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Recent popular reports from Yimaike Reindeer Medical and Cinda Bio will verbally report the research results of the all-human BCMA CAR-T therapy (CT103A) at the 2021 EHA conference.
Yimai Meng broke the news.
★Sibman dual-target CAR-T data stunning ASCO , The total remission rate reached 92.
6%Yimai Meng broke the news, click on the picture, and register now June 9, 2021 / Yimaike News eMedClub News/-June 9th, China National Medical Products Administration (NMPA) announced that Rongchang Biological application Vidicitor for injection (trade name: Aidixi) has passed the priority review and approval procedure with conditional approval for listing
.
Vidicuzumab is a conjugate drug (ADC), suitable for the treatment of patients with locally advanced or metastatic gastric cancer (including gastroesophageal junction adenocarcinoma) who have received at least 2 types of systemic chemotherapy
.
▲ Picture source: NMPA official website is in China.
In August 2020, the new drug listing application of vedicitumumab was accepted by CDE, and was included in the priority review because of "medicine eligible for approval"
.
This approval of the drug means that the country has ushered in the first self-developed ADC drug
.
Positive effects of drugs targeting ADC in indications Vidicutumab is an antibody-conjugated drug (ADC) targeting HER2 developed by Rongchang Biological
.
It is mainly used to treat common HER2 expression indications that currently lack treatment methods, including: HER2 expression (IHC 1+ or above) cancer indications other than breast cancer, such as gastric cancer and urothelial cancer; and cancers with low HER2 expression ( IHC 2+/FISH- or IHC 1+) indications, such as breast cancer with low HER2 expression
.
According to the press release, the antibody component of vedicitumumab is a brand-new drug with differentiated biological properties
.
Its molecular structure includes a new type of humanized HER2 antibody, which is lysable when attached to tumor cells, and its small molecule cytotoxic drugs have high toxicity and side-killing effects
.
The candidate drug can target the HER2 protein on the tumor surface, accurately identify cancer cells, penetrate cell membranes, and then use small-molecule cytotoxic drugs to kill them
.
It is reported that the gastric cancer marketing application submitted by the drug in China is based on data from a phase 2 registered clinical trial
.
In this study, vedicitumumab showed excellent anti-tumor activity and good tolerability
.
According to research data: as of June 22, 2020, for 127 patients with HER2 overexpression (IHC 2+ or IHC 3+) gastric cancer or gastroesophageal junction adenocarcinoma who had received second-line chemotherapy treatment, vedicitadan The objective response rate (ORR) of anti-antibiotics was 24.
4% (as assessed and confirmed by the independent review committee), the median progression-free survival (PFS) was 4.
1 months, and the median overall survival (OS) was 7.
6 months
.
Not only that, in addition to gastric cancer, vedicitumumab is currently conducting clinical studies on urothelial cancer, HER2 low-expressing breast cancer, lung cancer and cholangiocarcinoma, etc.
, among them, for the detection of HER2 overexpression locally advanced or metastatic urothelial cancer The application of skin cancer patients has been included in the breakthrough treatment category by CDE in December 2020
.
In addition, at the ASCO conference in 2021, Rongchang Biological announced a number of clinical research data of vedicitumumab
.
Preliminary results of one of the phase 1b/2 studies showed that: vedicitumumab combined with anti-PD-1 monoclonal antibody teriprizumab in the first-line treatment of metastatic urothelial carcinoma, in 16 patients with different levels of HER2 expression Among them, the objective response rate (ORR) reached 100%
.
Another study on breast cancer patients also showed that vedicitumumab has also achieved a good effect on breast cancer patients with low HER2 expression
.
At present, Rongchang Biological is exploring the curative effect of Vidicuzumab on a global scale
.
In the United States, the FDA granted fast-track drug designation for the treatment of advanced or metastatic gastric cancer and gastroesophageal junction adenocarcinoma, and granted breakthrough therapy designation and fast-track designation for the treatment of urothelial cancer.
.
Competition in the ADC market is fierce In recent years, the wave of ADC drug research and development has continued to be hot, and a large number of developers have poured in.
Among them, ADC has a very promising development prospect and firmly attracts a large number of companies
.
So far, 11 ADC drugs have been approved for marketing worldwide
.
