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China's first new class 1 drug for Ebomycin breast cancer has been approved for sale

 Last Update: 2021-03-25
 Source: Internet
 Author: User

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【2021312 / 】1；；……，！

Part1

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On March 12, the State Food and Drug Administration issued a notice on the official website of the "Announcement on the Registration of Medical Device Master Files".

Chengdu Health Commission launched a special rectification action for "illegal medical beauty"

On March 12, the Chengdu Municipal Health Commission organized the city to launch a special rectification action focusing on combating "illegal medical beauty".

A pharmacy worker was sentenced to four years in prison for prescribing the wrong medicine and causing death

On March 11, according to Xijiang Metropolis Daily, the People’s Court of Changzhou District, Wuzhou City recently issued a first-instance verdict on a case of death caused by negligence by a drugstore owner.

Part2 Observation

Part2 Sankei Observation Part2 Sankei Observation

China Resources Sanjiu Director Liu Wentao resigns

On March 12, China Resources Sanjiu issued an announcement stating that it received a resignation report from director Liu Wentao.

Liang Xu served as Vice President of Tengshengbo Pharmaceutical Science and Medical Affairs

On March 12, Tengshengbo Pharmaceutical announced the appointment of Mr.

Cao Shaohua appointed as the new head of Ogalon's Women's Health Division in China

Today, Shi Wang, head of Organon China, announced an appointment to employees.

Nuocheng Jianhua intends to be listed on the Science and Technology Innovation Board

On March 11, Nuocheng Jianhua issued an announcement that the company’s board of directors decided to issue RMB shares and list them on the Science and Technology Innovation Board of the Shanghai Stock Exchange.

Chuangxin International completed nearly 100 million yuan of A round of financing

Recently, Chuangxin International announced that it has completed a round of financing of nearly 100 million yuan, led by Qudao Assets.

Luoqi Biotechnology completes 100 million yuan RMB A round of financing

Artery Network was informed for the first time that, recently, Luo Qi Biotechnology announced the completion of a 100 million yuan A round of financing.

Part3 Medicine News

Part3 Medicine News Part3 Medicine News

BNT162b2 prevents asymptomatic infections up to 94%

Today, Pfizer, BioNTech and the Israeli Ministry of Health jointly announced that real-world data show that the new crown vaccine BNT162b2 jointly developed by Pfizer and BioNTech is 97% effective in preventing symptomatic COVID-19 and preventing asymptomatic infections.

Li's drug company's anti-PD-L1 monoclonal antibody was approved for Phase 3 clinical trials

Recently, Li’s large pharmaceutical company announced that its subsidiary, China Oncology Medical, has obtained NMPA approval for clinical trial applications to conduct multi-center, randomized, double-blind, and parallel grouping of Socazolimab combined with chemotherapy for the first-line treatment of diffuse small cell lung cancer.

Roche Actemra combined with Redecivir in the treatment of severe COVID-19 patients with phase III clinical failure

On March 10, Roche’s Genentech announced that the Phase III REMDACTA study evaluating the anti-inflammatory drug Actemra combined with Veklury in the treatment of patients with severe COVID-19 pneumonia did not meet the primary and key secondary endpoints.

GlaxoSmithKline/Vir Biotechnology Antibody Therapy Terminates Phase 3 Clinical Trials Early

Today, Vir Biotechnology and GlaxoSmithKline jointly announced that based on the results of a positive interim analysis of their jointly developed neutralizing antibody therapy VIR-7831, the independent data monitoring committee recommended the early termination of VIR-7831 for the treatment of high-risk COVID-19 patients Phase 3 clinical trials.

KRAS inhibitors add new force to Eli Lilly's innovative therapies to start clinical trials

A few days ago, Eli Lilly announced that it will announce the preclinical research results of its next-generation KRAS G12C specific inhibitor LY3537982 at the AACR annual meeting in April this year.

The EU approves the first single-dose COVID-19 vaccine

On March 12, the European Medicines Agency announced on the 11th that it had evaluated the results of a new crown vaccine developed by Johnson & Johnson's Janssen Pharmaceutical Co.

Eli Lilly's RET inhibitor Retsevmo is approved in the UK for the treatment of advanced lung/thyroid cancer

On March 11, according to foreign media reports, the British Medicines and Health Products Administration granted Eli Lilly’s Retsevmo a conditional marketing license for the treatment of RET fusion-positive advanced lung cancer and thyroid cancer.

