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Tianyan Pharmaceutical's Phase Ib/II clinical trial of CTLA-4 mAb combined with pembrolizumab was approved by FDA
Time of Update: 2022-05-27
S. FDA approved Tianyan to conduct a Phase Ib/II new drug clinical trial of its anti-CTLA-4 monoclonal antibody ADG126 and anti-PD-1 antibody pembrolizumab .
ADG126 safe antibody can achieve specific activation in the tumor microenvironment, enhance therapeutic effect through strong clearance of regulatory T cells, and maintain physiological function through flexible ligand blockade .
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China Resources Pharma's China Pharmaceutical Research Innovative Drug NIP003 Tablets Obtained Clinical Approval
Time of Update: 2022-05-27
On March 9, according to the official WeChat news of the China Pharmaceutical Research Institute, recently, NIP003 tablets, a new generation anticoagulant of the China Pharmaceutical Research Institute, a subsidiary of China Resources Pharma, obtained the "Notice of Drug Clinical Trial Approval" issued by the NMPA, and was approved for clinical use in the prevention of arteriovenous thrombosis.
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Shanghai Kaibao Tanreqing Injection is listed as a recommended drug for severe and critical diseases of the new crown
Time of Update: 2022-05-27
On March 16, 2022, Shanghai Kaibao issued an announcement stating that the company's product Tanreqing injection was listed as recommended for severe and critical patients during the clinical treatmen
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Boehringer Ingelheim's new immunotherapy drug spesolimab listed in priority review
Time of Update: 2022-05-27
On March 9, the Center for Drug Evaluation (CDE) of the State Drug Administration officially granted Boehringer Ingelheim the first-in-class immunology drug spesolimab (the company's own generic name: spesolimab injection) with priority review and approval Eligibility, the proposed indication is for the treatment of adults with generalized pustular psoriasis (GPP) episodes .
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InnoCare Announces the Acceptance of the New Indication Application for Orelabrutinib in the Treatment of Relapsed/Refractory Waldenström's Macroglobulinemia in China
Time of Update: 2022-05-27
BEIJING, March 14, 2022 /PRNewswire/ -- Nuocheng Jianhua, a high-tech biopharmaceutical company, announced today that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted its Bruton's tyrosine New indication application (sNDA) for the acid kinase (BTK) inhibitor orelabrutinib for the treatment of patients with relapsed/refractory Waldenström macroglobulinemia (WM) .
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Kintor Pharma Announces the First Patient Dosing in the U.S. Phase II Clinical Trial of Furitan for Hair Loss Treatment
Time of Update: 2022-05-27
SUZHOU, March 1, 2022 /PRNewswire/ -- On March 1, 2022, Beijing time, Kintor Pharma announced that its self-developed and potentially the world's first-of-its-kind furitan (KX-826) for the treatment of male androgen The US Phase II clinical trial of alopecia areata (AGA) has completed the first patient enrollment and dosing on February 28, 2022 .
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Chinese pharmaceutical subsidiary Tianfang Co., Ltd. Risedronate Sodium Tablets passed the consistency evaluation
Time of Update: 2022-05-27
On March 10, 2022, Sinopharm announced that its subsidiary Tianfang Co.
Risedronate sodium tablet is a bisphosphonate drug, risedronate sodium has an affinity for hydroxyapatite crystals in bone, is a bone resorption inhibitor, suitable for the treatment and prevention of postmenopausal women.
Osteoporosis .
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Ascletis Anti-COVID-19 Oral Dual Prodrug ASC10 Business Progress
Time of Update: 2022-05-27
Ascletis is committed to the R&D and commercialization of innovative drugs in the fields of viral diseases, nonalcoholic steatohepatitis/primary biliary cholangitis, tumors (oral tumor metabolic checkpoint and immune checkpoint inhibitors), etc.
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Hansoh Pharma's innovative drug revenue will rise by 169% in 2021, deploying ADC and siRNA
Time of Update: 2022-05-26
Clinical application of innovative drug projects of Hansoh Pharma in the past 5 years*Only the first declaration is countedFrom: Insight database project progress module (http://db.
