Home Novatim Pharma Licenses First-in-Class EGFR/c-MET Nanobody Bispecific ADC KY-0301 for Over $1.1 Billion; Roche Expands IBD Pipeline via Genentech Collaboration

Novatim Pharma Licenses First-in-Class EGFR/c-MET Nanobody Bispecific ADC KY-0301 for Over $1.1 Billion; Roche Expands IBD Pipeline via Genentech Collaboration

Sep 02, 2025 19:14 CST Updated 19:14
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Roche's New Move.


On September 2, OMass Therapeutics announced that it had entered into an exclusive collaboration and licensing agreement with Genentech, a member of the Roche Group, granting the latter rights to develop and commercialize OMass’s preclinical oral small molecule program targeting inflammatory bowel disease (IBD). OMass is a biotechnology company focused on developing drugs for highly validated target ecosystems such as membrane proteins or intracellular complexes.


Another domestically produced ADC goes overseas.


Recently, Novatim announced an exclusive licensing partnership with RADIANCE Biopharma. Novatim has granted RADIANCE the overseas development, registration, and commercialization rights for KY-0301, the world’s first nano bispecific ADC drug.


First China-produced Denosumab biosimilar launched in the US.


September 2,Henlius Announces,The U.S. Food and Drug Administration (FDA) has approved BILDYOS® and BILPREVDA®, two biosimilars co-developed with Organon, which are the generic versions of Prolia® (denosumab) and Xgeva® (denosumab), respectively.


In the past day, what are the hot topics in the pharmaceutical markets at home and abroad that are worth paying attention to? Let Amino take you to explore.


/ 01 /

Market Express


1) Novatim's EGFR/c-MET Nano Bispecific ADC Authorized for Overseas Use


Recently, Novatim announced an exclusive licensing partnership with RADIANCE Biopharma. Novatim has granted RADIANCE the overseas development, registration, and commercialization rights for KY-0301, the world’s first nano bispecific antibody-drug conjugate (ADC).


/ 02 /

Pharmaceutical News


1) Amgen's AMG 133 Receives Clinical Approval


On September 2, according to the CDE official website, Amgen's AMG 133 has been granted clinical approval for use in reducing cardiovascular (CV) risk in adults with atherosclerotic cardiovascular disease (ASCVD) who are obese or overweight.


2) Haisco HSK47388 Tablets Obtain Clinical Approval


On September 2, according to the CDE official website, Haisco's HSK47388 tablets received clinical approval and are intended for research on inflammatory bowel disease (including ulcerative colitis and Crohn's disease).


3) InnoCare's ICP-332 Tablets Receive Clinical Approval


On September 2, according to the CDE website, InnoCare's ICP-332 tablets received clinical approval for the study of prurigo nodularis.


4) Tongrui Biotech's 64Cu-TR2205 Injection Receives Clinical Approval


On September 2, according to the CDE official website, Tongrui Biotech's 64Cu-TR2205 Injection received clinical approval for the diagnosis of adult patients with PSMA-positive recurrent metastatic prostate cancer.


5) DuoXi Bio's Injectable DXC014 Receives Clinical Approval


On September 2, according to the CDE website, DuoXi Biologics' injectable DXC014 received clinical approval for the intended research on advanced solid tumors.


6) Baili Pharmaceuticals' Injectable BL-B01D1 Granted Breakthrough Therapy Designation


On September 2, according to the CDE official website, Baili Pharmaceutical's injectable BL-B01D1 is proposed to receive breakthrough therapy designation for use in patients with platinum-resistant recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.


7) Henlius Biosimilar Approved by FDA


September 2,Henlius Announces,The U.S. Food and Drug Administration (FDA) approved BILDYOS® and BILPREVDA®, two biosimilars co-developed with Organon, which are the generic versions of Prolia® (denosumab) and Xgeva® (denosumab), respectively.


/ 03 /

Overseas Pharma News


1) Roche doubles down on IBD field


On September 2, OMass Therapeutics announced that it had entered into an exclusive collaboration and licensing agreement with Genentech, a member of the Roche Group, granting the latter rights to develop and commercialize OMass's preclinical oral small molecule program targeting inflammatory bowel disease (IBD). OMass is a biotechnology company focused on developing drugs for highly validated target ecosystems such as membrane proteins or intracellular complexes.




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