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Innovent has reported the P-III (RESTORE-3) trial data assessing Sycume(teprotumumab N01/IBI311) vs PBO in Chinese pts (n=116) with inactive thyroid eye disease (bilateral CAS ≤ 2 points)
Trial met its 1EP at Wk. 24, showing higher proptosis response rate as compared to PBO (60.4% vs. 23.5%), plus in 2EP, Sycume showed LS Mean change…
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The NMPA has approved Jaypirca (100 & 50mg) as a monotx. for the treatment of adults with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), expanding its use across all lines of therapy & regardless of prior covalent BTK inhibitor treatment
Approval was backed by the P-III trials: BRUIN CLL-313 assessed Jaypirca in 282 pts with treatment-naïve…
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Innovent will grant Spero Therapeutics exclusive rights to develop, research, manufacture, & commercialize SP001 worldwide, excl. Greater China, where Innovent will retain the rights
In return, Innovent will receive an upfront payment & development, regulatory & commercial milestone payments, representing the total deal value of ~$1.1B, plus Innovent will also receive tiered royalties on…
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Innovent has reported the P-III (G-HOPE-001) of arcotatug tavatecan (IBI343/TAK-921) vs investigator-selected therapy in pts with Claudin 18.2 positive, locally advanced unresectable or metastatic G/GEJA who have received ≥2 prior therapies
Trial met its 1EP of improved PFS in the interim analysis & showed a favorable safety profile; data to be published in future…
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The Chinese NMPA has approved Jaypirca (pirtobrutinib) for the treatment of adults with r/r CLL/SLL after ≥1L of systemic therapy incl. a BTK inhibitor
Approval was based on the P-III (BRUIN CLL‑321) study assessing Jaypirca monotx. (200mg, PO, QD) vs investigator’s choice of IdelaR or BR in 238 previously treated pts with r/r CLL/SLL
Trial…
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Innovent & Eli Lilly have entered into a strategic collaboration to advance novel medicines in oncology & immunology
As per the deal, Innovent will advance the programs from discovery through P-II PoC trial in China using its antibody platforms, while Lilly will receive exclusive rights to develop & commercialize the assets globally, excl. Greater…
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The NMPA has approved Innovent's Tabosun (ipilimumab N01 injection or IBI310) + sintilimab for the neoadj. treatment of stage IIB-III resectable microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) colon cancer
Approval was based on the P-III (NeoShot) trial assessing ipilimumab N01 + sintilimab as neoadj. therapy in pts with MSI-H/dMMR colon cancer
Trial met…
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The Chinese NMPA has approved Pecondle (picankibart) for the treatment of mod. to sev. plaque psoriasis (PsO) in adults who are candidates for systematic therapy
Approval was supported by the P-III (CLEAR-1) trial in Chinese pts with mod. to sev. PsO, where picankibart demonstrated significantly higher PASI 90 (1EP; 80.3% vs 2%) & sPGA 0/1…
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The P-III (GLORY-2) trial assessed mazdutide (9mg) plus lifestyle intervention vs PBO in 462 Chinese adults with obesity (BMI ≥30kg/m²), incl. 16% with T2D, with an NDA submission to the NMPA planned in the near term
Trial met its 1EP, showing continuous weight loss with no plateau through Wk. 60, with pts achieving a…
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The US FDA has approved IND application of IBI3032 to initiate P-I trial for cardiometabolic disorders
The P-I trials will be initiated simultaneously in China & the US, with dosing in healthy & overweight or obese participants anticipated to start in H2’25
IBI3032, an oral GLP-1 receptor agonist biased toward the cAMP pathway, showed…

