TRANSCENTA HOLDING - A Global Fully Integrated Biotherapeutics Company

Transcenta, Biologics, Antibody, Claudin 18.2

TRANSCENTA HOLDING - A Global Fully Integrated Biotherapeutics Company

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COMPANY PROFILE

Transcenta is a clinical stage biopharmaceutical company that fully integrates antibody-based biotherapeutics discovery, research, development and manufacturing. On September 29, 2021, Transcenta was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 06628. 


Transcenta has established global footprint, with Headquarters and Discovery, Clinical and Translational Research Center in Suzhou, Process and Product Development Center and Manufacturing Facility in Hangzhou, and Clinical Development Centers in Beijing, Shanghai and Guangzhou in China and in Princeton, US, and Business Development in Boston and LA, US. Transcenta is developing thirteen therapeutic antibody molecules for oncology and selected non-oncology indications including bone and kidney disorders.

Mission

Employing cutting-edge technology, we innovate to help patients with differentiated and affordable biologics.

Leadership

SENIOR MANAGEMENT SENIOR MANAGEMENT
BOARD OF DIRECTORS BOARD OF DIRECTORS
SCIENTIFIC ADVISORY BOARDS SCIENTIFIC ADVISORY BOARDS

MILESTONES

2024

2012

2013

2016

2018

2019

2020

2021

2022

2023

2024

Collaborating with Agilent to develop a Claudin 18.2 companion diagnostic to support Osemitamab (TST001) global phase III trial

Debuted encouraging Phase II data from first-line triple combo trial of Osemitamab (TST001) for G/GEJ Cancer at ASCO 2024

2012

Established Mabspace Biosciences (Suzhou) (Now renamed as Suzhou Transcenta Therapeutics Co., Ltd.)

2013

Developed the Immune Tolerance Breaking Technology Platform (IMTB)

2016

Established HJB (Hangzhou) Co., Ltd.

2018

Obtained MSB2311 IND clearance from FDA and NMPA

HJB Launched Process and Product Development Center and Manufacturing Facility in Hangzhou

2019

Mabspace & HJB merged to establish Transcenta

In-licensed Blosozumab (TST002)

Obtained MSB0254 IND clearance from NMPA

2020

Obtained Osemitamab (TST001) IND clearance from NMPA and FDA

First patient dosed in Phase I clinical trial of Osemitamab (TST001) in US

Formed collaboration with Merck to co-develop continuous downstreaming manufacturing technology

Formed JV with Alebund for co-development of TST004 for renal disease in China

2021

Obtained TST005 IND clearance from FDA

First patient dosed in Phase I clinical study of Osemitamab (TST001) combined with CAPOX

First patient dosed in global Phase I clinical trial of TST005 in US

FDA Granted ODD to Osemitamab (TST001), for the treatment of G/GEJ Cancer

Held investigator meeting and first patient dosed in Phase IIa clinical trial of Osemitamab (TST001) in China

HKEX Listing (Stock Code: 6628) on Sept 29th

Obtained TST002 IND clearance from NMPA

First patient dosed in Phase Ib clinical trial of MSB0254

Obtained TST005 IND clearance from NMPA

2022

First patient dosed in Phase IIa clinical trial of Osemitamab (TST001) combined with CG for BTC

Global clinical collaboration with BMS to evaluate Osemitamab (TST001) in combination with Opdivo

First patient dosed in China Phase I clinical trial of TST002

Nature Cancer published the study results by Transcenta and Shanghai Jiaotong University scientists on the potential application of TST003 in the treatment of androgen receptor-negative/low

Released Phase I clinical data of Osemitamab (TST001) in combination with CAPOX as the first line treatment of advanced and metastatic G/GEJ cancer at ASCO 2022

Presented the preclinical data of TST004 at the 2022 ISN frontiers meetings of complement related kidney diseases

Presented interim safety and efficacy data of the Osemitamab (TST001) and chemotherapy combination expansion cohort for claudin18.2 positive first line gastric cancer at ESMO congress 2022

