The fourth batch of "Pharmaceutical Speed ​​Reading Society" landed in Xinda PD-1 and the third indication will...

[May 31, 2021/Medical Information List] Johnson & Johnson's Erleada combined with ADT Therapy Phase 3 clinical trial has significant results; first-line squamous NSCLC! Cinda PD-1 on three indications about to be granted; core Electronics Co.

[May 31, 2021/Medical Information List] Daily fresh medicines and medical news, speed reading and follow you together!

Part 1 Policy Brief

Part 1 Policy Briefing Part 1 Policy Briefing

State Food and Drug Administration: Guangzhou Aixinda Electronics Co.

State Food and Drug Administration: Guangzhou Aixinda Electronics Co.

Announcement of the State Food and Drug Administration on updating the list of banned cosmetics

Announcement of the State Food and Drug Administration on updating the list of banned cosmetics

On the 28th, the State Food and Drug Administration issued the “Announcement of the State Food and Drug Administration on Updating the List of Prohibited Raw Materials for Cosmetics (No.

The fourth batch of centralized procurement has been implemented in 31 provinces and cities across the country

The fourth batch of centralized procurement has been implemented in 31 provinces and cities across the country

On the 29th, Beijing’s fourth batch of national procurement winning bid results were fully implemented in the city.

Part 2 Observation of Sankei

Part 2 Sankei Observation Part 2 Sankei Observation

Children of 1.

Children of 1.

Part 3 Drug News

Part 3 Drug News Part 3 Drug News Information

Johnson & Johnson's Erleada combined with ADT Therapy Phase 3 clinical trial has significant results

Johnson & Johnson's Erleada combined with ADT Therapy Phase 3 clinical trial has significant results

According to the latest data from Johnson & Johnson's Erleada trial, patients with metastatic castration-sensitive prostate cancer are less likely to die after receiving Erleada treatment, and their quality of life can be maintained.

Subcutaneous injection of PD-L1 antibody Phase 1 clinical data published in the United States

Subcutaneous injection of PD-L1 antibody Phase 1 clinical data published in the United States

News on the 28th, a recombinant humanized PD-L1 single-domain antibody (Envolimab, KN035) strategically cooperated by Corning Jerry, Sidi Medicine, and Simcere Pharmaceuticals.

Expected to benefit 95% of migraine patients with oral CGRP receptor inhibitors approved for extended indications

Expected to benefit 95% of migraine patients with oral CGRP receptor inhibitors approved for extended indications

Biohaven Pharmaceuticals announced that the US FDA has approved its small molecule CGRP receptor inhibitor Nurtec orally disintegrating tablets for extended indications for the preventive treatment of paroxysmal migraine.

Yingli Pharmaceutical's PI3Kδ inhibitor has obtained three FDA orphan drug qualifications

Yingli Pharmaceutical's PI3Kδ inhibitor has obtained three FDA orphan drug qualifications

On the 28th, Yingli Pharmaceuticals announced that the U.

Rituximab "upgraded version"! Roche's second-generation CD20 monoclonal antibody is about to be approved

Rituximab "upgraded version"! Roche's second-generation CD20 monoclonal antibody is about to be approved

Insight intelligence monitoring system shows that Roche's second-generation CD20 monoclonal antibody Obinutuzumab (Otuzumab, trade name Gazyva®) has entered the administrative approval stage and is expected to be approved in the near future.

A line of squamous NSCLC! Cinda PD-1's third indication will be approved soon

A line of squamous NSCLC! Cinda PD-1's third indication will be approved soon

According to the official website of NMPA, the listing application for new indications of Sintilimab (acceptance number: CXSS2000043) has entered the "under approval" status and is expected to be approved in the near future.

Yangtze River's Class 1 new drug "Levoornidazole Disodium Phosphate for Injection" approved for marketing

Yangtze River's Class 1 new drug "Levoornidazole Disodium Phosphate for Injection" approved for marketing

According to the official website of NMPA, Yangzijiang Pharmaceutical's Class 1 new drug "Levoornidazole Phosphate Disodium for Injection" (acceptance number: CXHS1900022) has been approved for marketing.

