Research and development daily Junshi bioPD-1 single anti-phase 3 clinical reached the main research endpoint.

2020.09.29 Research and Development NEWS: Roche oral SMA therapy has a positive long-term effect; Pfizer XELJANZ has been approved for the fourth allergy in the United States; the FDA has granted AbbVie ezanumab orphan drugs and fast-track qualifications; and Kantai Biovirus Inactivated Vaccine (Vero cells) has been approved for clinical trials... 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, can read the original text) "Drug Research and Development" Junshi bioPD-1 single anti-phase 3 clinical reached the main research endpoint 28, Junshi Bio announced that the company's independent research and development of anti-PD-1 single Randomized, double-blind, placebo-controlled, and international multi-center Phase 3 clinical studies for the treatment of relapsed or metastatic nasopharyngeal cancer with anti-Ripley mono-anti-combination chemotherapy were determined by the Independent Data Monitoring Committee to have reached the preset main research endpoint.
Plans to submit a listing application to the State Drug Administration and the drug regulatory departments of relevant countries in the near future.
Roche oral SMA therapy with positive long-term efficacy Roche's gene Tektronia announced that its innovative spinal muscular dystrophy (SMA) therapy Evrysdi, in the treatment of symptomatic SMA infants (age 2-7 months) in the FIREFISH study, obtained positive 2 years of trial results.
infants receiving the treatment dose Evrysdi, 80.9% of patients continued to improve their symptoms and reached exercise milestones.
Evrysdi was approved by the FDA in August to become the first oral therapy to treat SMA patients.
Sarepta published positive clinical results for gene therapy SRP-9001 and SRP-9003 positive data Sarepta recently announced two gene therapy SRP-9001 and SRP-9003.
SRP-9001 is a gene therapy for Duchy muscular dystrophy, and over a 2-year period, all patients were well resistant to SRP-9001.
all adverse events are mild or moderate and occur within 90 days of treatment.
no serious adverse events or signs of complement activation.
SRP-9003 is a gene therapy for the treatment of muscular dystrophy type 2E, the results showed that after infusion of SRP-9003 in two dose groups, effective transductivity of skeletal muscle and expression of β-myosin were observed, and creatinase was significantly reduced during 90 days of treatment.
(Drug Approval) Pfizer XELJANZ approved the fourth adaptive disease in the United States on the 28th, Pfizer announced that the U.S. FDA approved XELJANZ® for the treatment of active multi-joint disease in adolescents with idiopathic arthritis 2 years of age and older children and adolescents.
has previously been approved in the United States for three types of adaptive disorders: moderate to severe active RA patients after failure to use methotrexate; adult patients with active psoriasis arthritis after failure to use anti-rheumatoid drugs; and adult patients with moderate to severe active colitis after failure with tumor necrosis agent inhibitors.
The U.S. FDA granted AbbVielezanumab orphan drug and fast-track qualification AbbVie recently announced that the U.S. FDA has granted elezanumab orphan drug qualification and fast-track qualification, a treatment for patients with spinal cord injury in the study.
elezanumab is a human immunoglobulin G1 monoclonal antibody that selectively binds to the repulsive guide molecule A.
.S. FDA has approved Haegarda Enlarged Adaptation as a routine preventive treatment for the prevention of hereditary angioedema (HAE) episodes in patients 6 years of age and older, the FDA has approved.
Haegarda reduces HAE seizures by 95%, making the drug the first and only off-skin treatment for patients 6 years and older to prevent HAE seizures.
addition to expanding pediatric adaptations, the updated label includes clinical safety data on the use of Haegarda by pregnant women.
the European Union approved Zynrelef, a new non-opioid double-acting painkiller, and Heron announced recently that the European Commission has approved Zynrelef for the treatment of postoperative pain caused by small and medium-sized surgical wounds in adults.
Zynrelef is a new, non-opioid painkiller, a dual-acting, fixed-dose combination of local anaesthetic bubikain and low-dose nonsteroidal anti-inflammatory drug meloxicon, designed to treat pain and inflammation after a single dose at the surgical site.
new coronavirus inactivated vaccine (Vero cells) approved clinical trials Kantai Bio issued a notice, recently received the State Drug Administration issued a drug clinical trial approval.
: After review and review by a special expert group, the new coronavirus inactivated vaccine (Vero cells) was approved for clinical trials, and the adaptation was used to prevent new coronavirus pneumonia caused by SARS-CoV-2 infection.
Rohin obtained acetic acid abitorone tablets market application acceptance notice 28, Luoxin Pharmaceuticals issued a notice that subsidiary Shanghai Luoxin as MSN LABORATORIES PRIVATELIMITED in China registered agency to declare the listing application for acetic acid acetic acid abphetron tablets received the "receiving notice" issued by the State Drug Administration.
announcement shows that acetic acid a bittron tablets are the first overseas-listed drug applications introduced by Luoxin Pharmaceuticals through international cooperation to list projects in China, compared with the local imitation development, with a short market cycle, low cost and other advantages.
Heyikang Pharmaceuticals benzoic acid left ammonia chloride tablets will soon be approved, Hebei Ren heiYikang Pharmaceuticals to imitate the 4 categories of submitted benzodialyc chloride tablets to enter the administrative approval stage, will be approved in recent days.
Benzene sulfonate L-Achloride is a calcium ion antagonist-type antitrophic drug, for benzodiacycline chlorine-leveling L-spinner, retaining the anti-hypertension effect at the same time can reduce edema and other side effects.
(Minenet) Hengrui Pharmaceutical "Grom bromine ammonium injection" was the first approved 28, Hengrui Pharmaceutical 3 classes of generic drug Grombromide injection was officially approved by the State Drug Administration listed, becoming the first Glon ammonium bromide injection approved manufacturers.
Zhengda Qing "Kaglie Net Tablet" was approved for listing on the 28th, Zhengda Tianqing 4 classes of generic drug Kagli net tablets were approved by NMPA for listing, becoming the second domestic generic drug listed enterprises after Howson Pharmaceuticals.
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