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With the development of China's pharmaceutical technology and the increase in R&D investment of enterprises, the innovation strength of domestic pharmaceutical companies has been continuously improved, and more and more domestic drugs have gone overseas
.
Recently, although the news of the setback in the overseas listing application of domestic PD-1 inhibitors has shrouded the pharmaceutical circle, on the whole, domestic drugs are still riding the wind and waves and accelerating their entry into the overseas market
.
Legend Bio: CAR-T therapy approved by FDA Legend Bio recently announced that the Biologics License Application (BLA) for its self-developed CAR-T therapy cilta-cel was officially approved by the FDA for use in Treatment of patients with relapsed/refractory multiple myeloma (r/r MM)
.
This is also the first domestic CAR-T cell therapy approved by the FDA and will enter the US market
.
Legend Bio and Janssen announced their partnership in December 2017 to jointly commercialize Cidaki Olenx
.
According to reports, starting in 2022, the two pharmaceutical companies will launch a network of certified treatment centers in stages to expand production capacity and increase the availability of drugs across the United States to ensure that they are provided to oncologists and patients in a reliable and timely manner
.
It is worth mentioning that CAR-T is expensive or a major challenge in the commercialization process
.
It is reported that the price of Cidaki Orenza is 465,000 US dollars per injection, which is higher than the previously approved price of the same-targeted CAR-T product Abecma, which is 438,000 US dollars per injection
.
Some industry analysts predict peak sales of Abecma will be about $2 billion, and peak sales of Cedar Keorenza will be about $500 million
.
Analysts pointed out that there are currently only about 450,000 patients with multiple myeloma in the world, and CAR-T therapy has obvious advantages over traditional therapy
.
It also believes that although the product is expensive, it is also within the reasonable range of CAR-T therapy
.
BeiGene: Baiyueze Approved in Switzerland Macroglobulinemia (WM) in adults, or as first-line treatment for WM patients who are not suitable for chemoimmunotherapy
.
The drug has previously been granted "orphan drug" designation
.
It is reported that as of now, Baiyueze has obtained more than 20 approvals in 44 markets, covering the United States, China, Canada, Australia and other countries and regions
.
In addition, it has more than 40 drug regulatory filings under review worldwide
.
Antengene: XPOVIO(R) is approved for listing in Singapore In addition to self-developed products, there are also good news that some products introduced by local pharmaceutical companies have been approved in overseas markets recently
.
For example, Antengene recently announced that the company's product XPOVIO® (Selinisol) has been approved by the Singapore Health Sciences Authority (HSA) for the treatment of three indications, namely: relapsed and refractory multiple myeloid Tumor (R/RMM) – Selinexol in combination with bortezomib and dexamethasone in patients with R/RMM who have received at least 1 prior therapy; relapsed refractory multiple myeloma (R/RMM) – Selinenib dexamethasone combined with dexamethasone in adult patients with R/RMM who have received at least 4 prior therapies and are refractory to at least two proteasome inhibitors, two immunomodulators, and one anti-CD38 monoclonal antibody; relapsed and refractory Diffuse large B-cell lymphoma (R/RDLBCL) – Selinexor monotherapy is indicated for the treatment of adult patients with R/RDLBCL who have received at least 2 prior therapies and are ineligible for hematopoietic stem cell transplantation
.
The approval of these indications will bring new treatment options to relevant local patients
.
Antengene said that the company's commercialization team is ready and will start to fully promote this new drug in Singapore based on the experience of XPOVIO® in China and South Korea
.
It is understood that Celinisol was developed by Karyopharm Therapeutics, and Antengene Pharmaceuticals obtained relevant commercialization rights through the introduction. .
At present, in addition to Singapore, the product has been approved for new drug marketing applications in China and South Korea
.
.
Recently, although the news of the setback in the overseas listing application of domestic PD-1 inhibitors has shrouded the pharmaceutical circle, on the whole, domestic drugs are still riding the wind and waves and accelerating their entry into the overseas market
.
Legend Bio: CAR-T therapy approved by FDA Legend Bio recently announced that the Biologics License Application (BLA) for its self-developed CAR-T therapy cilta-cel was officially approved by the FDA for use in Treatment of patients with relapsed/refractory multiple myeloma (r/r MM)
.
This is also the first domestic CAR-T cell therapy approved by the FDA and will enter the US market
.
Legend Bio and Janssen announced their partnership in December 2017 to jointly commercialize Cidaki Olenx
.
According to reports, starting in 2022, the two pharmaceutical companies will launch a network of certified treatment centers in stages to expand production capacity and increase the availability of drugs across the United States to ensure that they are provided to oncologists and patients in a reliable and timely manner
.
It is worth mentioning that CAR-T is expensive or a major challenge in the commercialization process
.
It is reported that the price of Cidaki Orenza is 465,000 US dollars per injection, which is higher than the previously approved price of the same-targeted CAR-T product Abecma, which is 438,000 US dollars per injection
.
Some industry analysts predict peak sales of Abecma will be about $2 billion, and peak sales of Cedar Keorenza will be about $500 million
.
Analysts pointed out that there are currently only about 450,000 patients with multiple myeloma in the world, and CAR-T therapy has obvious advantages over traditional therapy
.
It also believes that although the product is expensive, it is also within the reasonable range of CAR-T therapy
.
BeiGene: Baiyueze Approved in Switzerland Macroglobulinemia (WM) in adults, or as first-line treatment for WM patients who are not suitable for chemoimmunotherapy
.
The drug has previously been granted "orphan drug" designation
.
It is reported that as of now, Baiyueze has obtained more than 20 approvals in 44 markets, covering the United States, China, Canada, Australia and other countries and regions
.
In addition, it has more than 40 drug regulatory filings under review worldwide
.
Antengene: XPOVIO(R) is approved for listing in Singapore In addition to self-developed products, there are also good news that some products introduced by local pharmaceutical companies have been approved in overseas markets recently
.
For example, Antengene recently announced that the company's product XPOVIO® (Selinisol) has been approved by the Singapore Health Sciences Authority (HSA) for the treatment of three indications, namely: relapsed and refractory multiple myeloid Tumor (R/RMM) – Selinexol in combination with bortezomib and dexamethasone in patients with R/RMM who have received at least 1 prior therapy; relapsed refractory multiple myeloma (R/RMM) – Selinenib dexamethasone combined with dexamethasone in adult patients with R/RMM who have received at least 4 prior therapies and are refractory to at least two proteasome inhibitors, two immunomodulators, and one anti-CD38 monoclonal antibody; relapsed and refractory Diffuse large B-cell lymphoma (R/RDLBCL) – Selinexor monotherapy is indicated for the treatment of adult patients with R/RDLBCL who have received at least 2 prior therapies and are ineligible for hematopoietic stem cell transplantation
.
The approval of these indications will bring new treatment options to relevant local patients
.
Antengene said that the company's commercialization team is ready and will start to fully promote this new drug in Singapore based on the experience of XPOVIO® in China and South Korea
.
It is understood that Celinisol was developed by Karyopharm Therapeutics, and Antengene Pharmaceuticals obtained relevant commercialization rights through the introduction. .
At present, in addition to Singapore, the product has been approved for new drug marketing applications in China and South Korea
.
