About Laekna

Stock Code: 2105.HK

Founded in 2016, Laekna is a science-driven, clinical-stage biotechnology company committed to bringing novel therapeutics to patients with metabolic diseases,cancer and liver fibrosis around the world.

As of December 31, 2024, Laekna has initiated seven clinical trials for LAE102, LAE002(afuresertib), LAE001 and LAE005 to address unmet medical needs in obesity and cancers.

LAE102 is our internally discovered antibody against ActRIIA. Blocking Activin-ActRII pathway could promote muscle regeneration and decrease fat mass, this positions LAE102 as a promising drug candidate for achieving quality weight control. We’ve obtained IND approvals from the FDA and the CDE for LAE102 in obesity indication and are advancing the Phase I clinical trial in China. In November 2024, Laekna entered into a clinical collaboration agreement with Eli Lilly and Company to support and accelerate global clinical development of LAE102 for the treatment of obesity.

Laekna team has accumulated tremendous experiences and deep know-how in the specific field of targeting ActRII receptors and is developing more drug candidates (LAE103 and LAE123), in addition to LAE102, to maximize the value of the target. LAE103 is an ActRIIB-selective antibody and LAE123 is a dual inhibitor against ActRIIA/IIB. Both are our internally discovered antibodies for muscle and other disease indications.

In the cancer area, Laekna has built a comprehensive portfolio of drug candidates including LAE002(afuresertib), LAE001 and other seven pre-clinical drug candidates. LAE002 (afuresertib) is a potent AKT inhibitor that inhibits all three AKT isoforms (AKT1, AKT2 and AKT3) as well as one of the only two AKT inhibitors in late-stage development for breast and prostate cancer globally. Laekna has commenced the Phase III clinical trial (AFFIRM-205) for LAE002 in patients with HR+/HER2- breast cancer and the study recruitment is on track.

Laekna, Inc. (2105.HK) was listed on the Main Board of The Stock Exchange of Hong Kong Limited (the “Hong Kong Stock Exchange”) on June 29, 2023.

For more information, please visit: https://www.laekna.com/ or https://www.linkedin.com/company/74110713/

Our Vision

Let Health

Your Choice

Glossary & abbreviations

MCRPC: metastatic castration-resistant prostate cancer IND: investigational new drug MRCT: multi-regional clinical trial PROC: platinum-resistant ovarian cancer TNBC: triple negative breast cancer ActRIIA: activin receptor type IIA HR+/HER2- breast cancer: the most common type of breast cancer with overexpression of HR and without overexpression of HER2

Board of Directors

Executive Directors

Dr. Chris LU （Chairman）
Dr. Chris LU is the founder, Chairman, Executive Director and CEO of Laekna, Inc. (“Laekna”).

Prior to Laekna, Dr. LU was Executive Director at Novartis AG, where he was responsible for leading the drug discovery platform and multiple disease research programs. He was previously a venture partner at Frontline BioVentures (currently 6 Dimensions Capital), a venture capital firm focusing on investment in healthcare industry.

Dr. LU was one of the first scientists to join the Novartis Institutes for BioMedical Research (“NIBR”). After working at NIBR headquarters in Cambridge, Massachusetts, USA for 4 years, he returned to Shanghai in 2007 to help establish China Novartis Institutes for BioMedical Research (“CNIBR”). He was bestowed Novartis VIVA Award with “Novartis Leading Scientist” honorary title in 2012.

Before joining Novartis, Dr. LU worked at Wyeth Research, a U.S. based pharmaceutical company (currently Pfizer) as the principal scientist and had led multiple drug discovery projects. He had worked in Ontogeny, Inc.(currently Curis), a biotechnology company, in 1998.

Dr. LU received his Bachelor of science degree and Master of science degree in biology department from Nankai University in China. He obtained the Doctor of Philosophy degree from the School of Medicine of the University of North Carolina at Chapel Hill in the United States. Dr. LU was a postdoctoral fellow at Harvard University in the United States.