Obtained TST003 and TST004 IND clearance from FDA

2023

Obtained TST003 IND clearance from NMPA

Study results of CLDN18.2-targeting Immuno-PET Probe for non-invasive imaging in gastrointestinal tumors have been published on Journal of Pharmaceutical Analysis

First patient dosed in the US Phase I clinical trial of TST003

FDA Granted ODD to Osemitamab (TST001), for the treatment of Pancreatic Cancer

Completed Enrollment in Cohorts C and G of China Phase II Clinical Study of Osemitamab (TST001) in Combination with CAPOX with or without Nivolumab as First-line Treatment of G/GEJ Cancer Patients

Released encouraging Phase I clinical data of TST002 in Chinese patients with reduced bone mineral density

Presented updated data of Osemitamab (TST001) in combination with CAPOX as a first-line treatment of G/GEJ cancer at ASCO and ESMO GI

Received approvals from China CDE, South Korea MFDS and FDA to initiate TranStar 301 global Phase III pivotal trial of Osemitamab (TST001)

Received approval from CDE to initiate Phase II clinical trial of TST002 in patients with reduced bone mineral density

Unveiled updated efficacy data from Osemitamab (TST001) plus CAPOX as first-line treatment for G/GEJ cancer study at ESMO 2023

Preclinical results of [177Lu]Lu-TST001 radionuclide antibody conjugate as potential novel treatment option for metastatic gastric cancer have been published on European Journal of Nuclear Medicine and Molecular Imaging

Sustainability

Operation in Sincere & Compliance Faith
Adherence to compliance operation is a prerequisite for sustainable and healthy corporate development. The Company adheres to business ethics standards and regards integrity and compliance as the basic guarantee for high-quality corporate development, continuously improves its internal and external risk prevention mechanism and governance structure, and integrates ESG concepts into its management to enhance the Company’s risk prevention and control capability and resilience on an on-going basis.

Science-Rooted Success
The Company is committed to fulfilling the brand connotation of “Innovate to excel” with practical actions through science-rooted and innovation-sourced principles. In the process of continuously exploring innovative research and development, we strictly comply with the Drug Administration Law of the People’s Republic of China (《中華人民共和國藥品管理法》), the Regulation for the Administration of Human Genetic Resources of the People’s Republic of China (《中華人民共和國人類遺傳資源管理條例》) and other regulatory requirements on drug research and development to safeguard innovative research and development; the Company also continuously pursues high-quality products, improves the quality management system covering the whole life cycle, and embraces global cooperation with an open attitude to further stimulate innovation vitality, striving to develop and provide better and more affordable innovative treatments for patients.

Building Clean & Harmonious Ecosystems
Green and low-carbon development has become the theme of the current economic and social development. The Company implements the concept of green development, identifies and controls the possible impacts of the Company’s operation, products and services on the environment. It also actively explores green and innovative technologies to improve resources utilization, reduce pollution emissions and achieve the coordinated development of its own economic benefits and environmental benefits.

Enjoying Beautiful and Happy Life
Talents are key guarantees to the continuous business growth of enterprises. The Company attaches great importance to the recruitment and development of employees, respects and protects the basic interests of each employee and strives to create a positive and friendly working atmosphere with mutual assistance for employees to bring a broader space for staff growth and constantly enhance the sense of happiness and fulfillment of employees. Meanwhile, the Company actively fulfills the social responsibilities of corporate citizens and encourages employees to participate in social and public welfare activities to create beautiful communities and enjoy happy life together.

钱雪明 博士

首席执行官

钱雪明博士拥有 20 年商业化抗体发现和开发的经验。曾任北京盛诺基医药科技的高级副总裁兼研发主管、安进首席科学家,领导多个项目团队,发现新型的自身免疫性和代谢疾病(骨骼和肾脏)治疗用抗体药物。他是多项抗体专利的主要发明者。毕业于复旦大学生物物理学系,并分别在哥伦比亚大学和奥尔巴尼医学中心获得神经学与生理学硕士学位和神经学与药理学博士学位。