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On the 23rd, Roche announced that the US FDA has approved Susvimo, a unique intraocular drug delivery system, for the treatment of patients with wet age-related macular degeneration (AMD)
.
The press release states that this is the first wet AMD approved by the FDA that may only require treatment twice a year
Susvimo implants a transplant in the patient's eye that can be regularly refilled with medication
.
It is about the same size as a grain of rice and can continuously release the anti-vascular endothelial growth factor (VEGF) antibody ranibizumab for several months
▲Introduction to Susvimo (formerly known as Port Delivery System) (picture source: Roche official website)
Susvimo's approval is just one of many developments in Roche's R&D pipeline this year
.
Roche CEO Mr.
Image source: Roche official website
For blood cancers, Roche’s “first-in-class” antibody-conjugated drug (ADC) Polivy (polatuzumab vedotin) combined with the chemotherapy regimen R-CHP is critical for the first-line treatment of patients with diffuse large B-cell lymphoma (DLBCL) The primary endpoint was reached in the phase 3 clinical trial
.
Compared with the standard treatment R-CHOP, it significantly improves the patient's progression-free survival (PFS)
In addition, the company's two bispecific antibodies targeting CD20 and CD3, glofitamab and mosunetuzumab, are expected to submit regulatory applications early next year and the end of this year, respectively, which may change the standard treatment of non-Hodgkin's lymphoma
.
Image source: Roche official website
Roche's new generation selective estrogen receptor degradant (SERD) giredestrant is a potential "best-in-class" SERD
.
It has a unique mechanism of action, not only can effectively degrade estrogen receptor (ER), but also inhibit the function of ER before degradation, thereby further improving the efficacy
The results of the Phase 2 clinical trial announced at this year’s ESMO conference showed that giredestrant, as a neoadjuvant therapy, combined with the CD4/6 inhibitor palbociclib, will be a biomarker related to tumor proliferation in patients with early ER-positive and HER2-negative breast cancer.
The level of Ki67 was reduced by 80%, which was significantly better than the active control group (67%, p=0.
0222)
.
Moreover, 25% of tumors showed complete cell cycle arrest in the second week of treatment, compared with 5.
▲Giredestrant, as a neoadjuvant therapy, has obtained positive phase 2 clinical trial results (picture source: Roche official website)
In the treatment of spinal muscular atrophy (SMA), Roche's oral therapy Evrysdi (risdiplam) has shown efficacy in a variety of SMA patient types
.
In patients 1-60 years old who have received other SMA therapies, Evrysdi more than doubled the level of SMN protein
In addition, Roche is also developing a new generation of SMA therapy
.
The company's GYM329 is a monoclonal antibody that binds to the precursor protein of myostatin
▲Introduction of GYM329 (picture source: Roche official website)
In the treatment of ophthalmic diseases, faricimab, a bispecific therapy targeting Angiopoietin-2 (Ang-2) and Vascular Endothelial Growth Factor-A (VEGF-A), has recently been granted priority review by the US FDA for treatment Wet AMD and diabetic macular edema (DME)
.
In the treatment of Alzheimer's disease, Roche's anti-amyloid antibody gantenerumab has recently received a breakthrough therapy designation granted by the US FDA
.
The company has also advanced bepranemab, an anti-tau protein therapy, to phase 2 clinical development
.
The Elecsys GAAD in vitro diagnostic system developed by Roche has obtained the CE mark certification of the European Union.
It is an in vitro diagnostic system for early diagnosis of hepatocellular carcinoma by combining the patient's gender, age and the level of two blood biomarkers
.
Compared with the use of alpha-fetoprotein (AFP), it shows higher sensitivity and specificity in detecting early liver cancer
.
Globally, 830,000 people die of hepatocellular carcinoma each year.
Early diagnosis may allow patients to receive curative treatment and increase the 5-year survival rate to 80%
.
▲Elecsys GAAD is an in vitro diagnostic algorithm for early detection of liver cancer (picture source: Roche official website)
Reference materials:
[1] Roche Q3 2021 Presentation.
Retrieved October 22, 2021, from https:// Roche reports strong growth in the first nine months – outlook for 2021 raised.
Retrieved October 22, 2021, from https:// Phase III Study Shows Genentech's Polivy Plus R-CHP Is the First Regimen in 20 Years to Significantly Improve Outcomes in Previously Untreated Aggressive Form of Lymphoma Compared to Standard of Care.
Retrieved October 22, 2021, from https://www.
businesswire.
com/news/home/20210808005031/en/Phase-III-Study-Shows-Genentechs-Polivy-Plus-R-CHP-Is-the-First-Regimen-in-20-Years-to-Significantly-Improve- Outcomes-in-Previously-Untreated-Aggressive-Form-of-Lymphoma-Compared-to-Standard-of-Care
[4] FDA approves Roche's Susvimo, a first-of-its-kind therapeutic approach for neovascular or “wet” age-related macular degeneration (nAMD).
Retrieved October 22, 2021, from https:// news-release/2021/10/22/2319366/0/en/FDA-approves-Roche-s-Susvimo-a-first-of-its-kind-therapeutic-approach-for-neovascular-or-wet-age- related-macular-degeneration-nAMD.
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