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Biotech TIGIT monoclonal antibody was approved for clinical use
Time of Update: 2021-08-29
On July 7, the official website of CDE showed that Biotec TIGIT monoclonal antibody BAT6021 was approved for clinical use .
In addition, Biotech also owns another TIGIT monoclonal antibody candidate drug BAT6005, which has also been declared for clinical use .
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Haisco's Class 1 innovative drug HSK16149 was approved for Phase II clinical adjuvant opioid analgesia
Time of Update: 2021-08-29
On August 2, Haisco issued an announcement stating that its self-developed Class 1 innovative drug HSK16149 Capsule Phase II clinical trial was approved by the State Food and Drug Administration to assist opioid analgesia .
HSK16149 has completed two health phase I clinical trials .
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5 COVID-19 drugs included in the EU priority accelerated review: 4 antibodies and 1 JAK inhibitor
Time of Update: 2021-08-29
Eli Lilly’s antibody cocktail bamlanivimab/etesevimab is the first drug approved in the United States to treat patients at high risk of developing severe COVID-19 .
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Hengrui Medicine's long-acting local anesthetic drug HR18034 for injection was approved for clinical use
Time of Update: 2021-08-29
To this end, the company has developed a new long-acting drug for postoperative analgesia-HR18034 for injection, in order to maintain the analgesic effect in patients for several days after surgery, thereby reducing the frequency of clinical administration, further reducing the risk of toxicity, and prolonging the effective analgesic time.
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Innovative drugs for treating NASH reach all primary endpoints of Phase 2a trial
Time of Update: 2021-08-29
This randomized single-blind, multi-center, placebo-controlled Phase 2a clinical trial aims to study the safety, tolerability and drug resistance of CRV431 in NASH patients with moderate (F2) or advanced (F3) liver fibrosis.
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The State Food and Drug Administration approved the registration of 162 medical device products
Time of Update: 2021-08-29
Medical Network News on August 12 On August 11, the official website of the State Food and Drug Administration issued an announcement on the approval and registration of 162 medical device products (July 2021) (No.
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The third domestically produced lenvatinib is here!
Time of Update: 2021-08-29
The listing of domestic generic drugs may further reduce the price of this variety, which will further benefit the patient population .
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Is ivermectin miraculously effective in treating new crowns?
Time of Update: 2021-08-29
The focus of the study was on the infectivity of the virus, and the results found that only 30% of patients taking ivermectin were infectious after 6 days of treatment .
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Pfizer's third-generation ALK inhibitor and Cinda Bio-FGFR inhibitor are planned to be included in the priority review in China
Time of Update: 2021-08-29
Screenshot from CDE official websitePfizer lorlatinibPfizer lorlatinibThe CDE announcement showed that two applications of Pfizer's lorlatinib tablets (loratinib) have been included in the proposed priority review, and the proposed indications are: for the treatment of one or more ALK tyrosine kinase inhibitors in the past Of ALK-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) patients .
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Compete with HAE's first oral therapeutic drug!
Time of Update: 2021-08-29
Recently, BioCryst launched Orladeyo, the first oral treatment for hereditary angioedema (HAE), and the North Carolina-based biotechnology company has priced Orladeyo lower than its main competitors, Takeda and CSL Behring .
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Faith Medicine's AAV gene therapy is approved for clinical treatment of hemophilia B patients
Time of Update: 2021-08-29
BBM-H901 injection is an AAV gene therapy drug developed by Faith Medicine, which aims to introduce human coagulation factor IX (Factor IX, FIX) gene into hemophilia B patients through intravenous administration, thereby improving and maintaining the patient's body for a long time.
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Phase III study of CXCR4 inhibitor fails, Fosun Pharma has China rights
Time of Update: 2021-08-29
Polyphor Dahuan Technology Platform (Source: Polyphor AG)The FORTRESS study (POL6326-009) is a randomized, open-label, positive-controlled, international multicenter phase III study, which aims to evaluate intravenous balixafortide combined with eribulin versus eribulin monotherapy in the treatment of HER2-negative local Efficacy, safety and tolerability of recurrent or metastatic breast cancer .
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After Varenicline, Hausen Pharmaceuticals is expected to win the first imitation of Cabozantinib tablets
Time of Update: 2021-08-29
Hausen Pharmaceuticals is the first domestic company to submit an application for the listing of a generic version of Cabozantinib Malate Tablets.
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Hainan builds a medical recruitment and procurement price guidance mechanism to guide medical prices back to a reasonable space
Time of Update: 2021-08-29
Chinanews. com Haikou, July 5 (Reporter Wang Ziqian) The reporter learned from the press conference of the thirteenth batch of institutional innovation cases at the Hainan Free Trade Port on the 5th t
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Henan Provincial Food and Drug Administration issued the first phase of 2021 medical device quality announcement
Time of Update: 2021-08-29
A batch of disposable medical masks produced by Henan Shengyuan Medical Sanitary Materials Co.
One batch of medical protective masks produced by Henan Yadu Industrial Co.
produced a batch of disposable medical masks, and the mask bands were unqualified .
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Zebutinib has another major phase 3 study with positive data
Time of Update: 2021-08-29
SEQUOIA is a randomized, multicenter, global phase 3 trial with more than 580 patients enrolled, aiming to evaluate the use of zebutinib and bendamustine in combination with rituximab (B+R) for treatment The effectiveness and safety of newly treated CLL or small lymphocytic lymphoma (SLL) patients .
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Hengrui Carrelizumab is approved by the FDA for Phase III clinical trials in the U.S.
Time of Update: 2021-08-29
Article source: Medical Rubik's Cube InfoToday, Hengrui Pharmaceuticals announced that it has received a letter from the US FDA regarding the approval of the use of carrelizumab for injection in combination with famitinib malate capsules for the phase III clinical trial of advanced non-small cell lung cancer .
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The Phase II clinical trial application of Celinisolone for the treatment of MF by Deqi Pharmaceuticals was accepted by the NMPA
Time of Update: 2021-08-29
Deck Pharmaceuticals recently announced that the National Medical Products Administration (NMPA) has accepted the world's first oral XPO1 inhibitor selinexor in a phase II clinical trial of monotherapy for patients with myelofibrosis (MF) in China .
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Merck voluntarily revokes Keytruda's accelerated approval for third-line treatment of gastric cancer in the U.S.
Time of Update: 2021-08-29
CompileriverOn July 1, US Eastern time, Merck’s official website announced that it would voluntarily withdraw an indication previously approved by the FDA for Keytruda, specifically: for the treatment of recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) glands Cancer patients whose tumors express PD-L1 [combined positive score (CPS) ≥ 1] .
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Procurement of these varieties or selection of proprietary Chinese medicines
Time of Update: 2021-08-29
With centralized procurement of proprietary Chinese medicines, three types of varieties may be selected. Under the trend, how should companies break through and innovate?0101Possible varieties of cen