Shots:
Minghui has granted Qilu exclusive rights to develop, manufacture & market MHB088C in Greater China (incl. Mainland China, Hong Kong, Macau, & Taiwan)
As per the deal, Minghui will receive ~$185.9M (CN¥ 1.345B) incl. $38.7M as upfront & near-term milestone payments & ~$147.2M in development, regulatory & sales milestones, plus double-digit net sales-based royalties;…
Shots:
VERAXA Biotech has entered into a co-discovery alliance with OmniAb to develop novel bispecific antibody drug conjugate (bsADC) targeting solid tumors using the former’s ADC linker tech & conjugation expertise & OmniAb’s suite of transgenic antibody discovery solutions
As per the deal, VERAXA will initiate novel bsADC program targeting 2 cancer-related molecules, using OmniAb’s…
Shots:
China’s NMPA has received 2 IND applications for HF158K1 (K1) & HFK2 (K2) to initiate P-I dose escalation trial in China to evaluate safety & PK of K1 alone & its preliminary efficacy with K2 to treat pts with solid tumors refractory to prior therapies
Preclinical studies of K1, K2, & their combination showed…
Shots:
The US FDA has granted full approval to Vitrakvi for adults & pediatrics with NTRK fusion-positive metastatic or inoperable solid tumors, who had disease progression on prior therapy or lacked alternative therapy options
Approval was based on 3 trials: LOXO-TRK-14001, SCOUT, & NAVIGATE, evaluating Vitrakvi in 339 adult & pediatric pts. Key EPs were…
Shots:
BBOT has reported first pts dosing in its P-I (KONQUER-101) trial assessing BBO-11818 for advanced solid tumors, with trial enrolling pts globally
In cellular assays, BBO-11818 showed pERK inhibition in selected KRAS G12D & G12V-mutant cell lines at lower concentrations, while reducing viability in KRAS G12D/G12V/G12C mutant cells & exhibiting >500-fold selectivity for KRAS…
Shots:
NANOBIOTIX & Janssen have amended their 2023 collaboration to develop & commercialize JNJ-1900 (NBTXR3), adjusting the deal value from $2.7B to $2.6B
As per the revision, NANOBIOTIX will receive ~$1.77B in milestones related to cisplatin-ineligible HNSCC & inoperable stage 3 NSCLC, with ~$165M in milestones for China, South Korea, Singapore, & Thailand. J&J will cover…
Shots:
Avenzo Therapeutics and DualityBio have signed an exclusive license agreement to develop, manufacture & commercialize the former’s AVZO-1418/DB-1418 across the globe (excl. Greater China)
As per the terms, DualityBio will get $50M upfront, ~$1.15B development, regulatory and commercial milestones as well as tiered royalties in Avenzo’s territory
AVZO-1418, an EGFR/HER3-targeting ADC developed…
Shots:
Hanx Biopharmaceuticals has dosed the first patient with HX044 under its P-I clinical evaluation for treating solid tumors
The dose escalation & expansion P-I/IIa (HX044-I-01) trial will assess safety, tolerability, PK profile & initial efficacy of HX044 for the treatment of advanced solid tumor malignancies
HX044 is a first-in-class bispecific antibody and…
Shots:
Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency
Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients
The major highlights were the US FDA’s approval of Samsung Bioepis and…
Shots:
The NMPA has cleared IND application of HLX17 to conduct its clinical study in comparison with Keytruda for treating melanoma, NSCLC, esophageal cancer, HNSCC, CRC, HCC, biliary tract cancer, TNBC, MSI-H/dMMR cancer & gastric cancer
HLX17 was assessed under pharmacologic comparative trial, preclinical pharmacology study as well as PK/PD & immunogenicity studies that showed similarity…

