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Entering the fast lane of development, Keji Pharmaceutical's first overseas cGMP production plant started operation in the United States!
Time of Update: 2022-05-28
Officials from the local government and economic development departments of North Carolina and Durham, the United States, the service providers related to the construction of the RTP production plant, and Keji Pharmaceutical USA Important partners of the company attended the ceremony together .
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Tecoro TDM-105795 Initiates Phase Ib Human Clinical Trial of Androgenetic Alopecia
Time of Update: 2022-05-28
The Phase 1b clinical trial is a 28-day multiple dose escalation study, which is a "randomized, double-blind, vehicle-controlled, parallel group, multiple dose escalation study to evaluate the efficacy of TDM-105795 in patients with androgenic Safety, tolerability and pharmacokinetics in healthy male subjects with alopecia .
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Upstart BTK inhibitor sells at least $11 billion globally in 2021
Time of Update: 2022-05-28
Globally Approved BTK Inhibitors(Source: CITIC Securities Research)Sales of major BTK inhibitors have continued to grow since their launch .
(Data source: annual reports of each company, tirabrutinib sales in 2021 are the data from listing to March 2021)At present, many domestic pharmaceutical companies are also deploying BTK inhibitors .
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Claudin 18.2 of Chuangsheng Group Completed the First Patient Dosing in Phase IIa Clinical Trial
Time of Update: 2022-05-28
2 monoclonal antibody TST001 combined with cisplatin and gemcitabine for the first-line treatment of locally advanced or metastatic biliary tract cancer without systemic therapy has completed the first patient dosing in a Phase IIa clinical trial in China .
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Bayer's Kerendia gets EU approval to compete with AZ and Eli Lilly's SGLT-2 inhibitors
Time of Update: 2022-05-28
CompilenewbornRecently, Bayer's new kidney disease drug Kerendia (finerenone, feneridone, 10mg or 20mg) was approved in the European Union, the drug is the first non-steroidal, selective mineralocorticoid receptor antagonist (MRA), Indicated for the treatment of chronic kidney disease (CKD, stages 3 and 4 with proteinuria) associated with type 2 diabetes (T2D) in adult patients .
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Treatment of patients ≥ 12 years old! US FDA approves Lubin Pharmaceuticals Solosec supplemental new drug application
Time of Update: 2022-05-28
Bacterial vaginosis is a common vaginal infection, and trichomoniasis is the most common non-viral, curable sexually transmitted infection (STI) .
Notably, Solosec is the first and only single-dose oral prescription antimicrobial approved for both BV and trichomoniasis .
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Eisai/Mersk & Co. Lenvima + Keytruda approved in Taiwan for the treatment of advanced kidney cancer
Time of Update: 2022-05-28
The results showed that, compared with sunitinib, Keytruda+Lenvima was statistically significant in multiple efficacy endpoints (overall survival [OS], progression-free survival [PFS], objective response rate [ORR]) Significant improvement in significance: (1) a 34% reduction in the risk of death (HR=0.
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13 kinds of medicines in short supply implement provincial-level fixed-point reserve procurement
Time of Update: 2022-05-28
On February 25th, the Jiangsu Provincial Public Resource Trading Center forwarded the "Provincial-level fixed-point reserve procurement and supply of 13 drugs such as chlorpyrifosin injection" jointly issued by the Jiangsu Provincial Health and Health Commission, the Food and Drug Administration, and the Medical Insurance Bureau.
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Hengrui Medicine's GnRH receptor antagonist SHR7280 tablets was approved for clinical use
Time of Update: 2022-05-28
Excessive levels of estradiol hormone can lead to the occurrence and development of uterine fibroids.
Therefore, by regulating GnRH receptors and reducing the levels of LH and FSH, uterine fibroids can be treated .
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For chronic cough!
Time of Update: 2022-05-28
Recently, the official website of CDE showed that Hengrui Medicine’s clinical trial application for HRS-2261 tablets was approved for the treatment of chronic cough .
It is estimated that 5%-10% of adults worldwide suffer from chronic cough, and there is a huge clinical need .
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Int's Lesorb fully degradable sinus drug stent completes clinical enrollment
Time of Update: 2022-05-28
With the continuous increase in the number of patients, the average annual compound growth rate of the market capacity of ENT-related medical devices is also increasing.
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The FDA has changed coaches!
Time of Update: 2022-05-28
RBC analysts wrote: "We can expect that the FDA will tighten its policy in the future to review post-marketing confirmatory clinical trials for accelerated approval drugs .
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Huahai Pharmaceutical's subsidiaries Huaaotai Bio and Huabo Bio HB0028 Injection were approved for clinical use
Time of Update: 2022-05-28
T lymphocytes, inhibit tumor growth; at the same time, the anti-TGF-β part of HB0028 can bind to TGF-β, relieve TGF-β-mediated immunosuppression of T cells and natural killer cells, regulatory T cell activation, Factors that promote tumor growth and metastasis, such as tumor angiogenesis and epithelial-to-mesenchymal transition .
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Fosun Pharma's holding subsidiary ORIN1001 tablet was approved for drug clinical trial
Time of Update: 2022-05-28
As of the date of this announcement, the new drug is in Phase I clinical trials in the United States for the treatment of advanced solid tumors and idiopathic pulmonary fibrosis, respectively, for relapsed, refractory, and metastatic breast cancer (including triple-negative breast cancer) ) has been certified by the US FDA Fast Track Development Program (i.
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Another new crown drug phase III clinical failure company's share price plummeted 80%
Time of Update: 2022-05-28
On February 21, Synairgen announced that the international Phase III SPRINTER clinical trial of SNG001 in hospitalized patients with new coronary pneumonia did not meet its primary or key secondary efficacy endpoints, but demonstrated a favorable safety profile and was well tolerated in this population .
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$2 billion to replace a new drug!
Time of Update: 2022-05-28
The report analyzes the 2021 R&D return trends of 15 leading global biopharmaceutical companies, the impact of the COVID-19 pandemic on the R&D pipeline and how it is changing the drug development paradigm (IRR) has improved a lot .
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The seventh batch of national mining will open bids for nearly 200 pharmaceutical companies to enter the bureau
Time of Update: 2022-05-28
The Hunan Provincial Medical Insurance Bureau stipulated in the "Notice on Submitting the Purchase Data Related to the Scope of the Seventh Batch of Nationally Organized Centralized Purchase of Drugs" that the review time of the county, city and state medical insurance departments is from February 17, 2022 to 2022 At 24:00 on February 21, 2019 (that is, today) .
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For hives!
Time of Update: 2022-05-28
According to the latest announcement on the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration, the QGE031 injection submitted by Novartis has obtained the implied license for clinical trials, and the indication is chronic induced urticaria .
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Qianyuan Pharmaceutical: There is no case of using voluntary information disclosure to cater to market hot spots to speculate on the stock price
Time of Update: 2022-05-28
On the morning of February 24, Qianyuan Pharmaceutical issued an announcement replying to the letter of concern of the Shenzhen Stock Exchange.
The Entrusted Processing Cooperation Agreement is a framework agreement for cooperation between the two parties.
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6 provinces form a Chinese patent medicine centralized procurement alliance, and the large-scale Chinese patent medicine alliance procurement registration begins
Time of Update: 2022-05-27
On March 17, the Guangdong Provincial Drug Trading Center issued the "Notice on Viewing Information about Guangdong Alliance Qingkailing and other Chinese patent medicines for centralized procurement
