# Alebund Pharmaceuticals Announces 2026 Interim Results

- Link: https://www.thailand-business-news.com/pr-news/alebund-pharmaceuticals-announces-2026-interim-results
- Published: 2026-08-26T17:59:00+07:00
- Author: PR Newswire

SHANGHAI, Aug. 26, 2026 /PRNewswire/ — Alebund Pharmaceuticals (Jiangsu) Limited("
Alebund" or the "Company"; stock code: 09637.HK), a renal-focused biopharmaceutical
company, today announced its unaudited consolidated interim results for the six 
months ended June 30, 2026 (the "Reporting Period"). During the Reporting Period
and up to the date of the interim results announcement, the Company made significant
progress on four fronts: clinical development, external collaborations, commercialization
in China, and the capital markets.

**Highlights of the Reporting Period**

**Clinical Development**

 ◦ **AP301 — patient enrollment completed in the global Phase III pivotal multi-
   regional clinical trial; the New Drug Application in China accepted for review
   by the National Medical Products Administration of China (the "NMPA").** In May
   2026, RESPOND-2, the global Phase III pivotal multi-regional clinical trial (
   the "MRCT") conducted in the United States and China, completed patient enrollment.
   On August 7, 2026, subsequent to the Reporting Period, the New Drug Application
   submitted by the Company for AP301 for the treatment of hyperphosphatemia in 
   chronic kidney disease ("CKD") patients receiving maintenance dialysis was accepted
   for review by the NMPA as a Class 1 chemical drug in China.
 ◦ **AP306 — the global Phase IIb multi-regional clinical trial has been initiated.**
   The trial is co-sponsored by the Company and R1 Therapeutics, Inc. ("R1"), with
   the Company leading the conduct of the trial in the Chinese Mainland. The trial
   plans to enroll a total of approximately 168 participants with hyperphosphatemia
   receiving maintenance hemodialysis, and the first participant was randomized 
   and dosed in July 2026, subsequent to the Reporting Period, as announced by the
   Company. The trial is expected to be completed in the second quarter of 2027,
   and the Company will announce topline results in due course.
 ◦ **AP303** — the data from three completed Phase I/Ib clinical trials have been
   published in _Kidney International Reports_ in August 2026, demonstrating that
   AP303 was safe and well tolerated; the expected dose-related hemodynamic effects
   were observed in healthy participants and patients with diabetic kidney disease(
   DKD).
 ◦ **AP308** — preclinical results published in May 2026 in _Kidney International_.
   In humanized IgA (immunoglobulin A) nephropathy mouse models, AP308 reduced circulating
   human IgA1 by approximately 90% after a single dose, and eight weeks of treatment
   achieved near-complete clearance of glomerular IgA deposits with significant 
   improvement in renal pathology and no treatment-related adverse effects; in a
   separate paired design, a single dose completely cleared established glomerular
   IgA and complement C3 deposits.

**External Collaborations**

 ◦ **Licensing and equity agreements in respect of AP306 entered into with R1 Therapeutics.**
   In March 2026, the Company announced that it had entered into licensing and equity
   agreements in respect of its product candidate AP306 with R1. The Company retains
   all rights to AP306 in Greater China and holds an equity interest in R1 as a 
   principal shareholder, while R1 has obtained an exclusive license to develop,
   manufacture, and commercialize AP306 outside Greater China. R1’s shareholders
   include DaVita (NYSE: DVA) and U.S. Renal Care, leading global kidney care providers.
   During the Reporting Period, the Company recognized licensing revenue of RMB79.3
   million from the transaction.

**Commercialization in China**

 ◦ **Sales revenue of Mircera® increased by approximately 105.0% year-on-year.**
   During the Reporting Period, Mircera® generated sales revenue of RMB24.8 million(
   corresponding period of 2025: RMB12.1 million), representing a year-on-year increase
   of approximately 105.0%.

**Capital Markets**

 ◦ **Listing of the H Shares on the Main Board of the Stock Exchange.** The H Shares
   of the Company were listed on the Main Board of The Stock Exchange of Hong Kong
   Limited (the "Stock Exchange") on June 29, 2026 (stock code: 09637). Together
   with the full exercise of the Over-allotment Option under the Global Offering
   on July 24, 2026, subsequent to the Reporting Period, the aggregate net proceeds
   from the Global Offering amounted to approximately HK$1,355.8 million, of which
   approximately HK$184.7 million in additional net proceeds was attributable to
   the exercise of the Over-allotment Option.

