BEIJING,Aug. 27,2024 --Shanghai Ark Biopharmaceutical Co.,Ltd. ("ArkBio"),a privately held,clinical-stage biopharmaceutical company today announced that Dr. Jim Wu,Chief Executive Officer of ArkBio,gave an oral presentation entitled"Development of Next Generation Broadly Active IPF Drug AK3280"at the 8th Annual IPF Summit held in Boston on August 22,2024. AK3280 is a next-generation broad-spectrum anti-fibrotic drug for the treatment of idiopathic pulmonary fibrosis (IPF) and is undergoing a randomized,double-blind,multicenter phase 2 PoC clinical study. The clinical trial led by Professor Huaping Dai of the China-Japan Friendship Hospital,Beijing,is being conducted across 31 hospitals in China to evaluate the safety,tolerability,and efficacy of AK3280 in IPF patients.

Dr. Wu stated："Although there are already two IPF drugs on the market,both suffer from poor tolerability and lower efficacy that do not improve patient's symptoms. Successful completion of patient enrollment for Phase 2 study is an important milestone for AK3280 as a next generation broadly active IPF drug. We extend our sincere gratitude to all the patients and investigators who participated in the trial for their efforts and contribution. The safety and efficacy results from this study will provide key scientific evidence for the continuous clinical development of the drug. We will work closely with investigators to advance clinical development of AK3280 and address the unmet medical need in treatment of IPF. ArkBio commits to the pursuit of innovative drugs for the treatment of respiratory and pulmonary diseases."

About the 8th Annual IPF Summit

The IPF Summit is the largest IPF drug development forum for the pulmonary fibrosis research community. Its annual conference brings together pharmaceutical and biotech companies,clinicians,and academic researchers from around the globe with the goal to harness emerging biological understanding,apply novel and evolving models,and assess patient populations to propel innovative and efficacious pulmonary fibrosis therapeutics through phase 2 and beyond. For more information about the Annual IPF Summit conference,please visit ipf-summit.com.

About Idiopathic Pulmonary Fibrosis

Idiopathic Pulmonary Fibrosis (IPF) is a chronic,progressive form of fibrosing interstitial pneumonia of unknown cause. IPF predominantly affects the elderly,with a median onset age of 65 years. The primary symptoms include progressively worsening shortness of breath,accompanied by restrictive ventilatory impairment and gas exchange abnormalities,leading to hypoxemia and even respiratory failure. The disease is confined to the lungs with pathological and/or radiological features consistent with usual interstitial pneumonia (UIP).

IPF has an insidious onset,followed by continuous,unpredictable,and irreversible progression. Its prognosis is worse than that of most lung cancers. The five-year survival rate is only 20% with a median survival time of just 2-3 years from diagnosis,which is why it is often considered a cancer-like disease. Smoking,respiratory viral infections,and environmental factors are potential risk factors for IPF.

About AK3280

AK3280 is a next-generation broad-spectrum anti-fibrotic molecule optimized from the marketed drug pirfenidone. It has the ability to modulate multiple pathways and biomarkers closely associated with the fibrotic process,including the expression of fibrosis-related genes and proteins induced by transforming growth factor-beta (TGF-β) and lysophosphatidic acid (LPA). AK3280 works by reducing cell proliferation and inhibiting the synthesis and accumulation of extracellular matrix. Compared to pirfenidone,AK3280 offers advantages in safety and tolerability,with potentially much better clinical efficacy. It is currently undergoing a phase 2 proof-of-concept clinical trial in patients with IPF in China.

About ArkBio

ArkBio is a global biotech company focusing on discovery and development of innovative drugs for unmet medical needs,especially in the areas of pediatric and respiratory/lung diseases. Since its inception in 2014,the company has established core technology platforms and built an innovative and highly differentiated R&D pipeline through in-house R&D efforts and external collaborations. One of the core drug products,ziresovir,is thefirst direct-acting RSV antiviral drug that successfully completed phase III clinical trial with positive results. Moreover,ziresovir is the first non-oncology drug that has received a breakthrough designation from NMPA.Another near-commercial drug asset is an attention deficit hyperactivity disorder (ADHD) drug AZSTARYS®that has been approved by FDA. ArkBio owns the right for its development and commercialization inGreater China. The R&D pipeline program also includes a battery of clinical and pre-clinical stage drug candidates with first- or best-in-class potential for global clinical development.

ArkBio has established strategic partnerships with several multinational pharmaceutical companies and academic institutes,including Roche,Genentech,the Scripps Research Institute,the Institute of Microbiology of Chinese Academy of Sciences,domestic and global biotechnology companies,as well as venture investment institutions.

For more information about the company,please visit our website www.arkbiosciences.com

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