AstraZeneca's targeted drug Tagrisso approved in India

AstraZeneca India recently announced that the targeted anti-cancer drug Tagrisso has been approved in India for the adjuvant treatment of non-small cell lung cancer patients whose tumors carry epidermal growth factor receptor mutations after complete tumor resection.
(Bio Valley)

Novartis Kymriah Singapore HSA approved

Novartis recently announced that the Singapore Health Sciences Authority has recently approved Kymriah as Singapore’s first commercial chimeric antigen receptor T cell therapy.
Kymriah is a CD19-directed genetically modified autologous T cell immune cell therapy for the treatment of two types of B cell malignancies.
(Bio Valley)

China's first epothilone breast cancer class 1 new drug Utidelone approved for marketing

On March 12, the NMPA website showed that Huahao Zhongtian's Class 1 new drug Utidelone obtained the drug approval number.
In June 2018, the drug's marketing application for the treatment of patients with metastatic or locally advanced breast cancer was included in the priority review by the Drug Evaluation Center.
The acceptance number associated with the approval document number obtained this time is the same as the registration acceptance number, which means that Utidal is officially approved in China for the treatment of breast cancer.
(Immediately smell the medicine)

Xintai Pharmaceutical's Oxiracetam Injection Approved for Listing

On March 11, the official website of NMPA showed that Xintai Pharmaceutical's Oxiracetam injection was approved for marketing.
It is understood that Oxiracetam injection is an analogue of piracetam, which can improve the memory and learning function of patients with Alzheimer's disease and memory disorders, and is suitable for brain damage and the neurological deficit, memory and intellectual impairment caused by it.
Treatment of other diseases.
(Minenet)

Hengrui Medicine: SHR-1707 injection was approved for clinical trials

On March 12, Hengrui Pharmaceuticals announced that its subsidiary has recently received the approval and issuance of the "Drug Clinical Trial Approval Notice" for SHR-1707 injection from the National Medical Products Administration, and clinical trials will be launched in the near future.
SHR-1707 injection can prevent the assembly of β-amyloid plaques or activate microglia to engulf various forms of Aβ, thereby reducing the Aβ level in the brain of AD patients, and ultimately delaying the patient’s cognitive function degradation and controlling disease progression .
(Announcement of Hengrui Medicine)

Fuan Pharmaceutical Escitalopram Oxalate Tablets Entered the Administrative Approval Stage

Recently, Fu'an Pharmaceutical entered the administrative examination and approval stage with the imitation of escitalopram oxalate tablets reported for production in Category 4, and it is expected to be approved for production in the near future.
Escitalopram oxalate tablets are the single dextrorotatory optical isomer of the dicyclic hydrogen phthalate derivative racemic citalopram, which is used to treat depression and panic disorder.
Compared with similar antidepressants, escitalopram oxalate tablets have better efficacy and acceptability, and are the first-line drugs for the treatment of depression.
(Minenet)

Osaikon's "Eltrombopag ethanolamine tablets" will be approved soon

Recently, the listing application of Jiangsu Osaikang's 4-category generic drug Eltrombopag ethanolamine tablets has been changed to "under approval" status, and it is expected to be approved for listing this month.
Previously, Eltroipopag ethanolamine tablets were used to treat thrombocytopenia in patients with chronic primary immune thrombocytopenia after splenectomy or after glucocorticoid drugs, immunoglobulin therapy failed.
(CPhl Pharmaceutical Online)

Pemetrexed disodium for injection passed the consistency evaluation of generic drugs

On March 12, Osaikang issued an announcement stating that Jiangsu Osaikang Pharmaceutical, a wholly-owned subsidiary, has recently received the "Notice of Approval of Drug Supplement Application" approved by the State Food and Drug Administration for injection.
The drug passed the consistency evaluation.
It is understood that the pemetrexed disodium for injection developed by our company is used for the treatment of locally advanced or metastatic non-squamous cell non-small cell lung cancer or inoperable malignant pleural mesothelioma; or a single drug used in the first line of previous acceptance Treatment of locally advanced or metastatic non-squamous cell non-small cell lung cancer patients who have progressed after chemotherapy.
(Osaikon Announcement)

CSPC Entecavir Tablets and Ceftriaxone Sodium for Injection have successively reviewed

According to the latest news from the NMPA official website, CSPC’s entecavir tablets have been approved for production and deemed to have been reviewed.
At the same time, ceftriaxone sodium for injection has also passed the consistency evaluation.
Entecavir is a guanine nucleoside analog, which has an inhibitory effect on hepatitis B virus reverse transcriptase.
It has been recommended as a first-line antiviral drug by multiple hepatitis B diagnosis and treatment guidelines.
Ceftriaxone sodium has high antibacterial activity against most gram-negative and positive bacteria.
(Minenet)

7567 people in South Korea have suspected adverse reactions after vaccinating AstraZeneca

On March 12, according to Yonhap News Agency, the South Korean New Crown Vaccination Promotion Group reported that since South Korea started the new crown vaccination, a total of 7,648 suspected adverse reactions after vaccination have been reported.
Among them, 7567 cases were related to AstraZeneca vaccine, accounting for 98.
9% of the total, and the remaining 81 cases were related to Pfizer vaccine.
(Associated Finance Press)

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