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[June 11, 2021/Medical Information List] Renyue Pharmaceutical did not recall the drug within the specified time and was punished; the procurement of orthopedic consumables began; Bristol-Myers Squibb CAR-T therapy reached the phase 3 clinical primary end point; Come and cooperate with ALX to develop a combination therapy for gastric cancer/gastric junction cancer.
[June 11, 2021/Medical Information List] Daily fresh medicines and medical news, speed reading and you will pay attention together!
Part1 Policy Brief
Part1 policy briefing Part1 policy briefingAnnouncement of the State Food and Drug Administration: 16 batches of drugs are unqualified
Announcement of the State Food and Drug Administration: 16 batches of drugs are unqualifiedOn the 10th, NMPA issued a notice that 16 batches of drugs did not meet the requirements
The purchase of orthopedic consumables has begun
The purchase of orthopedic consumables has begunOn the 9th, the Anhui Provincial Medical Centralized Procurement Service Center publicly solicited opinions from the public on the "Anhui Province Orthopedics Spine Implants Centralized Procurement Documents" and the "Announcement on Carrying out Anhui Province Ophthalmic Intraocular Lens Procurement Work"
Part2 Observation
Part2 Sankei Observation Part2 Sankei ObservationSynthekine receives US$107.
Synthekine receives US$107.
Small cell factor therapy company Bright Peak complete the $ 107 million B round of financing
Small cell factor therapy company Bright Peak complete the $ 107 million B round of financingOn the 10th, the biotechnology company Bright Peak Therapeutics announced that it has raised US$107 million in Series B financing
Shanghai Ruikang Biotechnology completes Series A financing
Shanghai Ruikang Biotechnology completes Series A financingShanghai Ruikang Biotechnology recently announced the completion of a series A financing of hundreds of millions of yuan.
Juhe Biotechnology completed nearly 100 million yuan of Pre-A round of financing, focusing on early screening and early diagnosis of gynecological tumors
Juhe Biotechnology completed nearly 100 million yuan of Pre-A round of financing, focusing on early screening and early diagnosis of gynecological tumorsJuhe Biotechnology announced the completion of a Pre-A round of financing of nearly 100 million yuan, led by Shanlan Capital, followed by well-known industrial institutions, and Probe Capital as the exclusive financial advisor
Mental health services company LifeStance Health listed on Nasdaq
Mental health services company LifeStance Health listed on NasdaqOn June 10th, local time, the American mental health service company LifeStance Health Group.
Renyue Pharmaceutical was punished for failing to recall drugs within the specified time
Renyue Pharmaceutical was punished for failing to recall drugs within the specified timeOn the 9th, the Hubei Provincial Food and Drug Administration released a piece of administrative punishment information.
3 FDA expert team members resigned due to Bojian Aduhelm's approval
3 FDA expert team members resigned due to Bojian Aduhelm's approvalOn the 7th, Biogen's new Alzheimer's disease drug Aduhelm was approved by the US FDA for marketing
Part3 Medicine News
Part3 Medicine News Part3 Medicine NewsMerck launches two new anti-HIV drugs, Destro and Pedro in China
Merck launches two new anti-HIV drugs, Destro and Pedro in ChinaMerck announced today that its daily single-tablet compound preparation Destro, and daily single-table single-drug preparation Pedro were officially launched in China
Astella's prostate cancer drug Xtandi is approved by NICE in the UK
Astella's prostate cancer drug Xtandi is approved by NICE in the UKA few days ago, the British NICE decided to recommend the once-a-day oral drug Xtandi, combined with standard androgen deprivation therapy, to treat patients with metastatic hormone-sensitive prostate cancer
Luye Pharma’s new antidepressant drug Ansufaxine Hydrochloride Sustained-Release Tablets was accepted by CDE
Luye Pharma’s new antidepressant drug Ansufaxine Hydrochloride Sustained-Release Tablets was accepted by CDEOn the 10th, Luye Pharmaceutical Group announced that its self-developed Chinese chemical drug class 1 new drug Ansufaxine Hydrochloride Sustained-Release Tablets has been officially accepted by the Drug Evaluation Center of the China National Medical Products Administration
Puluo Pharmaceutical: Ceftazidime for injection passed the consistency evaluation of generic drugs
Puluo Pharmaceutical: Ceftazidime for injection passed the consistency evaluation of generic drugsOn the 11th, Prologue Pharmaceuticals stated that its wholly-owned subsidiary, Zhejiang Jutai Pharmaceutical Co.
