Research and development daily liver cancer major breakthrough! Roche Tecentriq and Avastin Japan were approved.

2020.10.09 Research and Development NEWS: Amjin omecamtiv mecarbi Phase III trial reached the main endpoint but did not extend the life of patients; Mercadon 2DR first-line treatment of HIV Phase 2b clinical efficacy comparable to the compound drug Delstrigo; GSk/Vir Biotechnology and antibody treatment early COVID-19 into Phase III stage; Roche Tecentriq and Avastin Japan were approved... We focus on the latest developments in pharmaceutical research and development, to provide research and development personnel with timely and accurate information reference.
(click on the title, read the original) "Drug Research and Development" Mercadon 2DR first-line treatment of HIV Phase 2b clinical efficacy comparable to the compound drug Delstrigo 8, Mercadon announced the evaluation of new oral nucleoside reverse transcriptase Transposing inhibitors (NRTTI) islatravir and Pifeltro (doravirine, doravirine) two-drug program (2DR) treated with 96 weeks of trials of stage 2b in adults with HIV-1.
results show that this 2DR is similar to the three-in-one drug Delstrigo (doravirine/3TC/TDF) in maintaining virological inhibition (HIV-1 RNA<50 copy/ml).
The phase 3 study of the heart failure drug omecamtiv mecarbil, developed jointly by Amjin and Cytokinetics, showed that it reached the end of the trial in reducing the risk of hospitalization and other emergency treatment for patients with chronic heart failure, but the drug failed to help patients live longer in the trial.
recently, Amgen announced that its KRAS G12C inhibitor sotorasib (AMG 510) was used to treat 126 patients with advanced non-small cell lung cancer (NSCLC) who tested positive for the top line of Phase II CodeBreaK 100 clinical trials in which they had previously received immunotherapy and/or chemotherapy.
results showed that Sotorasib's objective response rate was consistent with previously reported Phase I clinical (960 mg/day dose group treatment of late NSCLC) data and reached the main endpoint.
Ain announced a five-year open label study: Aimovig Therapeutics EM has long-term efficacy and safety Amjin recently released data to evaluate the long-term safety and efficacy of the five-year open label treatment period in adult patients with episodic migraine (EPIsodic migraine, EM) treatment of migraines.
results show that Aimovig not only helps patients continuously reduce the number of migraine days per month, but also reduces the use of acute migraine-specific drugs (AMSMs, such as triptans).
, safety was consistent with the results observed during the double-blind treatment period of the study.
Pfizer's phase III study of long-acting human growth hormone therapy once a week for children between the ages of 3 and 18 was successful, Pfizer/OPKO Health announced the success of a phase III study that evaluated the randomization, open labeling, cross-medication, and Phase III C0311002 injections of somatrogon once a week in pediatric patients aged 3 to 18 years of age.
top-line data showed that after 12 weeks of treatment, the average overall life intervention score of patients in the one-injection-a-week somatrogon group was significantly lower than in the one-injection-a-day somatropin group (8.63 vs. 24.13), significantly improving the patient's treatment burden.
Days before the early COVID-19 phase III of
GSk/Vir Biotechnology's antibody therapy entered Phase III, Vir Biotechnology/GSk announced that the VIR-7831 (GSK4182136) treatment of early COVID-ICE studies for patients with a higher risk of hospitalization will be extended to phase III globally and will be integrated into more centers in North America, South America and Europe.
"Drug Approval" liver cancer first-line treatment major breakthrough! Roche Tecentriq-Avastin Japan approved Roche-controlled Japanese pharmaceutical company Sino-foreign pharmaceutical company recently announced that Japan's Ministry of Health, Labour and Industry has approved anti-PD-L1 therapy Tecentriq (Tai Sanqi, generic name: atezolizumab, atili pearl monoanti) joint Avastin (Avetin, generic name: beizvacumab, beva bead monoantigen) for the treatment of previously unsecondable liver cancer patients.
Japan has approved the regulatory approval of JYSELECA® (Non-Gottini) for the treatment of rheumatoid arthritis Gilead and Eyre, japan's Ministry of Health, Labour and Industry has granted regulatory approval for Jyseleca® (non-Gotini 200mg and 100mg tablets).
Jyseleca® is a daily oral JAK1 preferred inhibitor used to treat rheumatoid arthritis in patients who are underreact to conventional therapies, including the prevention of structural joint injuries.
AstraZeneta has announced that it has awarded Farxiga (Daglie Net) breakthrough therapy for the treatment of patients with chronic kidney disease, regardless of whether they are associated with type 2 diabetes.
days before hengrui pharmaceutical SGLT-2 inhibitor "Heng gree net" was declared for listing, CDE official website showed that Hengrui pharmaceutical submitted a new class of drug proline hengle net tablets listed application was accepted.
is the first domestic SGLT-2 inhibitor to be declared on the domestic market.
a new drug for rare diseases! Pfizer's "chlorobenzene softgels" were approved in China on september 9, Pfizer submitted in China for the listing of chlorobenzene softgels approved by the State Drug Administration for the treatment of adult wild or genetic thyroxine protein amyloid degenerative cardiomyopathy (ATTR-CM) to reduce cardiovascular death and cardiovascular-related hospitalization.