In this field, 2019 ushered in an unprecedented major breakthrough.
Within a year, three drugs were approved by the US FDA for marketing, and two ADC drugs were approved for marketing in 2020
.
Recently, Rongchang Biotech's Vidicuzumab was listed as the first domestically developed ADC
.
In addition, ADC drugs introduced from abroad have seized the opportunity in the Chinese market.
At present, Roche’s Kadcyla is the main product.
The drug will land in China in January 2020 and become the first ADC drug approved for marketing in China
.
Takeda's Adcetris was also approved for listing in China in May 2020
.
Overland Pharmaceuticals, launched by Hillhouse Capital in 2020, also won the exclusive rights of ADC Therapeutics’ CD19 ADC drug loncastuximab tesirine (Lonca), as well as three other ADC candidate products in Greater China and Singapore.
A heavy player of domestic ADC players
.
Recommended reading: Another heavyweight player has been added to the domestic ADC track, and the start-up company holds a potential commercial CD19 ADC drug Yimai Meng broke the news that the FDA has approved the first CD19 targeted ADC drug, and Linglu Pharmaceutical owns Chinese rights Medicine Mai Meng broke the news that in May this year, Genting Xinyao's domestic listing application for the TROP-2 ADC imported from Immunomedics has also been accepted by the CDE
.
Recommended reading: The TROP-2 ADC introduced by Genting Xinyao applies for listing in China and plans to be granted priority review.
Yimai Meng broke the news that Cornerstone Pharmaceuticals also ended the ADC field and bought it from LegoChem Biosciences with a down payment of 10 million US dollars Exclusive development and commercialization authorization of ROR1 ADC (LCB71) in global regions outside Korea
.
Reference: WuXi AppTec "Just now! Rongchang Bio's ADC "Vedicituzumab" was approved to treat gastric cancer" Yimaike has always been committed to the cutting-edge technology, industry trends, industry insights and other original news reports of bio-innovative drugs.
The high-end matrix users of all media reached 160,000+, of which Industrial users accounted for more than 50%, scientific research and clinical users accounted for about 30%, and investment institutions accounted for more than 5%
.
In order to promote interactive exchanges in industry segments, we have established a number of professional WeChat groups, welcome to scan the QR code to add groups
.
Yimai Meng broke the news.
★Sibman dual-target CAR-T data stunning ASCO , The total remission rate reached 92.
6%Yimai Meng broke the news, click on the picture, and register now June 9, 2021 / Yimaike News eMedClub News/-June 9th, China National Medical Products Administration (NMPA) announced that Rongchang Biological application Vidicitor for injection (trade name: Aidixi) has passed the priority review and approval procedure with conditional approval for listing
.
Vidicuzumab is a conjugate drug (ADC), suitable for the treatment of patients with locally advanced or metastatic gastric cancer (including gastroesophageal junction adenocarcinoma) who have received at least 2 types of systemic chemotherapy
.
▲ Picture source: NMPA official website is in China.
In August 2020, the new drug listing application of vedicitumumab was accepted by CDE, and was included in the priority review because of "medicine eligible for approval"
.
This approval of the drug means that the country has ushered in the first self-developed ADC drug
.
Positive effects of drugs targeting ADC in indications Vidicutumab is an antibody-conjugated drug (ADC) targeting HER2 developed by Rongchang Biological
.
It is mainly used to treat common HER2 expression indications that currently lack treatment methods, including: HER2 expression (IHC 1+ or above) cancer indications other than breast cancer, such as gastric cancer and urothelial cancer; and cancers with low HER2 expression ( IHC 2+/FISH- or IHC 1+) indications, such as breast cancer with low HER2 expression
.
According to the press release, the antibody component of vedicitumumab is a brand-new drug with differentiated biological properties
.
Its molecular structure includes a new type of humanized HER2 antibody, which is lysable when attached to tumor cells, and its small molecule cytotoxic drugs have high toxicity and side-killing effects
.
The candidate drug can target the HER2 protein on the tumor surface, accurately identify cancer cells, penetrate cell membranes, and then use small-molecule cytotoxic drugs to kill them
.
It is reported that the gastric cancer marketing application submitted by the drug in China is based on data from a phase 2 registered clinical trial
.
In this study, vedicitumumab showed excellent anti-tumor activity and good tolerability
.
