HRS-8080 Tablet ; Dalpiciclib Isethionate — Competitive Intelligence Brief

HRS-8080 Tablet ; Dalpiciclib Isethionate (HRS-8080 Tablet ; Dalpiciclib Isethionate) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: CDK4/6 inhibitor. Area: Oncology.

phase 3 CDK4/6 inhibitor CDK4/6 Oncology Small molecule

Target snapshot

HRS-8080 Tablet ; Dalpiciclib Isethionate (HRS-8080 Tablet ; Dalpiciclib Isethionate) — Shandong Suncadia Medicine Co., Ltd.. Dalpiciclib is a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor that blocks cell cycle progression by preventing phosphorylation of the retinoblastoma protein.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
HRS-8080 Tablet ; Dalpiciclib Isethionate TARGET	HRS-8080 Tablet ; Dalpiciclib Isethionate	Shandong Suncadia Medicine Co., Ltd.	phase 3	CDK4/6 inhibitor	CDK4/6
Ibrance	Palbociclib	Pfizer	marketed	CDK4/6 inhibitor	Cyclin-dependent kinases 4 and 6 (CDK4/6)	2015-01-01
Palbociclib	palbociclib	Pfizer Inc.	marketed	CDK4/6 inhibitor	Cyclin-dependent kinases 4 and 6 (CDK4/6)
Palbociclib in combination with AI	palbociclib-in-combination-with-ai	Pfizer	marketed	CDK inhibitor	CDK4/6
target treatment	target treatment	Institut Bergonié	marketed	CDK4/6 inhibitor	CDK4/6
Abemaciclib + Aromatase Inhibitor	Abemaciclib + Aromatase Inhibitor	Prof. Wolfgang Janni	marketed	CDK4/6 inhibitor + Aromatase inhibitor combination	CDK4/6 + Aromatase
Abemaciclib + Fulvestrant	Abemaciclib + Fulvestrant	Prof. Wolfgang Janni	marketed	CDK4/6 inhibitor + estrogen receptor antagonist	CDK4/6 and estrogen receptor (ER)

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (CDK4/6 inhibitor class)

1. AstraZeneca · 1 drug in this class
2. Centre Leon Berard · 1 drug in this class
3. Draig Therapeutics Ltd · 1 drug in this class
4. Fujian Cancer Hospital · 1 drug in this class
5. GBG Forschungs GmbH · 1 drug in this class
6. GERCOR - Multidisciplinary Oncology Cooperative Group · 1 drug in this class
7. Hoffmann-La Roche · 1 drug in this class
8. Institut Bergonié · 1 drug in this class
9. Jiangsu Simcere Pharmaceutical Co., Ltd. · 1 drug in this class
10. Kartos Therapeutics, Inc. · 1 drug in this class