BioNTech/Pfizer submitted a rolling application for coVID-19 vaccine to the European Union, Pfizer/BioNTech announced that it had submitted a rolling application for COVID-19 vaccine BNT162b2 to the European Medicines Agency (EMA), which has accepted the application and the Human Medicines Commission (CHMP) has initiated a rolling review.
, the EMA announced on October 1st that it had launched a rolling review of the ASIL/Oxford COVID-19 vaccine AZD1222.
Confang bioPD-1/CTLA-4 dual resistance is intended to be included in the breakthrough treatment varieties 9, CDE website again updated the list of breakthrough therapeutic drugs, the new varieties for Kangfang biological PD-1/CTLA-4 double anti-AK104 injection.
FDA granted IMGN632 breakthrough drug qualification for the treatment of rare blood tumors, ImmunoGen corporation announced recently, the U.S. FDA has awarded the new CD123 targeted ADC therapy IMGN632 breakthrough drug qualification (BTD) for the treatment of patients with relapsed or refractic maternal plasma cell-like dendrites (BPDCN).
Assas Pharmaceutical Apoptosis Pipeline made further progress on the 9th, AXA Pharmaceuticals announced that the U.S. FDA has awarded the company apoptosis pipeline in the original innovative drug MDM2-p53 inhibitor APG-115, Bcl-2/Bcl-xL inhibitor APG-1252 two orphan drugs for the treatment of acute myeloid leukemia, small cell lung cancer.
, as of now, assassin Pharmaceuticals has obtained 6 FDA orphan drug qualifications in the research of new drugs.
the launch of Bluebird's breakthrough gene therapy Lenti-D, Bluebird announced that the European Medicines Agency (EMA) had formally accepted a listing application for its gene therapy elivaldogene autotemcel (Lenti-D™, Eli-cel) for the treatment of brain-type adrenal whiteness malnutrition.
July, Lenti-D entered the EMA's Human Medicines Board (CHMP) accelerated review channel, reducing the approval cycle for its EU listing applications from 210 to 150 days.
bluebird plans to file a Lenti-D listing application with the FDA in mid-2021.
won the U.S. EUA! Drug Testing in partnership with Seymru and Mayo Clinic to help the global fight against the epidemic 8, Shanghai Pharmaceuticals announced that the new coronavirus anti-medical test kit developed in cooperation with Seymru Andy and Mayo Clinic - Thermo Scientific OmniPath COVID-19 Total Antibody ELISA, obtained the FDA Emergency Use Authorization (EUA), and the United States and European plants in Seymexico put into production.
's world's first CLDN18.2 CAR-T cell drug has been awarded the "orphan drug" title by the FDA Kozi Bio recently announced that the U.S. FDA has awarded its target Claudin 18.2 self-embedded antigen-binding antigen-cell (CLDN18.2 CAR-T) "orphan drug" title for the treatment of stomach adenocarcinoma and esophageal gastric conjups adenocarcinoma.
3 injections were approved today as if through the consistency evaluation 9, 3 injections approved by the State Drug Administration listed and as approved by the consistency evaluation, respectively: Jiangsu PCCW Biopharmaceutical propofol in / long-chain fat emulsion injection, Puli Pharmaceutical injection with bivaledin and Jiangsu Duri Pharmaceutical injection with methionate mosta.
Notay Bio "Aglitin tablets benzoic acid tablets" approved the fourth domestic today, NMPA issued approval shows that The Notay bio-4 generic drug "agritin tablets benzoic acid" was approved, the fourth domestic.
Haisco "Pepperi Statin tablets" the first review of 9, NMPA issued approval shows that Hesco 4 classes of generic drugs "Pepperpuristamin tablets" was approved for listing, becoming the second domestic approval of the variety, at the same time as through consistent evaluation, became the first review.
(Research and Development Cooperation) Takeda has reached a research and development cooperation agreement to develop potential "first-in-class" RNAi therapies, Takeda and Arrowhead Pharmaceuticals announced today that they will jointly develop a potential "first-in-class" RNAi therapy ARO-ATT for the treatment of α-1 antitase-related liver disease (AATLD).
ARO-AAT is designed to reduce the α-1 antitrotein protein, which is the root cause of the progression of AATLD disease.
Sinda/Lilly's cooperation with Dabershu expanded through the U.S. HSR Act Waiting Period Agreement officially entered into force Xinhua Bio 7 announced on August 18, 2020 the company and Lilly Pharmaceuticals signed an expanded global strategic cooperation on Dabershu ® (Hindili single anti-injection) has passed the United States Hart-Scott-Rodino ("HSR") Act waiting period.
all the conditions for this cooperation agreement are in place and the transaction is in force.
BioAtla/Baiji Shenzhou Revised Global Development and Commercialization Agreement for BA3071 BioAtla/Baiji Shenzhou has announced a revised Agreement to amend the Global Joint Development and Commercialization Agreement signed by BioAtla in April 2019 for CAB CTLA-4 Antibody BA3071, which is now a GLOBAL license agreement for BA3071.
under the terms of the revised agreement, Baji Shenzhou will have a global exclusive license to BA3071 and will be solely responsible for its clinical development and commercialization worldwide, as well as the right to receive full profits from future sales of the products.
addition to the advances under the original agreement, BioAtla will also be eligible for recent development and pharmaceutical milestone payments and revised and increased global sales tiered royalties.
terms of the revised agreement have not been disclosed.
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