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Hengrui Medicine's 1.3 billion innovative drug Punaburin will be another wealth code?
Time of Update: 2021-10-09
Subsequently, at the ESMO annual meeting in September 2021, the international multi-center phase III study (DUBLIN-3 ) Announced the detailed results for the first time, significantly improved the survival benefits of patients, and observed a long-tailing effect survival curve, significantly reduced the incidence of grade 4 neutropenia (CIN), and improved the quality of life, which is expected to become the field The new standard back-line treatment plan .
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Coron's TROP2-ADC SKB264 Sino-US Phase I clinical results will be announced at the 2021 ESMO Annual Meeting
Time of Update: 2021-10-01
In terms of clinical effectiveness, a total of 17 patients received at least one efficacy evaluation, and the enrolled population were all patients with advanced or metastatic solid tumors who had failed multi-line treatment .
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FDA and EMA launch a pilot program for parallel scientific advice on complex generic drugs-hybrid products
Time of Update: 2021-10-01
The goal of the PSA pilot program is to provide a mechanism for FDA and EMA reviewers to exchange views with applicants on scientific issues during the development phase of complex generic/hybrid products, which usually use traditional bioequivalence methods It is more challenging to develop .
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New drug for ulcerative colitis (UC)!
Time of Update: 2021-10-01
" Rinvoq clinical data Ulcerative colitis (UC) is a chronic, idiopathic, immune-mediated inflammatory bowel disease (IBD) of the large intestine, which can cause persistent mucosal inflammation, extending from the rectum to the closer colon to varying degrees .
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Reach a cooperation!
Time of Update: 2021-10-01
According to the press release, the product portfolio introduced by Saisheng Pharmaceutical will selectively deliver payload pan-PI3K inhibitors to solid tumors by combining with activated HSP90.
com/s/zVKvLYaLEE2z2goz6Q0HBg[1] Saisheng Pharmaceutical and Tarveda reached an exclusive license agreement in Greater China for HSP90-PI3K small molecule conjugate drug.
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SinoVision, China Antibody and Genting Shinyao reached a global cooperation agreement on BTK inhibitors
Time of Update: 2021-10-01
On September 17, Sinovation, China Antibody and Genting Shinya announced that they have reached an exclusive global cooperation agreement, granting Genting Shinya the right to develop and commercialize XNW1011 (SN1011) worldwide in the field of kidney disease .
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The memory of CSCO's ten-year new drug: let history tell the future
Time of Update: 2021-10-01
At that time, multi-targeted TKI was still "sweet and sweet"-the world's first small-molecule anti-angiogenesis targeted drug approved for the treatment of advanced gastric cancer emerged, but today it seems that apatinib has expanded after its launch in 2014 The pace of the indication was not smooth, and it was not until January this year that the second indication (second-line advanced liver cancer) was finally approved .
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The U.S. FDA grants Zebutinib accelerated approval for the treatment of relapsed or refractory marginal zone lymphoma
Time of Update: 2021-10-01
A multicenter, pivotal Phase 2 MAGNOLIA clinical trial (NCT03846427) evaluated the efficacy of Baiyueze® in R/R MZL patients who have received at least 1 line of anti-CD20 therapy .
68), and the complete remission (CR) rate reached 20%; based on the evaluation of the priority PET-CT scan, the ORR was 67% (95% CI: 54.
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Interpretation of the policy environment for the development of social medical services in the next 10 years
Time of Update: 2021-10-01
In the "14th Five-Year Plan Outline", there are only six words for the society to run medical services, and the 13th Five-Year Plan recommends "encourage social forces to establish health services, and promote non-profit private hospitals and public hospitals.
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Biomedicine enters a new "Golden Decade"
Time of Update: 2021-10-01
However, China's biomedical industry relied on the opportunities brought by continuous policy reforms to burst out innovative vitality in the face of adversity: the structure of the new crown virus was analyzed in the first time, and the diagnostic reagents were quickly developed.