**Financial Overview**

 ◦ **Revenue growth with narrowing losses.** Revenue for the first half of 2026 
   grew to RMB104.2 million from RMB12.1 million for the first half of 2025, representing
   an increase of RMB92.1 million, or 761.2%, primarily reflecting licensing revenue
   of RMB79.3 million recognized under the licensing and equity agreements entered
   into with R1 in respect of AP306, as well as sales revenue of RMB24.8 million
   from the commercialized product Mircera®; loss for the period was RMB162.6 million,
   narrowing by 22.5% year-on-year, and adjusted net loss for the period (non-International
   Financial Reporting Standards ("IFRS") measure) was RMB130.1 million, narrowing
   by 12.6% year-on-year. As of June 30, 2026, the aggregate balance of cash and
   cash equivalents, time deposits, and wealth management products was RMB1,392.8
   million, representing an increase of RMB861.6 million.

**Financial Summary**

  |

**RMB’000 (UNAUDITED)**

  |

**SIX MONTHS **

**ENDED JUNE 30, 2026**

  |

**SIX MONTHS **

**ENDED JUNE 30, 2025**

  |  
 |

REVENUE

  |

104,159

  |

12,112

  |  
 |

GROSS PROFIT

  |

91,089

  |

5,262

  |  
 |

RESEARCH AND DEVELOPMENT EXPENSES

  |

141,404

  |

110,061

  |  
 |

LOSS FOR THE PERIOD

  |

162,550

  |

209,662

  |  
 |

ADJUSTED NET LOSS FOR THE PERIOD (NON-IFRS MEASURE)*

  |

130,098

  |

148,851

  |  
 |   |  
 |

* Adjusted net loss for the period (non-IFRS measure) represents loss for the period after adding back (i) interest on redemption liabilities on ordinary shares; (ii) share-based payment; and (iii) listing expenses. 

  |

**Product sales.** During the Reporting Period, Mircera®, the Company’s commercialized
product, generated sales revenue of RMB24.8 million, representing an increase of
approximately 105.0% from RMB12.1 million in the corresponding period of 2025; the
gross profit of Mircera® was RMB11.7 million, representing an increase of RMB6.4
million, or 120.8%, from RMB5.3 million in the corresponding period of 2025, and
the gross profit margin improved from 43.4% for the first half of 2025 to 47.3% 
for the first half of 2026.

**Licensing value.** In March 2026, the Company completed its performance obligations
under the licensing and equity agreements entered into with R1 in respect of AP306
and recognized licensing revenue of RMB79.3 million; the consideration was received
in the form of unlisted class B common shares of R1 as upfront, non-monetary, and
non-refundable consideration. Together with the sales revenue of Mircera®, revenue
for the first half of 2026 grew to RMB104.2 million from RMB12.1 million for the
first half of 2025, representing an increase of RMB92.1 million, or 761.2%.

**Narrowing of losses.** Net loss for the first half of 2026 narrowed by RMB47.1
million, or 22.5%, to RMB162.6 million from RMB209.7 million for the first half 
of 2025. The narrowing was primarily driven by (i) the increase in licensing revenue
during the Reporting Period and (ii) the termination, prior to the Listing, of the
redemption liabilities in respect of certain shares of the Company (which is one-
off in nature), following which no related interest was accrued during the Reporting
Period. Adjusted net loss for the first half of 2026 was RMB130.1 million, a decrease
of RMB18.8 million, or 12.6%, from RMB148.9 million for the first half of 2025, 
likewise primarily due to the increase in licensing revenue during the period.

**R&D investment.** Research and development (R&D) expenses increased by RMB31.3
million, or 28.4%, to RMB141.4 million for the first half of 2026 from RMB110.1 
million for the first half of 2025. The increase primarily reflected progress across
the R&D pipeline during the Reporting Period, including the completion of patient
enrollment in the AP301 MRCT, the initiation of the global Phase IIb multi-regional
clinical trial of AP306, and the continued advancement of preclinical and chemistry,
manufacturing, and controls (CMC) studies of AP308.

**Liquidity.** As of June 30, 2026, the aggregate balance of cash and cash equivalents,
time deposits, and wealth management products was RMB1,392.8 million, representing
an increase of RMB861.6 million, or 162.2%, from December 31, 2025.

