"Pharmaceutical Speed ​​Reading Society" Keytruda's 7th indication was approved in China for the grassroots...

[June 15, 2021/Medical Information List] GSK/iTeos jointly developed anti-TIGIT antibodies; Roche's ophthalmic bispecific antibody Faricimab submitted a new drug application in Japan; Cinda Bio's bispecific fusion protein was approved for clinical use; Ruiming's new drug was completed Nearly 100 million yuan in A+ round of financing.

[June 15, 2021/Medical Information List] Daily news of fresh medicines and medical news, speed reading and follow you together!

Part1 Policy Brief

Part1 policy briefing Part1 policy briefing

Primary physicians can be transferred

Primary physicians can be transferred

According to the Anhui Provincial Health and Health Commission, in recent years, Xiaoxian has put forward new measures in the training of general practitioners in order to improve the "primary-level first consultation" medical service capabilities, and strive to build a high-level medical and health personnel team

The Medical Insurance Bureau issued the "Medical Security Law (Draft for Solicitation of Comments)" to strengthen price monopoly supervision

The Medical Insurance Bureau issued the "Medical Security Law (Draft for Solicitation of Comments)" to strengthen price monopoly supervision

On the 15th, the National Medical Insurance Administration issued the "Medical Insurance Law (Draft for Solicitation of Comments)", and the long-awaited medical insurance law finally unveiled

Part2 Observation

Part2 Sankei Observation Part2 Sankei Observation

GSK/iTeos reached US$2 billion to jointly develop anti-TIGIT antibodies

GSK/iTeos reached US$2 billion to jointly develop anti-TIGIT antibodies

Recently, GlaxoSmithKline and iTeos Therapeutics jointly announced that they will jointly develop and promote the anti-TIGIT antibody EOS-448 in phase 1 clinical development

Ruiming New Drug completed nearly 100 million yuan in A+ round of financing

Ruiming New Drug completed nearly 100 million yuan in A+ round of financing

Recently, Ruiming New Drug announced the completion of nearly 100 million yuan in A+ round of financing

Yudao Biotech officially announced the completion of a US$20 million Series A financing

Yudao Biotech officially announced the completion of a US$20 million Series A financing

Recently, Yudao Biotech officially announced the completion of a US$20 million Series A financing to promote the construction of its computing-driven allosteric drug research and development platform and the clinical research and development of allosteric drug candidates

Boji Pharmaceuticals: The company has carried out research on drugs related to Alzheimer's disease

Boji Pharmaceuticals: The company has carried out research on drugs related to Alzheimer's disease

On the 15th, Boji Pharmaceuticals disclosed on related platforms that the company has carried out preclinical research, clinical research, and IND application for drugs related to Alzheimer's disease

Part3 Medicine News

Part3 Medicine News Part3 Medicine News

Johnson & Johnson Imbruvica combined with Roche Venclexta successfully treats CLL/SLL Phase III clinical trial

Johnson & Johnson Imbruvica combined with Roche Venclexta successfully treats CLL/SLL Phase III clinical trial

On the 14th, according to foreign media reports, Johnson & Johnson’s Imbruvica and Roche’s Genentech’s Venclexta were successful in a phase III GLOW study.

90.

90.

The complete remission rate of refractory patients exceeds 30%, and the phase 2 clinical results of CD37-targeted ADC combination are positive

The complete remission rate of refractory patients exceeds 30%, and the phase 2 clinical results of CD37-targeted ADC combination are positive

On the 14th, Debiopharm announced that its CD37 targeting antibody conjugated drug naratuximab emtansine, combined with rituximab, has achieved positive results in a phase 2 clinical trial for the treatment of relapsed/refractory diffuse large B-cell lymphoma

Avenue's new drug application for non-opioid painkiller tramadol again rejected by the FDA

Avenue's new drug application for non-opioid painkiller tramadol again rejected by the FDA

A few days ago, the US FDA issued a complete response letter with detailed information showing that the FDA once again refused to approve Avenue Therapeutics intravenous injection, non-opioid painkiller tramadol

BMS immunocombination therapy Opdivo+Yervoy is approved by NICE in the UK for the treatment of patients with advanced bowel cancer

BMS immunocombination therapy Opdivo+Yervoy is approved by NICE in the UK for the treatment of patients with advanced bowel cancer

UK NICE recently released a final evaluation document recommending the use of Bristol-Myers Squibb's immunocombination therapy Opdivo+Yervoy for the treatment of certain patients with advanced bowel cancer, specifically: failure to receive fluoropyrimidine chemotherapy and rare high instability of microsatellites Or patients with advanced bowel cancer with mismatch repair defect mutations

Merck's Keytruda 7th indication is approved in China for the first-line treatment of colorectal cancer

Merck's Keytruda 7th indication is approved in China for the first-line treatment of colorectal cancer

On the 15th, Merck announced that its blockbuster PD-1 inhibitor pembrolizumab has been approved by the NMPA.

