Transcenta Holding

Transcenta Holding (HKEX: 6628) is a clinical-stage biopharmaceutical company with integrated capabilities spanning biologics discovery, translational research, process development, clinical development and manufacturing. Headquartered in Suzhou, China, it describes itself as a global fully integrated biotherapeutics company and reports a pipeline of more than ten (site figures cite 16 pipeline programs) therapeutic antibody candidates across oncology and selected non-oncology indications, principally bone and kidney disorders.

The oncology portfolio is led by Osemitamab (TST001), a Claudin 18.2-targeting monoclonal antibody in development for gastric/gastroesophageal junction cancer and other solid tumors, studied both in combination with PD-1 inhibitors plus chemotherapy and with chemotherapy alone. Other oncology assets include TST005 (PD-L1 x TGF-beta bispecific antibody), TST003 (Gremlin-1 mAb for colorectal and prostate cancers), TST013 (LIV-1 ADC), TST105 (FGFR2b-X bispecific ADC), TST106 (Claudin 18.2-X bispecific ADC), TST198 (Claudin 18.2 radioconjugate), TST786 (PD1-VEGF and Gremlin-1 trispecific), MSB2311 (pH-dependent PD-L1 antibody) and Ozekibart, a DR5 agonist antibody licensed for Greater China from Inhibrx. Non-oncology programs include Blosozumab (TST002), a sclerostin antibody in-licensed from Eli Lilly for Greater China for osteoporosis; TST004 (MASP-2 mAb for IgAN and TMA, co-developed with Alebund in Greater China); and preclinical BAFF/APRIL-directed candidates TST801, TST808 and TST008 for autoimmune disease and IgAN.

The company's discovery engine is its proprietary Immune Tolerance Breaking Technology (IMTB) antibody generation platform, complemented by a next-generation continuous/perfusion bioprocessing platform (HiCB) intended to raise productivity and lower cost of goods. Transcenta also reports CDMO business activity and out-licensing of its HiCB platform.

Founding story

Transcenta was formed in January 2019 through the merger of MabSpace Biosciences and HJB. MabSpace, founded in 2013 (the company's own milestone timeline dates the establishment of Mabspace Biosciences (Suzhou), now Suzhou Transcenta Therapeutics, to 2012), was a Hong Kong-headquartered, Suzhou-based clinical-stage antibody discovery and development company with a roughly 60-person team and a 50,000 sq ft facility in Biobay, Suzhou Industrial Park; it developed the Immune Tolerance Breaking Technology platform. HJB, founded in 2016 with sites in Shanghai, Hangzhou and Boston and over 100 staff, focused on innovative bioprocessing and operated a 140,000 sq ft POD-based manufacturing facility using continuous processing technology. Co-founders Xueming Qian (former MabSpace founder, chairman and CEO) and Jonathan Yining Zhao (HJB co-founder and CEO) had previously worked together at Amgen; Qian became CEO of the combined company and Zhao executive chairman. Qian has said the merger was motivated by MabSpace's lack of in-house CMC control and HJB's lack of discovery capability, and that the name reflects an intent to 'transcend' what other companies had accomplished.

Business model

Transcenta develops proprietary antibody-based therapeutics for global markets while operating its own process development and GMP manufacturing capacity. It combines in-house discovery with in-licensing of external assets (for example Blosozumab from Eli Lilly for Greater China and Ozekibart from Inhibrx for Greater China) and partnering/co-development arrangements. It also makes its manufacturing platform available to third parties, reporting CDMO business and out-licensing milestone payments for the HiCB platform.

Sources indicate revenue-generating activity from CDMO services and out-licensing of the HiCB manufacturing platform, including a reported HiCB out-licensing milestone payment; no revenue figures are disclosed in the sources.

Traction

The company reports 16 pipeline programs and 139 issued and pending patents. Clinical progress includes multiple IND clearances from FDA and NMPA, two FDA orphan drug designations for Osemitamab (G/GEJ cancer in 2021 and pancreatic cancer in 2023), and repeated data presentations at AACR, ASCO, ESMO, ESMO Asia and SABCS covering Osemitamab combination trials (including the Phase I/II Transtar102 trial with nivolumab and CAPOX), TST003, TST013 (LIV-1 ADC) and an FGFR2b-targeting ADC. Prior to the December 2020 crossover round the company reported having raised over $347 million cumulatively.

Latest developments

The company's milestone timeline lists 2024 items including an Agilent collaboration on a Claudin 18.2 companion diagnostic supporting a global Phase III trial of Osemitamab, AACR 2024 data for Osemitamab and TST003, Phase II first-line triple-combination data for Osemitamab in G/GEJ cancer at ASCO 2024 and updated data at ESMO 2024, and LIV-1 ADC preclinical data at SABCS 2024. For 2025 it lists preclinical FGFR2b ADC data at AACR 2025, overall survival data from the first-line triple combination trial at ASCO 2025, and updated Transtar102 data at ESMO Asia. Entries listed under 2026 include the appointment of Dr. Christopher Hwang as Head of Global Partnerships for the HiCB platform, reported progress for Osemitamab in pancreatic cancer and updated TST013 data at AACR, receipt of a HiCB out-licensing milestone payment alongside CDMO business growth, and a strategic collaboration with WuXi Biologics.