Qinhao Pharmaceutical obtained the first IND approval in China
Qinhao Pharmaceutical obtained the first IND approval in ChinaThe latest announcement by CDE shows that Qin Hao Medicine's Class 1 new drug GH35 tablets has been approved by two clinical trials, and the indication is advanced solid tumors
Bristol-Myers Squibb CAR-T Therapy Reached Phase 3 Primary Endpoint
Bristol-Myers Squibb CAR-T Therapy Reached Phase 3 Primary Endpoint
Bristol-Myers Squibb Company today announced that its CD19-targeted CAR-T cell therapy Breyanzi reached the primary and key secondary endpoints in a phase 3 clinical trial.
Compared with standard treatment, it significantly improved relapsed/refractory large B cells Event-free survival, complete remission rate and progression-free survival of patients with lymphoma
.
(WuXi AppTec)
Bristol-Myers Squibb "O+Y" combination shows overall survival benefit in patients with esophageal cancer
Bristol-Myers Squibb "O+Y" combination shows overall survival benefit in patients with esophageal cancer
Recently, foreign media reported that Bristol-Myers Squibb's immunotherapy Opdivo, when used in combination with chemotherapy or Yervoy, showed a significant overall survival benefit in patients with advanced/metastatic esophageal cancer
.
Interim analysis data from the Phase III CheckMate-648 trial showed that for patients with advanced/metastatic esophageal cancer expressing PD-L1, the median OS of Opdivo combined with chemotherapy was 15.
4 months, while the median OS of chemotherapy alone was 9.
1 months
.
(Sina Pharmaceutical News)
Zejing Pharmaceutical's JAK inhibitor phase 2 clinical success
Zejing Pharmaceutical's JAK inhibitor phase 2 clinical success
On the 11th, Zejing Pharmaceutical issued an announcement stating that the Phase 2 clinical study of its new class 1 drug Jectinib Hydrochloride Tablets in the treatment of moderate and high-risk myelofibrosis has been successful, and it was selected as an oral report at the 2021 European Society of Hematology Annual Meeting
.
The results showed that the ratio of SVR35 in the 100mg BID group and 200mg QD group was 51.
9% (27/52) and 30.
8% (16/52), respectively, after treatment with Jacketinib hydrochloride tablets for 24 weeks.
The difference between the groups was statistically significant.
The group was significantly better than the 200mg QD group
.
(a)
Longyu Pharmaceutical Cavosonstat in the treatment of moderate to severe asthma in China and the U.
S.
Phase II clinical trial launched
S.
Phase II clinical trial launched
On the 11th, Longyu Pharmaceutical announced that the Phase II clinical trial of Cavosonstat, a new class I drug developed by it for the treatment of moderate to severe asthma, was officially launched
.
Among them, the United States is cooperating with the precise institution funded by the National Institutes of Health.
The recruitment of patients has begun and the first drug will be administered soon.
At the same time, it is planned to establish a clinical research center in the United Kingdom
.
The Chinese side is independently carried out by Langyu Pharmaceuticals.
The clinical phase I bridging trial has been completed a few days ago, and the phase II clinical trial is about to start
.
In the phase I clinical trial, Cavosonstat showed good safety.
The maximum single-day administration dose could reach 1600mg.
During the trial, no SAE occurred, no dose-dependent toxicity was found, and all AEs were mild
.
(a)
Eli Lilly and ALX Collaboration: Development of Combination Therapy for Gastric Cancer/Gastroesophageal Junction Cancer
Eli Lilly and ALX Collaboration: Development of Combination Therapy for Gastric Cancer/Gastroesophageal Junction Cancer
On the 10th, ALX Oncology and Eli Lilly signed a clinical trial cooperation and supply agreement to evaluate the combination therapy of ALX148 and Cyramza for the treatment of patients with HER2-positive gastric cancer or gastroesophageal junction cancer
.
ALX148 is a next-generation CD47 checkpoint inhibitor, and Cyramza is an anti-VEGFR2 antibody
.
(Sina Pharmaceutical News)