APL-1202 and tislelizumab combined with neoadjuvant treatment of MIBC new drug clinical research application approved by FDA

APL-1202 and tislelizumab combined with neoadjuvant treatment of MIBC new drug clinical research application approved by FDA

On the 15th, Yahong Pharmaceutical announced that APL-1202 and tislelizumab combined with neoadjuvant treatment of myometrial invasive bladder cancer had been approved by the FDA for clinical research

Roche's ophthalmic bispecific antibody Faricimab submits a new drug application in Japan

Roche's ophthalmic bispecific antibody Faricimab submits a new drug application in Japan

Recently, Roche’s Chugai Pharmaceutical Co.

Aripiprazole oral solution is planned to be included in the priority review

Aripiprazole oral solution is planned to be included in the priority review

On the 15th, CDE announced the latest announcement that the aripiprazole oral solution of Sichuan Otsuka Pharmaceutical Co.
, Ltd.
, a subsidiary of Otsuka Pharmaceuticals, was included in the priority review by CDE for new varieties, dosage forms and specifications of children’s drugs that meet the physiological characteristics of children.
Symptoms are: irritable symptoms of autism in children and adolescents aged 6-17 years; Tourette's syndrome in children and adolescents aged 6-17 years
.
(CDE)

Oakrum/Oakrum announces the launch of JADENU(R) Sprinkle generic drug

Oakrum/Oakrum announces the launch of JADENU(R) Sprinkle generic drug

On the 14th, Okoda Pharmaceuticals and Oakrum Pharmaceuticals formally announced the successful launch of JADENU(R) Sprinkle's generic drugs, including three specifications of 90mg, 180mg, and 360mg
.
(PR Newswire)

Jingfeng Pharmaceutical's gemcitabine hydrochloride for injection passed the consistency evaluation of generic drugs

Jingfeng Pharmaceutical's gemcitabine hydrochloride for injection passed the consistency evaluation of generic drugs

On the 15th, Jingfeng Pharmaceutical announced that its subsidiary Hainan Jinrui Pharmaceutical received the "Drug Supplementary Application Approval Notice" for gemcitabine hydrochloride for injection approved and issued by the State Food and Drug Administration.
The quality and efficacy of the subsidiary gemcitabine hydrochloride for injection passed the generic drug.
Sexual evaluation
.
Gemcitabine hydrochloride for injection is mainly suitable for the treatment of locally advanced or metastatic non-small cell lung cancer or pancreatic cancer.
It can also be combined with paclitaxel for the treatment of relapsed, unresectable, locally recurring or metastatic breast after adjuvant/neoadjuvant chemotherapy Cancer
.
(a)

Healthyuan Omeprazole Sodium for Injection Passed the Consistency Evaluation of Generic Drugs

Healthyuan Omeprazole Sodium for Injection Passed the Consistency Evaluation of Generic Drugs

On the 15th, Joincare announced that Livzon Pharmaceutical Factory, a wholly-owned subsidiary, received the "Drug Supplementary Application Approval Notice" approved and issued by the National Medical Products Administration.
The omeprazole sodium for injection produced by Livzon Pharmaceutical Factory passed generic drugs.
Consistency evaluation of quality and efficacy
.
Omeprazole sodium for injection is a category B product in the "National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drug Catalog" (Yibaofa [2020] No.
53), and its indications are: ① bleeding from peptic ulcer, bleeding from anastomotic ulcer; ② Acute gastric mucosal damage complicated by stress and acute gastric mucosal damage caused by non-steroidal anti-inflammatory drugs; ③ Prevention of severe diseases (such as cerebral hemorrhage, severe trauma, etc.
) stress state and upper digestion after gastric surgery Tract bleeding, etc.
; ④ as an alternative therapy for the following conditions when oral therapy is not applicable: duodenal ulcer, gastric ulcer, reflux esophagitis and Zollinger-Ellison syndrome
.
(a)

Zhejiang Pharmaceutical Vancomycin Hydrochloride for Injection Passed the Consistency Evaluation of Generic Drugs

Zhejiang Pharmaceutical Vancomycin Hydrochloride for Injection Passed the Consistency Evaluation of Generic Drugs

On the 15th, Zhejiang Medicine announced that it has recently received a "Drug Supplementary Application Approval Notice" of 0.
5g (500,000 units) of vancomycin hydrochloride for injection approved and issued by the State Drug Administration, which approved the drug to pass the quality and efficacy of generic drugs Consistency evaluation
.
Vancomycin is a narrow-spectrum glycopeptide antibiotic produced by a strain of Streptomyces orientalis
.
Mainly effective against gram-positive bacteria, suitable for infections caused by methicillin-resistant Staphylococcus aureus and other bacteria: sepsis, infective endocarditis, osteomyelitis, arthritis, burns, surgical trauma, etc.
Secondary infection, pneumonia, lung abscess, empyema, peritonitis, meningitis
.
(a)

