Initiation of KJ103 Phase III Clinical Trial China's Innovative Drug Opens a New Era for Anti-GBM Disease Treatment

On 28 December 2025, Bao Pharmaceutical convened in Beijing the “National Investigator Phase III Protocol Discussion and Phase III Clinical Trial Initiation Meeting for KJ103 in Anti–Glomerular Basement Membrane (GBM) Disease.” This miles***e marks the entry of China’s first targeted, breakthrough therapy for this disease into a critical stage of clinical development. The Phase III trial is led by Peking University First Hospital, with Professor Zhao Minghui as the principal investigator, alongside more than 20 leading nephrology experts nationwide. The hybrid online–offline format underscored China’s transition in pharmaceutical innovation from “following” to “leading.”

A Breakthrough Therapy: Phase II Data Reshapes the Treatment Landscape
In his opening remarks, Professor Zhao noted that anti-GBM disease is an acute, rapidly progressive autoimmune disorder with a poor prognosis and limited efficacy from conventional treatments. As the world’s first low-pre-existing-antibody IgG-degrading enzyme to advance to Phase III, KJ103 demonstrated a transformative benefit in Phase II studies: 75% of treated patients achieved dialysis independence within six months—substantially outperforming existing therapies.
“KJ103’s Phase II results not only fill a major treatment gap but redefine the standard of care for anti-GBM disease,” Professor Zhao emphasized. “The Phase III launch is a pivotal step toward international leadership, and we look forward to rigorous validation to deliver better solutions for patients.”

Patient-Centric Innovation
Bao Pharma’s Chairman, Dr. Liu Yanjun, outlined the company’s R&D philosophy: “From Phase II outcomes to Phase III design, we have consistently anchored our work in clinical needs. The efficacy and safety demonstrated by KJ103 embody our commitment to act urgently for patients.” He added that, despite uncertainties inherent in innovation, deep engagement with clinical experts and a differentiated R&D strategy are enabling China-originated drugs to move from ‘catch-up’ to setting global standards.

A Phase III Protocol Informed by Collective Expertise
During the meeting, experts systematically reviewed Phase II data and engaged in in-depth discussions on Phase III trial design, endpoint asses**ent, safety monitoring, and inclusion/exclusion criteria, offering constructive recommendations that laid a solid foundation for **ooth trial execution.
“Every detail refined serves a single goal—meeting international standards and delivering better, more effective therapies for anti-GBM disease,” Professor Zhao concluded.

From a China Solution to Global Guidelines: The Rise of an Innovation Ecosystem
Beyond initiating a trial, the meeting highlighted China’s growing capacity to lead in medical innovation. Bao Pharma’s clinically driven R&D model is propelling China-originated medicines from laboratory breakthroughs to participation in global guideline setting. As Dr. Liu stated, “We look forward to working hand-in-hand with clinical experts to make KJ103 a miles***e therapy that rewrites the history of anti-GBM disease treatment.”

Forward-Looking Statement

This press release may contain forward-looking statements based on current expectations, assumptions, and projections made by the management of Shanghai Bao Pharmaceutical Co., Ltd. (“Bao Pharma”). These statements involve known and unknown risks, uncertainties, and other factors that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such statements include, but are not limited to, descriptions of business strategies, future operational plans, R&D progress, clinical-trial outcomes, commercial prospects, and financial performance. Except as required by law or regulation, Bao Pharma undertakes no obligation to update or revise any forward-looking statement to reflect new information, future events, or other changes. This press release is for informational purposes only and does not constitute investment advice or an offer to purchase securities of the company.