Akeso’s Cadonilimab Receives the NMPA’s Approval for 1L Treatment of Cervical Cancer

Shots: The NMPA has approved cadonilimab + Pt-based CT ± Avastin as a 1L treatment of persistent, recurrent, or metastatic cervical cancer Approval was based on the P-III (COMPASSION-16) trial assessing cadonilimab vs SoCs, which met its PFS & OS endpoints, showing efficacy in PD-L1-negative tumors (CPS <1; 27.9% vs 24.2%) with subgroup analyses demonstrating benefit…

ByRidhi RastogiJune 5, 2025

News

Akeso’s Penpulimab-kcqx Receives the US FDA’s Approval for Nasopharyngeal Carcinoma (NPC)

Shots: The US FDA has approved penpulimab-kcqx + CT (cisplatin/carboplatin + gemcitabine) as 1L treatment for recurrent or metastatic non-keratinizing NPC in adults, & as monotx. for those with metastatic non-keratinizing NPC progressing on/after Pt-based CT & ≥1L prior therapy Approval was supported by 2 BLA submissions based on international P-III (AK105-304) trial & pivotal…

ByDipanshu DixitApril 25, 2025

News

China’s NMPA Approves Akeso’s Ebdarokimab (IL-12/IL-23 Dual-Targeted mAb) for Moderate to Severe Plaque Psoriasis

Shots: Akeso’s ebdarokimab has received NMPA approval for the treatment of moderate-to-severe plaque psoriasis in adult Clinical study showed strong efficacy and safety of ebdarokimab (135mg) two doses at weeks 0 and 4, with a PASI 75 response rate of 79.4% at 16wks. and ebdarokimab Q12W 77.9% at 52wks. along with significant improvements in patients'…

ByRidhi RastogiApril 18, 2025

News

Akeso Reports First Patient Enrollment in P-III Study of Ivonescimab + CT to Treat Triple-Negative Breast Cancer (TNBC) in China

Shots: Akeso enrolled the first patient in the P-III (HARMONi-BC1/AK112-308) study of Ivonescimab + CT for the treatment of unresectable locally advanced or metastatic TNBC (already approved for EGFR-TKI-resistant, non-squamous NSCLC in China) The preliminary efficacy data presented at ESMO’24 showed significant therapeutic efficacy of ivonescimab + CT and a favorable safety profile for…

ByRidhi RastogiFebruary 21, 2025

News

Akeso Completes Patient Enrollment in P-III (HARMONi-6/AK112-306) Trial of Ivonescimab for Squamous NSCLC

Shots: Akeso has completed patient enrollment in the global P-III (HARMONi-6/AK112-306) trial (1/6 P-III trials) assessing ivonescimab + Pt-based CT vs Tevimbra + Pt-based CT to treat 1L squamous NSCLC in China Multiple P-III trials are underway, incl. HARMONi-3 (vs Keytruda + CT) in 1L sq- & non-sq NSCLC (led by Summit Therapeutics), plus trials…

ByRidhi RastogiFebruary 6, 2025

News

China’s NMPA Accepts NDA for Akeso’s Gumokimab to Treat Moderate to Severe Psoriasis

Shots: China’s NMPA has accepted an NDA for gumokimab (AK111) to treat mod. to sev. plaque psoriasis based on the P-III (AK111-301) trial & 3 supportive studies, showing rapid improvement in 2wks. Data showed short-term efficacy, with a PASI 75 response rate approaching 96% & an sPGA 0/1 response nearing 90%. PASI 90 hit ~80%, &…

ByRidhi RastogiJanuary 27, 2025

INSIGHTS+

PharmaShots’ Key Highlights of Fourth Quarter 2022

Shots: The fourth quarter of 2022 highlights approvals, multiple clinical trial results, and numerous deals. There are major alliances in this quarter which include Johnson & Johnson acquired Abiomed for ~$16.6B, Takeda entered into an agreement to acquire NDI-034858 from Nimbus Therapeutics for ~$6B In the fourth quarter of the year, BeiGene’s Brukinsa received EC’s…

BySenior EditorDecember 29, 2022

Akeso’s Cadonilimab Receives the NMPA’s Approval for 1L Treatment of Cervical Cancer

Akeso’s Penpulimab-kcqx Receives the US FDA’s Approval for Nasopharyngeal Carcinoma (NPC)

China’s NMPA Approves Akeso’s Ebdarokimab (IL-12/IL-23 Dual-Targeted mAb) for Moderate to Severe Plaque Psoriasis

Akeso Reports First Patient Enrollment in P-III Study of Ivonescimab + CT to Treat Triple-Negative Breast Cancer (TNBC) in China

Akeso Completes Patient Enrollment in P-III (HARMONi-6/AK112-306) Trial of Ivonescimab for Squamous NSCLC

China’s NMPA Accepts NDA for Akeso’s Gumokimab to Treat Moderate to Severe Psoriasis

PharmaShots’ Key Highlights of Fourth Quarter 2022

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Akeso’s Cadonilimab Receives the NMPA’s Approval for 1L Treatment of Cervical Cancer

Akeso’s Penpulimab-kcqx Receives the US FDA’s Approval for Nasopharyngeal Carcinoma (NPC)

China’s NMPA Approves Akeso’s Ebdarokimab (IL-12/IL-23 Dual-Targeted mAb) for Moderate to Severe Plaque Psoriasis

Akeso Reports First Patient Enrollment in P-III Study of Ivonescimab + CT to Treat Triple-Negative Breast Cancer (TNBC) in China

Akeso Completes Patient Enrollment in P-III (HARMONi-6/AK112-306) Trial of Ivonescimab for Squamous NSCLC

China’s NMPA Accepts NDA for Akeso’s Gumokimab to Treat Moderate to Severe Psoriasis

PharmaShots’ Key Highlights of Fourth Quarter 2022

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