November 10 | Issue 4

UltraDx Bio is announcing the first round of closing of nearly 100 mm RMB funding from world renowned VCs such as ARCH and GF Hong Kong.

2023-11-08

"With full joy and passion, I am announcing that we make a significant step towards our mission to make the world a healthier planet by aligning cutting-edge SIMOA technology from Quanterix, blue ocean markets, and resources and funds, with our first closing of funding. We are committed to working with leading scientists and clinicians to advance the early diagnosis of AD and other neurodegenerative diseases, cancers, cardiovascular, inflammatory, infectious diseases, etc., so as to enable early treatment and intervention.” said Jay Dong, Founder and CEO of UltraDx.

FDA Grants GFH009 with Fast Track Designation Treating R/R PTCL

2023-11-02

GenFleet Therapeutics, a clinical-stage biotechnology company developing cutting-edge therapies in oncology and immunology, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) for SLS009 (GFH009) for the treatment of adult patients with relapsed/refractory (r/r) peripheral T-cell lymphomas (PTCL). This designation was supported by data from the phase I, multi-center trial of GFH009 (highly selective CDK9 inhibitor) which met all key study objectives. Earlier in October, GFH009 was granted with FDA’s Orphan Drug Designation for the treatment of acute myeloid leukemia (AML).

Junshi Biosciences's Anti-PD-1 Monoclonal Antibody "toripalimab" Approved for Marketing by U.S. FDA

2023-10-30

Coherus BioSciences and Junshi Biosciences announced that the US FDA has approved their monoclonal antibody drug, Loqtorzi (Toripalimab, also known as TUOYI® or JS001), in combination with gemcitabine and cisplatin, as a first-line treatment for patients with advanced, recurrent or metastatic nasopharyngeal carcinoma (NPC). The drug has also been approved as a monotherapy for the second-line or later treatment of recurrent or metastatic NPC after platinum-containing chemotherapy. According to the press release, Toripalimab is the first drug approved by the FDA for the treatment of nasopharyngeal carcinoma.

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