"Pharmaceutical Express" Baiotai Hong Kong Stock Exchange IPO application to accept the first PrEP drug approved in China.

August 12, 2020 / Medical Information List: FDA Priority Review Qualification Fabri disease innovative therapy is expected to be approved early next year; Daily fresh medicine news, speed reading society and you pay attention to! Part 1 Policy Briefing up-to-date! The National Health and Health Commission meeting to crack down on drug corruption recently, the National Health And Wellness Commission Medical administration and Hospital Administration issued a message that a few days ago, to correct the field of pharmaceutical purchase and sale and medical services in the wrong wind of the 22nd meeting of the inter-ministerial joint meeting held in Beijing.
meeting called for the 2020 anti-wind work to continue to crack down on fraud and fraud to defraud medical insurance funds, consolidate the effectiveness of the drug circulation field, resolutely clean up the industry chaos, actively respond to the epidemic prevention and control risk points, to ensure that all work to achieve effective results.
(National Health And Safety Commission Medical and Medical Administration) the latest punishment standards: pharmacies involved in 5 cases from heavy punishment 11, Chongqing Municipal Drug Administration issued the "Chongqing Municipal Drug Administration Administrative Penalty Discretionary Application Rules (Trial)", on the correct performance of drugs (including drugs, medical equipment, cosmetics, the same between) regulatory duties, to ensure the correct exercise of administrative penalty discretion, in accordance with relevant laws and regulations, formulated new rules.
(Chongqing Municipal Drug Administration) Part 2 After observing that the IPO application of baiotai Hong Kong Stock Exchange was accepted, the company recently submitted to the CSRC on the company's plans to issue foreign-listed foreign shares (H-shares) and listed on the main board of the Hong Kong Stock Exchange, and has received the "China Securities Regulatory Commission administrative license application acceptance document."
(Bai Ottay Announcement) Part 3 Drug Information AMD Gene Therapy Phase 1 results positive administration of 15 months without anti-VEGF rescue injection Adverum recently released new positive interim data for the treatment of wet age-related macular degeneration (wet-AMD) phase I OPTIC research queue 1-4 in glass cavity injection gene therapy.
the study, conducted in patients requiring frequent injections of antivascular endothormic growth factor (VEGF), showed that low-dose and high-dose ADVM-022 single treatment significantly reduced the frequency of annualized anti-VEGF injections.
, in particular, patients with queue 1 who received high doses of single treatment maintained the efficacy of zero anti-VEGF resuscitation injections for more than 15 months.
(Sina Pharmaceutical News) First-line treatment of gastric/esophageal cancer BMS immunocommunication therapy reaches phase 3 clinical endpoint BMS announced, a project called CheckMate-649, designed to evaluate Odivo combined chemotherapy compared to alone chemotherapy Key Phase 3 clinical studies for the first-line therapeutic effect of metastatic gastric cancer, gastroesophageal connecting cancer or esophageal adenocarcinoma patients with PD-L1 expression-positive, i.e. combined positive score of 5, reached the total survival and non-progressive survival of the main study endpoint.
(Drug Mingkangde) auxiliary treatment of postoperative esophageal cancer/gastric cancer patients BMS Odivo reached phase 3 clinical endpoint BMS announced that a phase 3 clinical study called CheckMate-577 reached the primary study endpoint disease-free survival after a pre-planned interim analysis.
study aims to assess the effectiveness of Odevo as an auxiliary treatment for postoperative patients with esophageal cancer and gastroesophageal cancer.
study showed that Odivo patients who underwent new assisted chemotherapy and surgical excision showed significant statistically significant advantages in the main study endpoint DFS compared to placebo, and that different types of patients in the group benefited.
(Pharmaceuticals) is eligible for FDA Priority Review of Fabry Disease Innovation Therapy is expected to be approved early next year Protalix and its partner Chiesi announced today that the FDA has accepted the bioprodone license application for pegunigalasidase-alpha and granted it priority review eligibility for adult Fabri disease patients.
expects the FDA to respond by January 27, 2021.
(Drug Mingkangde) treatment of platinum-resistant ovarian cancer New ADC drug was approved by the FDA fast-track local time on the 11th, Mersana announced that its antibody conceding drug (ADCs) XMT-1536 was awarded fast-track qualification by the U.S. FDA for the treatment of platinum-resistant high-level slurry ovarian cancer.
these patients are platinum resistant and have received three pre-systemic treatments, or four advance systemic treatments regardless of platinum resistance.
(Sina Pharmaceutical News) The country's first PrEP drug was approved for HIV pre-exposure pro- and pre-exposure pro- and pre-exposure prosthetics on the 11th, Gilead announced that Shufatai ® has been approved by the State Drug Administration for combining safe sexual behavior measures to conduct pre-exposure pro-pre-exposure prosthetic (PrEP) to reduce the risk of HIV-1 in adults and adolescents (weighing at least 35 kg or more) through high-risk sexual behavior.
(Sina Pharmaceutical News) Xindili single-line treatment of squamous non-small cell lung cancer listing application by NMPA to accept Cinda Bio and Lilly jointly announced: NMPA has officially accepted the two sides jointly developed innovative PD-1 inhibitor Dabershu® (Xindili monoanti-injection) combined with Gixitabin for the first-line treatment of squamous non-small cell lung cancer new adaptation application.
, NMPA formally accepted a new adaptation application for non-scaly NSCLC first-line treatment on 23 April 2020 from Dabershu® (Syndili monoantigen injection).
(Now) Pfizer PD-1 inhibitors approved in China clinical CDE website recently showed that Pf-Ray's PD-1 inhibitor PF-06801591 injection in China obtained a clinical trial implied license, adaptive to "high-risk non-muscle immersive bladder cancer."
, PF-06801591 has entered phase 3 clinical development, the first time the drug has been approved clinically in China.
(CDE) Wenda Pharmaceutical BET inhibitors approved clinical CDE website latest data, by Wenda Pharmaceuticals and Hengya Pharmaceuticals jointly declared a class of 1 innovative drug NHWD-870 HCl tablets in China obtained two clinical implied licenses, proposed to develop for the treatment of late-stage recurrence of non-Hodgkin's lymphoma, skin/mucosal melanoma, non-small cell lung cancer and small cell lung cancer.
NHWD-870 is a new, powerful BET inhibitor to be developed for the treatment of multiple solid tumors.
(CDE) the first neurotrophic corneitis drug will soon be approved in China Domp? in China to submit the Cenegermin eye drops market application to enter the administrative approval stage, is expected to be approved in the near future for the treatment of neurotrophic cornealitis.
neurotrophic cornealitis is a rare disease of corneal epithelral healing disorders.
it is characterized by percepta percepta culture damage, the formation of a large area of corneal epithal loss and ulcers, ulcers progress seriously can cause corneal perforation.
(Pharmaceutical Rubik's Cube) 1.7 billion injection varieties This Shanxi pharmaceutical company will be the first to review recently, Abao Pharmaceuticals according to the imitation of 4 categories of reported sulfuric acid injection registration status changed to "in the approval", is expected to be approved in recent days and the first review.
thioic acid injections are used for diabetes, and sales of end-use thioic acid injections in public medical institutions in China exceeded 1.7 billion yuan in 2019.
(Minernet) No. and Nord actively suspended 2 new drug development projects in the study of obesity recently, No. Nord released Q2 performance report shows that the company terminated the development of two new drug research projects, involving a glutatrogen / GLP-1 receptor co-excitement and a GLP-1, gastric inhibitor peptides and glutatrogin receptor triple complete agitator, both drugs in the study of obese.
(CPhI Pharmaceuticals Online)