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Simcere Pharma Appoints Danny Chen as Group Senior Vice President
Time of Update: 2022-05-26
On March 28, Simcere announced the appointment of Danny Chen as the senior vice president of the group, responsible for promoting the company's translational science and neurological research and development work, as well as the establishment and management of the Beijing Innovation Center's research and development team to enhance Simcere's capabilities in the field of central nervous system therapy.
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UCB Fintepla Receives FDA Approval for Expanded Indications
Time of Update: 2022-05-26
S. Food and Drug Administration (FDA) has approved the expanded indication of Fintepla (fenfluramine, fenfluramine) for the treatment of patients two years of age and older associated with Lennox-Gastaut syndrome (LGS) of epileptic seizures .
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Former Pfizer COO Wu Kun joins Keixing Pharmaceuticals
Time of Update: 2022-05-26
After taking office, Wu Kun will be based in Shanghai, China and will report to Luo Wanli, CEO of Keixing .
In this role, Wu Kun will be responsible for developing Keixing's commercialization strategy and building a marketing excellence team to drive the commercialization of the company's growing product portfolio .
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Hedging the impact of centralized procurement, Zhongsheng Pharmaceutical has launched 79 new products in the past 5 years
Time of Update: 2022-05-26
The financial report shows that in the past five years, the company has launched 79 new products, and the proportion of revenue has increased to 45.
The annual report shows that the company's innovative drug revenue is 6.
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Hengrui Medicine Gadobutrol Injection obtained drug registration certificate
Time of Update: 2022-05-26
On March 27, Hengrui Pharmaceutical announced that the company received the "Drug Registration Certificate" for gadobutrol injection approved and issued by the State Food and Drug Administration .
38 million yuan has been invested in research and development of gadobutrol injection-related projects .
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Shaanxi: 17 products such as adalimumab and growth hormone have their online prices lowered
Time of Update: 2022-05-26
On March 21, 2022, the Shaanxi Provincial Public Resource Trading Center issued a notice on the dynamic adjustment of drug products listed on the Internet to lower the price .
The online prices of 17 products including docetaxel injection, adalimumab injection, and polyethylene glycol recombinant human growth hormone injection were lowered .
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What clinical data do I need to provide for the first clinical application of an innovative drug?
Time of Update: 2022-05-26
For the organization of CTD general technical documents, on the basis of clinical review, clinical summary, and clinical report, the content can be specific to the development plan (may include Phase I~III), development path, and development time in the clinical trial plan; clinical research plan Dose selection basis (including starting dose, maximum tolerated dose, grouping, dose escalation), blinding (including unblinding, evaluation indicators, subject selection), safety/tolerability evaluation, data analysis, adverse events , ethics, etc.
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WuXi Ju Norici Orenza Injection Approved for Second-Line Treatment of LBCL
Time of Update: 2022-05-26
On March 31, WuXi Junuo announced that its CD19-targeting autologous chimeric antigen receptor T (CAR-T) cell immunotherapy product, Benoda® (Rigiorenza Injection), is used in the second-line treatment of large The pivotal clinical trial application for B-cell lymphoma has been granted implicit approval by the National Medical Products Administration (NMPA) of China .
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Junshi Bio's anti-CD112R monoclonal antibody was approved for clinical use in the United States
Time of Update: 2022-05-26
On April 3, Junshi Bio announced that the company's self-developed anti-CD112R monoclonal antibody injection (project code: TAB009/JS009) has been approved by the US FDA for a clinical trial application for the treatment of advanced solid tumors .
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Vertex's ion channel inhibitor receives Phase 2 clinical proof of concept
Time of Update: 2022-05-26
Vertex Pharmaceuticals today announced positive results from two Phase 2 proof-of-concept clinical trials of its investigational selective NaV1.
References:[1] Vertex Announces Statistically Significant and Clinically Meaningful Results From Two Phase 2 Proof-of-Concept Studies of VX-548 for the Treatment of Acute Pain.
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A new drug for the treatment of hyperammonemia, Kaglutamic acid dispersible tablets, was declared for listing in China
Time of Update: 2022-05-26
According to public information, this is a rare disease treatment product called Carbaglu, which was initially approved overseas for hyperammonemia caused by N-acetylglutamate synthase (NAGS) deficiency .
The enzyme (NAGS) catalyzes the synthesis and is an important allosteric activator of the essential carbamoyl phosphate synthase-1 (CPS-1) in liver mitochondria .