Zejing Pharmaceutical's Class 1 new drug ``Donafinil Tosylate Tablets'' will soon be approved for advanced hepatocellular carcinoma

Zejing Pharmaceutical's Class 1 new drug ``Donafinil Tosylate Tablets'' will soon be approved for advanced hepatocellular carcinoma

On the 31st, the NMPA official website showed that Zejing Pharmaceutical’s Class 1 new drug "Donafinil Tosylate Tablets" has completed the market review and entered the approval status.

Microchip Bio: Sigglita Sodium Tablets Obtained Clinical Trial Notice

Microchip Bio: Sigglita Sodium Tablets Obtained Clinical Trial Notice

Microchip said that its wholly-owned subsidiary has recently received a "Clinical Trial Notice" issued by the State Food and Drug Administration.

KRAS inhibitor! Jiaxian Pharmaceutical's anti-tumor Class 1 new drug was approved for clinical use in China

KRAS inhibitor! Jiaxian Pharmaceutical's anti-tumor Class 1 new drug was approved for clinical use in China

Jacos Pharmaceuticals recently announced that its research project, the KRAS G12C inhibitor JAB-21822, was approved for clinical use in China on May 27 following its recent clinical approval in the United States.
According to the press release, Jacos Pharmaceuticals will start multi-center clinical trials for tumor patients with non-small cell lung cancer, colorectal cancer and other solid tumors in China and the United States, and plan to start patient enrollment in the second half of 2021.
(WuXi AppTec)

First imitation! Hengrui Medicine's "Azilsartan Tablets" will be approved soon

First imitation! Hengrui Medicine's "Azilsartan Tablets" will be approved soon

Insight intelligence monitoring system shows that the listing application of Hengrui's class 3 generic drug "Azilsartan Tablets" is "under review" (acceptance number: CYHS1700171, CYHS1700170).
The review process has gone through two rounds of supplementary information and clinical trial on-site verification.
It is expected to be approved soon.
According to the new registration classification of chemical drugs, the three types of applications will be deemed to have passed the consistency evaluation after approval.
(Insight database)

Hengrui Medicine: Review of Caspofungin Acetate for Injection

Hengrui Medicine: Review of Caspofungin Acetate for Injection

Hengrui Medicine stated that it has recently received the "Drug Supplementary Application Approval Notice" on caspofungin acetate for injection approved and issued by the State Food and Drug Administration.
The company caspofungin acetate for injection has passed the generic drug quality and efficacy consistency evaluation .
(a)

Hausen "Erlotinib Hydrochloride Tablets" Approved for Listing

Hausen "Erlotinib Hydrochloride Tablets" Approved for Listing

On the 31st, Hausen’s "Erlotinib Hydrochloride Tablets" was approved by the State Food and Drug Administration and became the second domestic generic drug of this variety.
Erlotinib is the first-generation EGFR inhibitor and was approved by the FDA as early as 2004 for the treatment of locally advanced or metastatic NSCLC after at least one chemotherapy failure.
(Insight database)

Jiudian Pharmaceutical: Ornidazole tablets passed the consistency evaluation of generic drugs

Jiudian Pharmaceutical: Ornidazole tablets passed the consistency evaluation of generic drugs

On the 31st, Hunan Jiudian Pharmaceutical stated that ornidazole tablets passed the consistency evaluation of the quality and efficacy of generic drugs.
As of the date of this announcement, Jiudian Pharmaceutical is one of the three domestic companies that have passed the consistency evaluation of ornidazole tablets.
(a)

Tianyao: Methylprednisolone sodium succinate for injection passed the consistency evaluation

Tianyao: Methylprednisolone sodium succinate for injection passed the consistency evaluation

Tianyao said that its subsidiary Tianjin Jinyao Pharmaceutical Co.
, Ltd.
received the "Drug Supplementary Application Approval Notice" on methylprednisolone sodium succinate for injection approved and issued by the State Food and Drug Administration, and approved the drug to pass the quality of generic drugs.
And evaluation of consistency of efficacy.
(a)