According to research data: as of June 22, 2020, for 127 patients with HER2 overexpression (IHC 2+ or IHC 3+) gastric cancer or gastroesophageal junction adenocarcinoma who had received second-line chemotherapy treatment, vedicitadan The objective response rate (ORR) of anti-antibiotics was 24.
4% (as assessed and confirmed by the independent review committee), the median progression-free survival (PFS) was 4.
1 months, and the median overall survival (OS) was 7.
6 months
.
Not only that, in addition to gastric cancer, vedicitumumab is currently conducting clinical studies on urothelial cancer, HER2 low-expressing breast cancer, lung cancer and cholangiocarcinoma, etc.
, among them, for the detection of HER2 overexpression locally advanced or metastatic urothelial cancer The application of skin cancer patients has been included in the breakthrough treatment category by CDE in December 2020
.
In addition, at the ASCO conference in 2021, Rongchang Biological announced a number of clinical research data of vedicitumumab
.
Preliminary results of one of the phase 1b/2 studies showed that: vedicitumumab combined with anti-PD-1 monoclonal antibody teriprizumab in the first-line treatment of metastatic urothelial carcinoma, in 16 patients with different levels of HER2 expression Among them, the objective response rate (ORR) reached 100%
.
Another study on breast cancer patients also showed that vedicitumumab has also achieved a good effect on breast cancer patients with low HER2 expression
.
At present, Rongchang Biological is exploring the curative effect of Vidicuzumab on a global scale
.
In the United States, the FDA granted fast-track drug designation for the treatment of advanced or metastatic gastric cancer and gastroesophageal junction adenocarcinoma, and granted breakthrough therapy designation and fast-track designation for the treatment of urothelial cancer.
.
Competition in the ADC market is fierce In recent years, the wave of ADC drug research and development has continued to be hot, and a large number of developers have poured in.
Among them, ADC has a very promising development prospect and firmly attracts a large number of companies
.
So far, 11 ADC drugs have been approved for marketing worldwide
.
In this field, 2019 ushered in an unprecedented major breakthrough.
Within a year, three drugs were approved by the US FDA for marketing, and two ADC drugs were approved for marketing in 2020
.
Recently, Rongchang Biotech's Vidicuzumab was listed as the first domestically developed ADC
.
In addition, ADC drugs introduced from abroad have seized the opportunity in the Chinese market.
At present, Roche’s Kadcyla is the main product.
The drug will land in China in January 2020 and become the first ADC drug approved for marketing in China
.
Takeda's Adcetris was also approved for listing in China in May 2020
.
Overland Pharmaceuticals, launched by Hillhouse Capital in 2020, also won the exclusive rights of ADC Therapeutics’ CD19 ADC drug loncastuximab tesirine (Lonca), as well as three other ADC candidate products in Greater China and Singapore.
A heavy player of domestic ADC players
.
Recommended reading: Another heavyweight player has been added to the domestic ADC track, and the start-up company holds a potential commercial CD19 ADC drug Yimai Meng broke the news that the FDA has approved the first CD19 targeted ADC drug, and Linglu Pharmaceutical owns Chinese rights Medicine Mai Meng broke the news that in May this year, Genting Xinyao's domestic listing application for the TROP-2 ADC imported from Immunomedics has also been accepted by the CDE
.
Recommended reading: The TROP-2 ADC introduced by Genting Xinyao applies for listing in China and plans to be granted priority review.
Yimai Meng broke the news that Cornerstone Pharmaceuticals also ended the ADC field and bought it from LegoChem Biosciences with a down payment of 10 million US dollars Exclusive development and commercialization authorization of ROR1 ADC (LCB71) in global regions outside Korea
.
Reference: WuXi AppTec "Just now! Rongchang Bio's ADC "Vedicituzumab" was approved to treat gastric cancer" Yimaike has always been committed to the cutting-edge technology, industry trends, industry insights and other original news reports of bio-innovative drugs.
The high-end matrix users of all media reached 160,000+, of which Industrial users accounted for more than 50%, scientific research and clinical users accounted for about 30%, and investment institutions accounted for more than 5%
.
In order to promote interactive exchanges in industry segments, we have established a number of professional WeChat groups, welcome to scan the QR code to add groups
.
