500 million US dollars to help develop specific cytokine therapies, Merck reached a cooperation
Time of Update: 2021-11-13
Our alternative cytokine agonist platform has produced a new class of cytokine therapeutic drugs, which aim to Deliver selective immunotherapies for the treatment of autoimmune diseases and cancer .
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my country’s first "Technical Guidelines for the Real World Research of Chinese Patent Medicines" has been issued and implemented
Time of Update: 2021-11-13
On October 25, 2021, the National Group Information Platform released the "Technical Guidelines for the Real World Research of Chinese Patent Medicines" (T/CATCM011—2021) , which was drafted by the China Association of Chinese Materia Medica and other organizations.
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Two blockbuster Class 1 new drugs were submitted for production for the first time; 22 companies deployed 19 first imitations, and this oral psoriasis drug was looted
Time of Update: 2021-11-13
SummarySummary In October, CDE undertook a total of 915 applications for drug registration For the first time, the 7 stock varieties have the consistency evaluation of the enterprise declaration Two blockbuster Class 1 new drugs were first declared for listing Zejing Bio-Donafenib Toluenesulfonate Tablets New Indications Reported for Production 17 varieties apply for imitation, 2 varieties apply for import 5.
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The 43rd batch of "passed consistency evaluation" list is here
Time of Update: 2021-11-13
List of varieties passed by consistency evaluationList of varieties passed by consistency evaluation The Insight database (https://db.
6% According to Insight consistency evaluation database statistics, the current start-up rate of all varieties to be evaluated is 17.
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Multinational pharmaceutical company Q3 report card: Pfizer Merck leads the growth rate, and the prospects of each company's TOP3 competitive products are different
Time of Update: 2021-11-13
Pfizer's new crown vaccine shows its prowess and Merck may be approved the first oral new crown treatment drug In the third quarter, in terms of revenue growth rate, multinational pharmaceutical companies all delivered good answers .
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The first class 1 new cerebrovascular Chinese medicine is declared for production!
Time of Update: 2021-11-13
Cinda Bio's PD-1 7th indication was declared and listed On November 4, Innovent's PD-1 inhibitor Daboshu® (sintilimab injection) combined with chemotherapy (oxaliplatin + capecitabine) first-line treatment of unresectable locally advanced and recurrent unresectable Or metastatic gastric or gastroesophageal junction adenocarcinoma (G/GEJ) new indications for marketing applications have been accepted .
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Analyzing the data indicators of listed companies in three years, we have summarized the five major characteristics of the development of China's pharmaceutical and health industry
Time of Update: 2021-11-04
Table 1: Pharmaceutical and health companies listed on the Science and Technology Innovation Board of the Shanghai Stock Exchange Source: Flint Creation Database (data as of August 2021) 02 The total revenue of listed companies is approaching 2 trillion yuan, and the profit margin and R&D investment intensity have steadily increased The overall development of China's listed companies in the field of medicine and health is improving .
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Domestic Class 1 new drugs broke out! Cinda, Hausen... the sales of 12 innovative drugs soared, and the 21st Class 1 new drug was born this year
Time of Update: 2021-11-04
Since 2021, the number of Class 1 new drugs approved for marketing for the first time in China has reached 21, focusing on the fields of anti-tumor and anti-infection, and 9 new drugs are expected to participate in a new round of medical insurance negotiations .
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Starting from the cost of 1.2 million anti-cancer drugs: can we use 200,000 CAR-T?
Time of Update: 2021-11-04
There is a view in the industry that in the current R&D and preparation process, all key raw materials and auxiliary materials of CAR-T are imported from abroad at present and in the future, even if the domestic CAR-T is also the same .
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Huadong Medicine has obtained exclusive licenses for 8 new drug candidates in 20 countries and regions in Asia
Time of Update: 2021-11-04
According to the press release, the hydroxy dendrimer therapy developed by Ashvattha has good disease cell targeting.
com/s/9nqIG3_I-rmqY2cTQDPV0w[1] Huadong Medicine and Ashvattha of the United States signed an equity investment agreement and product exclusive license agreement.
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9 new drugs approved clinically from Nuocheng Jianhua, Heyu Medicine, Tianjing Bio, etc.
Time of Update: 2021-11-04
Heavenly creatures: Efeinterleukin alpha Mechanism of action: long-acting recombinant human interleukin 7 drug On October 18th, Tianjing Bio-Bio announced that the Drug Evaluation Center of the National Medical Products Administration of China has officially approved the initiation of the combination therapy of efilinterleukin alpha (also known as T107/GX-17/NT-7) and anti-PD-1 antibody Phase 2 clinical trials for advanced solid tumors (including triple negative breast cancer and head and neck cancer) .
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First domestic product: Chia Tai Tianqing declares "Mepolizumab" similar drug
Time of Update: 2021-11-04
From CDE official website Mepolizumab was developed by GlaxoSmithKline and was approved by the FDA in November 2015 to treat severe and eosinophilic phenotypic asthma in patients 12 years of age and older.
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How should the FDA reshape the accelerated approval process?
Time of Update: 2021-11-04
A recent study showed that four cancer immunotherapies approved by the FDA (Accelerated Approval) were withdrawn due to invalid confirmatory trials, and Medicare spent on these invalid therapies between 2017 and 2019.
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Song Ruilin: What is the "blocker" in the development of China's pharmaceutical innovation?
Time of Update: 2021-11-04
Song Ruilin, executive chairman of China Pharmaceutical Innovation Promotion Association, shared the current problems facing China's pharmaceutical innovation and development Chairman Song Ruilin said that since the establishment of the major national new drug creation project in 2008, policy guidance has been a distinct trend in the development of China’s biomedical industry.
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BeiGene and Nanolek announced that Baiyueze® (Zebutinib) was approved in Russia for the treatment of patients with relapsed or refractory mantle cell lymphoma
Time of Update: 2021-11-04
This is the first pharmaceutical approval of Baiyueze® in Russia At present, Baiyueze® has been approved for the treatment of mantle cell lymphoma in 10 countries, including the United States, China,
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Boehringer Ingelheim's monoclonal antibody Cyltezo obtains first bio-interchangeable drug license
Time of Update: 2021-11-04
According to the company’s patent settlement agreement with AbbVie, Boehringer Ingelheim will not be able to launch Humira generics until July 1, 2023, but the regulatory approval of Cyltezo will mean that pharmacists can use Cyltezo instead of Humira at the pharmacy counter.
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FDA approves the first interchangeable biosimilar of adalimumab from Boehringer Ingelheim
Time of Update: 2021-11-04
Compared with biosimilar, interchangeable product Therefore, a product approved as an interchangeable product means that the FDA has concluded that it can substitute the reference drug without consulting the prescriber .
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New antipsychotic drug!
Time of Update: 2021-11-04
Recently, the company announced the launch of Lybalvi (olanzapine/samidorphan) in the US market, which is a new, once-daily atypical antipsychotic drug for the treatment of: (1) adult patients with schizophrenia; (2) double Adult patients with phase I disorder .
