Tags : Henlius

PharmaShots Weekly Snapshot (Oct 19 – 23, 2020)

Akebia Presents Results of Vadadustat in P-lll INNO2VATE Program for Anemia Due to CKD at ASN Kidney Week Published: Oct 23, 2020 | Tags: Akebia, Results, Vadadustat, P-lll, INNO2VATE Global Study, Anemia, Chronic Kidney Disease Sanifit Presents Results of SNF472 for the Treatment of Vascular Calcification at ASN Kidney Week 2020 Published: Oct 22, 2020 […]Read More

Henlius Signs a License Agreement with Essex to Co-develop HLX04

Shots: Henlius to receive upfront, regulatory, and commercial milestone payments of ~$43M, eligible to receive $30M for every $1B above the first $600M of the cumulative net sales along with 10% royalties on net sales of the therapy Henlius will be responsible for the pre/ clinical development of HLX04, whereas Essex is responsible for regulatory […]Read More

PharmaShots Weekly Snapshot (Sept 28 – Oct 1, 2020)

Sobi & Selecta Report Results of SEL-212 in P-II COMPARE Study for Chronic Refractory Gout Published: Oct 1, 2020 | Tags: Chronic Refractory Gout, COMPARE Study, Important Clinical Improvement, P-II, patients, reports, results, SEL-212, Selecta Biosciences, Sobi 2. Moderna’s mRNA-1273 COVID-19 Vaccine Demonstrate Immune Responses in Older Adults Published: Oct 1, 2020 | Tags: COVID-19, […]Read More

Insights+ Key Biosimilars Events of September 2020

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 the patients. Hence, the providers are more likely to adopt biosimilars as a “reference […]Read More

Henlius Signs an Exclusive License Agreement with Accord for HLX02

Shots:   Henlius to receives $27M up front, ~$13M regulatory milestones, $25M commercial milestones for every $500M of cumulative net sales, and is eligible to receive royalty up to 50% profit of HLX02. If the cumulative net sales of HLX02 reaches $3B, Henlius to receive ~$150M as commercial milestones Accord to get an exclusive license to […]Read More

Henlius Presents P-III Data of HLX04 (biosimilar, bevacizumab) at CSCO

Shots: The P-III HLX04-mCRC03 study involve assessing of HLX04 (7.5mg/kg, q3w, when combined with XELOX or 5mg/kg, q2w when combined with mFOLFOX6) vs reference bevacizumab + CT (XELOX or mFOLFOX6) as a 1L treatment in 675 patients in a ratio (1:1) with mCRC Results: PFSR36wk  (46.4% vs 50.7%); no difference in 2EPs including OS, PFS, ORR, […]Read More

Henlius Present P-III Data of HLX02 (biosimilar, trastuzumab) at ESMO

Shots: The P-III HLX02-BC01 study involves assessing HLX02 vs EU-sourced trastuzumab in combination with docetaxel in a 3wks. cycle for up to 1yr. in patients in a ratio (1:1) with HER2-positive recurrent/ mBC, prior not treated with systemic treatment   Results:  Per ITT set, ORRwk24 (71.3% vs 71.4%); Per PP set, ORRwk24 (74.2% vs 73.2%); […]Read More

PharmaShots Weekly Snapshot (Sept 07 -11, 2020)

1. Janssen’s Tremfya (guselkumab) Receives the US FDA’s Approval as the First Selective IL-23 Inhibitor for Active Psoriatic Arthritis Published: Sept 10, 2020 | Tags:  Janssen, Tremfya, Guselkumab, Biologic, US FDA, Selective, IL-23 inhibitor, Active Psoriatic Arthritis, Severe Plaque Psoriasis, human mAb 2. Janssen Reports sBLA Submission to the US FDA for Darzalex Faspro (daratumumab […]Read More

Henlius Reports NMPA’s Acceptance of NDA for HLX04 (biosimilar, bevacizumab)

Shots: NMPA has accepted the NDA of HLX04, based on the series of study data, including comparative pharmaceutical quality studies, comparative non-clinical studies & clinical studies. The NDA acceptance makes HLX04 the fourth product of Henlius that has received NMPA’s NDA acceptance & can be potentially used for the treatment of advanced/ metastatic or recurrent […]Read More