Ms. Ling XIE
Ms. Xie is Co-founder, Executive Director and Senior Vice President of Laekna, Inc. (“Laekna”), responsible for overseeing global operations, including administration, human resources, finance, legal, IT and compliance. Laekna is a clinical-stage global biotechnology company, dedicated to bringing ground-breaking therapies to cancer and liver fibrosis patients worldwide.

Ms. Xie has rich experience of operations in multinational companies, such as Novartis and Boehringer-Ingelheim. Before joining Laekna, Ms. Xie served as an executive assistant at China Novartis Institutes for BioMedical Research (CNIBR), supporting the head of CNIBR.

Ms. Xie was accredited as national second-level psychological counselor by Ministry of Human Resources and Social Security of the PRC, and she was certified as Myers-Briggs Type Indicator (MBTI) practitioner by Center for Applications of Psychological Type in the United States in 2012.

Ms. Xie received her bachelor’s degree in law from East China University of Political Science and Law in China.

Dr. Justin GU
Dr. Justin GU joined Laekna, Inc. (“Laekna”) in 2020 as Chief Scientific Officer responsible for overseeing Group’s pre-clinical discovery research works. He was appointed as an executive Director in May 2022.

Dr. GU has over 20 years of experience in the biotechnology and pharmaceutical industry. Before joining Laekna, Dr. GU was a venture partner at GP Healthcare Capital Co., Ltd. in 2019.

Dr. GU worked at Novartis for 18 years. From 2001 to 2008, he served as a scientist and a group leader at Genomics Institute of the Novartis Research Foundation (GNF) in San Diego, USA. In 2008, Dr. GU returned to China and joined the newly established China Novartis Institute for Biomedical Research (CNIBR), first served as an investigator and then as the director of the lead discovery department.

Dr. GU received his Bachelor’s degree in biology from Nankai University in China; Master’s degree from the Institute of Botany, The Chinese Academy of Sciences; and the Doctor of Philosophy degree in biochemistry from the Ohio State University in the United States. Before entering the pharma industry, Dr. GU worked at Massachusetts Institute of Technology for three years as a postdoctoral fellow.
Non-executive Directors

Dr. David WANG
Dr. Wang was appointed as a Director in July 2019 and re-designated as a non-executive Director in May 2022.

Dr. Wang has over 20 years of experience in the medical industry. Dr. Wang is a partner and senior managing director of Asia at OrbiMed Advisors LLC, an investment fund with a focus on healthcare industry, where he has worked since August 2011.

Dr. Wang had also served or has been serving at multiple publicly listed companies. Dr. Wang received his Bachelor’s degree in medicine from Beijing Medical University (北京医科大学) (currently known as Peking University Health Science Center (北京大学医学部) in China in July 1986. He received his Doctor of Philosophy degree in developmental biology from California Institute of Technology in the United States in June 1995.

Dr. Wang is a director of Laekna Therapeutics.

Ms. Dongmei JI
Ms. Ji was appointed as a Director in April 2022 and re-designated as a non-executive Director in May 2022.

Ms. Ji has over 15 years of experience in equity investment and nearly 20 years of experience in financial institutions. She joined Haitong-Fortis Private Equity Fund Management Co., Ltd. (海富产业投资基金管理有限公司) as an investment manager in 2004, primarily responsible for project management and investment management and she left the company in 2013. From May 2013 to July 2015, she served as the managing director and member of the investment committee of GP Capital Co., Ltd. (金浦产业投资基金管理有限公司), primarily responsible for project management and investment management. Since August 2015, she has been a president, founding managing partner and chairwoman of the investment committee of GP Healthcare Capital Co., Ltd. (上海金浦医疗健康股权投资基金管理有限公司), responsible for managing the overall operation of the company and the fund.

Ms. Ji received her Bachelor’s degree in microbiology and Master’s degree in genetics from Fudan University (复旦大学) in China in July 1996 and in July 1999, respectively.