Shouxiangu: Gynecological Shiwei Tablets Received Drug Re-registration Approval Notice

Shouxiangu: Gynecological Shiwei Tablets Received Drug Re-registration Approval Notice

On the 15th, Shouxiangu stated that its wholly-owned subsidiary Jinhua Kangshou Pharmaceutical Co.
, Ltd.
received the "Drug Re-registration Approval Notice" approved and issued by the Zhejiang Provincial Drug Administration
.
After review, it was agreed to re-register this product
.
Since this product has not been produced for a long time, when production is resumed, an application for on-site inspection must be submitted to the Zhejiang Food and Drug Administration.
After on-site inspection and random inspection of a batch of products, it can be marketed
.
(a)

Jingxin Pharmaceutical Memantine Hydrochloride Sustained Release Capsules Obtained Drug Registration Approval

Jingxin Pharmaceutical Memantine Hydrochloride Sustained Release Capsules Obtained Drug Registration Approval

On the 15th, Jingxin Pharmaceutical announced that it had recently received the "Drug Registration Certificate" for the chemical drug "Memantine Hydrochloride Sustained Release Capsules" [Specification 28mg] approved and issued by the State Food and Drug Administration
.
Memantine hydrochloride is a low to moderate affinity non-competitive N-formyl-D-aspartate receptor antagonist, suitable for moderate to severe Alzheimer's dementia
.
(a)

Cinda Bio's dual-specific fusion protein was approved for clinical use

Cinda Bio's dual-specific fusion protein was approved for clinical use

The latest announcement by CDE shows that Cinda Biologics Class 1 new drug IBI302 has obtained the implied approval of a clinical trial to develop the treatment of diabetic macular edema
.
(CDE)

Sansheng Guojian HER2/PD-1 bispecific antibody was approved by the U.
S.
FDA to enter the clinic

Sansheng Guojian HER2/PD-1 bispecific antibody was approved by the U.
S.
FDA to enter the clinic

On the 14th, Sansheng Guojian announced that a clinical trial evaluating the bispecific antibody SSGJ-705 has recently been approved by the US FDA to enter a phase I clinical trial
.
SSGJ-705 related preclinical research results have been published in the core journal Acta Pharmacologica Sinica recently
.
Studies have shown that SSGJ-705 has a high affinity with human HER2 protein and PD-1 protein, has HER2 inhibitory and PD-1 blocking activities, and exhibits strong anti-tumor activity in vitro and in animal models
.
(PR Newswire)

Hans Biotech initiates Phase 2 clinical trial of CD47/PD-1 bispecific antibody

Hans Biotech initiates Phase 2 clinical trial of CD47/PD-1 bispecific antibody

Recently, Hansi Biotechnology announced that it has initiated a phase 2 clinical study of the anti-CD47/PD-1 bispecific antibody HX009 injection, and plans to develop the treatment of advanced solid tumors
.
As of April 2021, the 7 dose groups in Australia have completed the dose escalation enrollment, and a total of 21 patients have been enrolled in the group.
No dose-limiting toxicity and maximum tolerated dose have been observed, and the safety and tolerability are good
.
(WuXi AppTec)

Millions of doses of Johnson & Johnson's new crown vaccine are scrapped in South Africa, requiring replacement

Millions of doses of Johnson & Johnson's new crown vaccine are scrapped in South Africa, requiring replacement

South African regulators announced on the 13th that South Africa will not distribute millions of doses of "problem vaccines" produced in a US factory and is discussing exchanges with vaccine supplier Johnson & Johnson
.
The South African Health Products Regulatory Authority issued a statement saying that after evaluating the data provided by the US FDA, the agency decided not to distribute the new crown vaccine delivered by Johnson & Johnson that may have raw material contamination problems
.
Officials from the South African Ministry of Health said the decision involved 2 million doses of Johnson & Johnson vaccines, which are currently stored in a laboratory of South Africa’s largest pharmaceutical company, Ai Shijian
.
The official said that the South African government is negotiating with Johnson & Johnson to return the vaccine
.
(Sina Pharmaceutical News)

Phase 2 clinical results of innovative tau protein vaccine for the treatment of Alzheimer's disease published

Phase 2 clinical results of innovative tau protein vaccine for the treatment of Alzheimer's disease published

Today, Axon Neuroscience announced that the complete results of the Phase 2 clinical trial of its tau protein vaccine AADvac1 for the treatment of Alzheimer's disease were published in the sub-published Nature Aging
.
The test results show that AADvac1 has excellent safety and stimulates a strong antibody response, which has a significant impact on neurodegeneration
.
(WuXi AppTec)