Roche is again "first" today!

Today, 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 first wet AMD approved by the FDA may require only two treatments per year

Susvimo ​​implants a transplant in the patient's eye that can be regularly refilled with medication

▲Introduction to Susvimo ​​(formerly known as Port Delivery System) (picture source: Roche official website)

▲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 has initiated 14 phase 3 clinical trials, and 17 new molecular entities (NME) are in the critical clinical development stage

Image source: Roche official website

In terms of blood cancer, 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

"Antibody-conjugated drug (ADC) Polivy (polatuzumab vedotin) combined with chemotherapy regimen R-CHP reached the primary endpoint

Image source: Roche official website

Roche's new generation of selective estrogen receptor degradation agent (SERD) giredestrant is a potential "best-in-class" SERD

giredestrant is a potential "best-in-class" SERD

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.

80% reduction

▲Giredestrant, as a neoadjuvant therapy, has obtained positive phase 2 clinical trial results (picture source: Roche official website)

▲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 addition, Roche is also developing a new generation of SMA therapy

GYM329 is a monoclonal antibody that binds to the precursor protein of myostatin

▲Introduction of GYM329 (picture source: Roche official website)

▲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

Roche's anti-amyloid antibody gantenerumab has recently received a breakthrough therapy designation granted by the U.

The Elecsys GAAD in vitro diagnostic system developed by Roche has obtained the CE mark certification of the European Union.

▲Elecsys GAAD is an in vitro diagnostic algorithm for early detection of liver cancer (picture source: Roche official website)

▲Elecsys GAAD is an in vitro diagnostic algorithm for early detection of liver cancer (picture source: Roche official website)

Roche’s Q3 financial report also detailed the company’s operating results for the first nine months of 2021.
Due to space limitations, this article will not introduce them in detail
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Reference materials:

Reference materials:

[1] Roche Q3 2021 Presentation.
Retrieved October 22, 2021, from https:// Roche Q3 2021 Presentation.
Retrieved October 22, 2021, from https:// [2] Roche reports strong growth in the first nine months – outlook for 2021 raised.
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:// [3] 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

[3] 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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[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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