Ms. Yuan SUN
Mr. Sun was appointed as a Director in April 2022 and re-designated as a non-executive Director in May 2022.

Mr. Sun has over 8 years of experience in investment management industry. He is currently investment director of CS Capital Co., Ltd. (国投招商投资管理有限公司).

Mr. Sun received his Bachelor’s degree in computer science and technology from Tsinghua University (清华大学) in China in July 2010. He received his Master’s degree in finance from Washington University in St. Louis in the United States in December 2012. He obtained the Chartered Financial Analyst qualification in November 2017.

Milestones

2025

In Feb, Obtained IND approval of LAE120 (USP1 inhibitor) from FDA
In March, Initiated LAE102 Phase I MAD study for obesity in China

2024

In Q2, Obtained IND approval of LAE102(ActRIIA mAb) for the treatment of obesity from FDA and CDE
In May, First patient enrolled in AFFIRM-205, a phase III clinical study of LAE002 (afuresertib) plus fulvestrant for the treatment of breast cancer
In June, First subject dosed in phase I clinical trial of LAE102 (a monoclonal antibody against ActRIIA) for the treatment of obesity
In Sep, Announced robust phase 1b data of LAE002 (afuresertib) for breast cancer at ESMO
In Oct, Initiated subcutaneous dosing cohort of LAE102 phase I SAD study for obesity in China
In November, Entered into a clinical collaboration agreement with Eli Lilly of LAE102 for obesity in the U.S.
In December, Completed LAE102 Phase I SAD study for obesity in China with positive results

2023

In May, Received IND approval for Phase I/II study of LAE102 from FDA in the United States
In June, Listed on the Main Board of the HKEX
In Sep, Included as a constituent of the Hang Seng Composite Index, and listed in the Stock Connect

2022

In January, we received IND approval for Phase I/II combination therapy of LAE002 with sintilimab, targeting patients with solid tumors with prior PD-1/PD-L1 treatments from NMPA in China
In March, we received IND approval for Phase II LAE002 and LAE001 combination study in patients with mCRPC in South Korea
In April, we completed Series D financing

2021

In February, we completed Phase I LAE002 and LAE001 combination study in patients with mCRPC in the United States, and entered Phase II stage
In March, we completed Series C financing
In May, we declared the first internally discovered pre-clinical candidate, ActRIIA antibody for immunotherapy of cancers and advanced it to IND-enabling studies
In June, we received IND approval for Phase Ib/III study of LAE002 plus fulvestrant in patients with locally advanced or metastatic HR+/HER2- breast cancer from FDA in the United States
In July, we entered into a collaboration agreement with Innovent to develop a combination therapy of LAE002 with sintilimab, targeting patients with solid tumors with prior PD-1/PD-L1 treatments
In August, we received IND approval for Phase Ib/III study of LAE002 plus fulvestrant in patients with locally advanced or metastatic HR+/HER2- breast cancer from NMPA in China
In September, we completed Phase I clinical trial of LAE001 for mCRPC in China, and entered Phase II stage

2020

In February, we completed Series B financing
In February, we acquired global license of LAE005 from Novartis
In August, we received IND approval for pivotal Phase II MRCT study of LAE002 plus paclitaxel versus paclitaxel in patients with PROC from NMPA in China
In December, we received IND approval for Phase I/II clinical trial of LAE002 combined with LAE005 and nab-paclitaxel for TNBC from NMPA in China

2019

In January, we received IND approval for Phase I/II clinical trial of LAE001 for mCRPC from NMPA in China
In May, we received IND approval for Phase I LAE002 and LAE001 combination MRCT study in patients with mCRPC from FDA in the United States
In November, we received IND approval for pivotal Phase II MRCT study of LAE002 plus paclitaxel versus paclitaxel in patients with PROC from FDA in the United States

2018

In January, we completed onshore Series Seed financing
In May, we completed Series A financing
In May, we acquired global licenses of LAE002 and LAE003 from Novartis

2017

In June, we acquired global licenses of LAE001 from Novartis

2016

Laekna establised