"Pharmaceutical Speed ​​Reading Society" Novartis iptacopan treats IgA nephropathy stage 2 clinical...

[June 7, 2021 / List of medical information] CDE high-profile escort gene therapy products; Kangli Medical completed nearly 100 million yuan of Pre-B round of financing; Xinlitai hypertension drug allisartan medoxomil and indapamide sustained-release tablets approved Clinical; Samsung Pharmaceuticals and GemVax submit the results of the new drug Phase III trial.

Part1 Policy Brief

Part1 policy briefing Part1 policy briefing

Long-term follow-up clinical guidelines plan to release CDE high-profile escort gene therapy products

Long-term follow-up clinical guidelines plan to release CDE high-profile escort gene therapy products

The official website of CDE released the "Technical Guidelines for Long-term Follow-up Clinical Research of Gene Therapy Products (Draft for Comment)", and the deadline is July 4, 2021

Part2 Observation

Part2 Sankei Observation Part2 Sankei Observation

100 times more sensitive than existing liquid biopsy technology, cutting-edge A round of financing of $12.

100 times more sensitive than existing liquid biopsy technology, cutting-edge A round of financing of $12.

Kangli Medical completed nearly 100 million yuan of Pre-B round of financing

Kangli Medical completed nearly 100 million yuan of Pre-B round of financing

Recently, Kangli Medical announced the completion of a Pre-B round of financing of nearly 100 million yuan, led by Yuhong Capital

Zhongke Ruiyi completes angel round financing

Zhongke Ruiyi completes angel round financing

Zhongke Ruiyi recently completed an angel round of financing, jointly led by Lenovo Ventures and Zhen Fund, and common investment co-investments.

Part3 Medicine News

Part3 Medicine News Part3 Medicine News

Roche presents new data on CD20xCD3 T cell binding bispecific antibody NHL immunotherapy

Roche presents new data on CD20xCD3 T cell binding bispecific antibody NHL immunotherapy

Recently, according to foreign media reports, Roche Genentech demonstrated its research CD20xCD3 T cell binding bispecific antibodies mosunetuzumab and glofitamab, and its first CD79b antibody drug conjugate Polivy (polatuzumab vedotin) at the ASCO 2021 annual meeting.

Eli Lilly's oral JAK inhibitor Olumiant effectively improves pain / body function / morning stiffness of joints

Eli Lilly's oral JAK inhibitor Olumiant effectively improves pain / body function / morning stiffness of joints

Eli Lilly and its partner Incyte recently announced the oral JAK inhibitor Olumiant (ailemin®, generic name: baricitinib) at the 2021 European Academy of Rheumatology Annual Meeting for the treatment of moderate to severe rheumatoid arthritis (RA).

Novartis iptacopan reaches the primary end point in phase 2 clinical treatment of IgA nephropathy

Novartis iptacopan reaches the primary end point in phase 2 clinical treatment of IgA nephropathy

On the 6th, Novartis announced the primary endpoint data of a phase 2 study of iptacopan, the most advanced asset in its nephrology pipeline

Samsung Pharmaceuticals and GemVax submit new drug Phase III trial results

Samsung Pharmaceuticals and GemVax submit new drug Phase III trial results

Samsung Pharmaceutical Co.

Preliminary clinical results of HER3-targeted ADC for non-small cell lung cancer are positive

Preliminary clinical results of HER3-targeted ADC for non-small cell lung cancer are positive

Daiichi Sankyo recently announced that its investigational antibody conjugate (ADC) patritumab deruxtecan, which targets HER3, has been shown to be effective in a phase 1 clinical trial for the treatment of non-small cell lung cancer (NSCLC) patients with drug-resistant EGFR mutations.

Study announces preliminary results of taletrectinib treatment of ROS1 fusion-positive NSCLC trial

Study announces preliminary results of taletrectinib treatment of ROS1 fusion-positive NSCLC trial

Baoyuan Bio and Xinda Bio jointly announced on the 5th that they will report the preliminary results of the ongoing phase 2 clinical trial of taletrectinib during the ASCO annual meeting in the form of a poster

Specific pancreatic cancer remission rate is 42%.

Specific pancreatic cancer remission rate is 42%.

Amgen announces latest results of KRAS inhibitors, specific lung cancer patients benefit more

Amgen announces latest results of KRAS inhibitors, specific lung cancer patients benefit more

A few days ago, Amgen’s KRAS G12C inhibitor Lumakras was approved by the US FDA for the treatment of treated non-small cell lung cancer patients with KRAS G12C mutations

Corning Jerry Announces Phase II Clinical Data of KN046 Combined with Chemotherapy in the Treatment of Advanced NSCLC

Corning Jerry Announces Phase II Clinical Data of KN046 Combined with Chemotherapy in the Treatment of Advanced NSCLC

On the 7th, Corning Jerry announced that at the 2021 American Society of Clinical Oncology Annual Meeting, the PD-L1/CTLA-4 bispecific antibody KN046 combined with platinum-based chemotherapy for the treatment of advanced non-small cell lung cancer patients will be announced in the form of a poster.