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U.S. government purchases 1.4 million doses of REGEN-COV antibodies
Time of Update: 2021-10-01
6 million doses of new coronary pneumonia COVID-19 treatment drug REGEN-COV purchase agreement reached between Regeneron and the US government, the total purchase of the US government from the company's new coronary pneumonia antibody therapy has reached 3 million doses .
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Notice on Publicly Soliciting Opinions on "Chimeric Antigen Receptor T Cell (CAR-T) Product Application and Marketing Clinical Risk Management Plan Technical Guidelines (Draft for Solicitation of Comments)"
Time of Update: 2021-10-01
docx a chimeric antigen receptor T cells (CAR-T) Cell Therapy Product Application and Marketing Clinical Risk Management Plan Technical Guiding Principles Draft.
pdf 1 Chimeric Antigen Receptor T Cell (CAR-T) Cell Therapy Product Application and Marketing Clinical Risk Management Plan Technical Guiding Principles Draft for Comment .
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FDA record in 2021: approved potential blockbuster drugs vs. potential blockbuster drugs to be approved soon
Time of Update: 2021-10-01
According to Fierce Pharma's official website, four potential blockbuster drugs, Argenx's efgartigimod, Utimes's bimekizumab, Roche/Chuwai's abrocitinib, and Pfizer's abrocitinib, are expected to receive FDA approval in the next three months .
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Inexpensive medicines used to save lives by 100,000 new patients every year fall into a crisis of out of stock
Time of Update: 2021-10-01
For another example, the data provided to the health sector by Hanhui Pharmaceutical, a Chinese manufacturer of bleomycin, shows that before July 2020, the price of the drug has been around 122 yuan .
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Policy support, capital favor, the domestic rare disease market can be expected in the future
Time of Update: 2021-10-01
The global rare disease drug market pattern from 2016 to 2024 (Source: Frost & Sullivan Report) Due to the large population base in China, the absolute value of rare diseases is not small.
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"Don't Eat Me" Signal: Inventory of CD47 Products Under Development at Home and Abroad
Time of Update: 2021-10-01
They are in clinical phase III at the highest stage of development at home and abroad, including Forty Seven's magrolimab (Hu5F9-G4) and ALX oncology's ALX-148.
The pioneers of foreign SIRPα fusion protein research and development are mainly Trillium Therapeutics and ALX oncology .
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What is the clinical advantage of domestic PD-(L)1 compared with the products of multinational pharmaceutical companies?
Time of Update: 2021-10-01
In addition, on the basis of crossover trials, the absolute PFS and OS benefits and risk ratios of tereprizumab do not look as impressive as Keytruda's Keynote-189 and 407 studies .
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Precise treatment of elderly cancer patients has become an increasingly tangled medical problem
Time of Update: 2021-10-01
Improve precise treatment decisions for elderly cancer patients:Improve precise treatment decisions for elderly cancer patients: For clinical evidence and trial design, we provide seminar expert lecture materials, including clinical diagnosis and treatment methods; how to judge the benefit of patients, improve and guarantee the quality of life and give priority to survival time (hope for recovery) .
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Zai Lab/Amgen's FGFR2b targeted monoclonal antibody has been certified as a breakthrough therapy in China and the U.S.
Time of Update: 2021-10-01
Zai Lab announced recently that CDE has granted bemarituzumab (FPA144 injection) breakthrough therapy designation (BTD), combined with an improved FOLFOX6 chemotherapy regimen (mFOLFOX6: fluoropyrimidine + leucovorin + oxaliplatin), as a first-line treatment for fibroblasts Growth factor receptor 2b (FGFR2b) overexpression, HER2-negative, metastatic and locally advanced gastric and gastroesophageal junction (GEJ) cancer patients .
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What is the "insider" behind the occupation of large tracts of anticancer drugs in the past 10 years?
Time of Update: 2021-10-01
The reason for the high market sales of immunosuppressive drugs in the past 10 years is still because of "cancer .
Figure 3 2011-2020 global sales statistics of protein kinase inhibitors in TOP100 drugs Data source: Yaozhi global best-selling drug sales database, compiled by Yaozhi Consulting Unexpected performance of vaccine drugsUnexpected performance of vaccine drugs 1.