Johnson & Johnson's anti-FcRn antibody filed for clinical application in China

Johnson & Johnson's anti-FcRn antibody filed for clinical application in China

Recently, CDE announced that Johnson & Johnson has submitted a clinical trial application for a class 1 biological new drug nipocalimab injection in China, and it has been accepted by the CDE
.
Public information shows that nipocalimab (M281) is a clinically proven potential "best-in-class" anti-FcRn antibody, which has the potential to treat a variety of autoimmune diseases
.
(CDE)

US FDA approves Tembexa: the first smallpox antiviral drug for all ages

US FDA approves Tembexa: the first smallpox antiviral drug for all ages

Chimerix recently announced that the US FDA has approved Tembexa (brincidofovir) tablets and oral suspensions for the treatment of smallpox
.
Tembexa is suitable for adult and pediatric patients, including newborns
.
It is worth mentioning that Tembexa is the first smallpox antiviral drug approved for use in all age groups, including infants and patients with dysphagia
.
Tembexa is an oral antiviral drug, including 100mg tablets and 10mg/ml oral suspension, taken once a week for 2 weeks of treatment
.
(Bio Valley)

Xinlitai hypertension drug allisartan medoxomil and indapamide sustained-release tablets received clinical approval

Xinlitai hypertension drug allisartan medoxomil and indapamide sustained-release tablets received clinical approval

Xinlitai issued an announcement stating that the company had received the "Clinical Trial Approval Notice" approved and issued by the State Food and Drug Administration, and agreed to carry out clinical trials for allisartan medoxomil and indapamide sustained-release tablets
.
The drug is an ARB/diuretic compound preparation, and its intended development indication is antihypertensive
.
(Sina Pharmaceutical News)

Kangtai Bio freeze-dried Haemophilus influenzae type b conjugate vaccine obtained drug registration certificate

Kangtai Bio freeze-dried Haemophilus influenzae type b conjugate vaccine obtained drug registration certificate

Kangtai Biological issued an announcement stating that its wholly-owned subsidiary Minhai Biological recently received the "Drug Registration Certificate" issued by the State Drug Administration
.
In accordance with the "Drug Administration Law of the People's Republic of China", "The People's Republic of China Vaccine Administration Law" and related regulations, after review, the freeze-dried Haemophilus influenzae type b conjugate vaccine declared by Minhai Biotech meets the relevant requirements for drug registration, and the registration is approved and issued.
Give the drug registration certificate
.
(a)

Shanghai Pharmaceuticals duloxetine hydrochloride enteric-coated tablets passed the consistency evaluation of generic drugs

Shanghai Pharmaceuticals duloxetine hydrochloride enteric-coated tablets passed the consistency evaluation of generic drugs

On the 7th, Shanghai Pharmaceuticals issued an announcement stating that recently, its holding subsidiary, Shanghai Pharmaceuticals Zhongxi, received the "Drug Supplementary Application Approval Notice" (notice number: 2021B01547) on duloxetine hydrochloride enteric-coated tablets issued by the State Food and Drug Administration.
), the drug passed the quality and efficacy consistency evaluation of generic drugs
.
The drug is mainly used to treat depression
.
(a)

Harbin Pharmaceutical Group: Simvastatin tablets passed the consistency evaluation of generic drugs

Harbin Pharmaceutical Group: Simvastatin tablets passed the consistency evaluation of generic drugs

On the 7th, Harbin Pharmaceutical Group stated that its subsidiary Harbin Pharmaceutical Group Sanjingmingshui Pharmaceutical Co.
, Ltd.
received the "Approval for Supplementary Drug Application" for simvastatin tablets issued by the State Food and Drug Administration.
The drug passed the quality and efficacy of generic drugs.
Consistency evaluation
.
The drug is mainly suitable for hyperlipidemia and coronary heart disease
.
(a)

Tianyao Pharmaceutical's adrenaline hydrochloride injection passed the consistency evaluation of generic drugs

Tianyao Pharmaceutical's adrenaline hydrochloride injection passed the consistency evaluation of generic drugs

Tianyao Pharmaceutical issued an announcement stating that its subsidiary Tianjin Jinyao Pharmaceutical Co.
, Ltd.
received the "Drug Supplement Application Approval Notice" for epinephrine hydrochloride injection approved and issued by the State Food and Drug Administration, and approved the drug to pass the quality and quality of generic drugs.
Consistency evaluation of efficacy
.
The drug is mainly suitable for severe breathing difficulties caused by bronchospasm, can quickly relieve anaphylactic shock caused by drugs, etc.
, can also be used to prolong the action time of infiltrating anesthetics, and the main reason for cardiopulmonary resuscitation caused by cardiac arrest caused by various reasons Rescue medication
.
(a)

Qilu enters the market with annual sales of $1.
9 billion blockbuster drug and Chengdu Beite competes for the first imitation

Qilu enters the market with annual sales of $1.
9 billion blockbuster drug and Chengdu Beite competes for the first imitation

On the 7th, Qilu Pharmaceuticals applied for the 4 types of generic listing applications for emtricitabine propofol tenofovir tablets (I) and emtricitabine propofol tenofovir tablets (II).
At present, only the original research drug is available in China.
Imports were approved in 2018, and no domestic generic drugs have been approved yet
.
(Minenet)

JEM: Demystifying the molecular mechanism by which platelets help cope with lung inflammation in the body

JEM: Demystifying the molecular mechanism by which platelets help cope with lung inflammation in the body

Recently, scientists from the Faculty of Medicine of the University of Münster, Germany, have deeply revealed the cellular processes involved in bacterial lung inflammation through research; in the process of studying mice, the researchers found that platelets and specific white blood cells (regulators) The interaction between sex T cells may play a very critical role in resolving inflammation in the body
.
(Bio Valley)