**Business Progress**

**AP301: A Best-in-Class Oral Iron-Based Phosphate Binder for the Treatment of Hyperphosphatemia**

AP301 is a best-in-class oral iron-based phosphate binder (registered as a Class
1 chemical drug in China), offering a very high phosphate-binding capacity, no need
for chewing, minimal volume expansion in gastric fluid, and no systemic absorption.
These characteristics help reduce the amount of medication patients need to take
each day and lower the incidence of gastrointestinal adverse events such as nausea,
vomiting, constipation, and intestinal obstruction, thereby delivering better safety
and gastrointestinal tolerability and enhancing patients’ long-term treatment adherence.

**Global Phase III pivotal multi-regional clinical trial (RESPOND-2, NCT06933472)
underway.** The trial is a randomized, double-blind, global multi-regional Phase
III clinical trial conducted in the United States and China. It planned to enroll
264 CKD patients aged 12 years and above with hyperphosphatemia receiving maintenance
dialysis, and ultimately enrolled a total of 282 patients (138 in the United States
and 144 in China). Based on the existing clinical data for AP301, the Company and
the FDA have agreed that this global Phase III multi-regional clinical trial will
serve as the single pivotal study to support the U.S. registration of AP301. The
trial completed patient enrollment in May 2026.

**Registration progress, catalysts and future milestones.** On August 7, 2026, subsequent
to the Reporting Period, the New Drug Application submitted by the Company for AP301
for the treatment of hyperphosphatemia in CKD patients receiving maintenance dialysis
was accepted for review by the NMPA as a Class 1 chemical drug in China. The application
is supported primarily by the results of RESPOND-1, the China pivotal Phase III 
clinical trial, together with other accumulated clinical data; the Company will 
actively cooperate with the NMPA’s review and expects to obtain approval in 2027,
subject to the progress of the regulatory review. The global Phase III multi-regional
clinical trial is expected to be completed in the second quarter of 2027, following
which the Company plans to submit a New Drug Application to the FDA.

**AP306: First-in-Class Oral Pan-Phosphate Transporter Inhibitor with the Potential
to Reshape the Treatment Landscape of Hyperphosphatemia**

AP306 (formerly known as EOS789, originally discovered by Chugai) is an oral pan-
phosphate transporter inhibitor that simultaneously inhibits three key sodium-dependent
intestinal phosphate transporters: phosphate transporter type IIb (NaPi-IIb), phosphate
transporter-1 (PiT-1), and phosphate transporter-2 (PiT-2). As of the Latest Practicable
Date (August 20, 2026), AP306 is the world’s first and only pan-phosphate transporter
inhibitor to have entered clinical development — the only oral agent that simultaneously
targets these three key intestinal phosphate transporters.

**The global Phase IIb multi-regional clinical trial underway.** The trial (NCT06712654)
is a multicenter, randomized, double-blind, placebo-controlled, fixed-dose study
conducted at multiple clinical sites in the United States and China and co-sponsored
by the Company and R1, designed to evaluate the safety, tolerability, and serum 
phosphate-lowering effect of AP306. The trial plans to enroll approximately 168 
participants with hyperphosphatemia receiving maintenance hemodialysis, randomized
across six fixed-dose AP306 regimens and placebo over an eight-week treatment period.
The primary endpoint is the change in serum phosphate level from baseline to the
end of treatment, and the secondary endpoints include the proportion of participants
reaching the target phosphate range and the time to phosphate control. The trial
has been approved by the Office of Human Genetic Resources Administration of China.
As announced by the Company on July 21, 2026, subsequent to the Reporting Period,
the first participant in the trial was randomized and dosed.

**Catalysts and future milestones.** The global Phase IIb multi-regional clinical
trial described above is expected to be completed in the second quarter of 2027,
and the Company will announce topline results in due course. The Company also plans
to initiate a global Phase III multi-regional clinical trial in the second half 
of 2027.

**Regulatory designation.** In June 2024, AP306 was granted Breakthrough Therapy
Designation by the NMPA for the treatment of hyperphosphatemia in patients with 
chronic kidney disease.

**AP303: A First-in-Class Oral Dual PPAR Agonist Intended to Delay or Halt the Progression
of Chronic Kidney Disease**

AP303 is a first-in-class oral small-molecule dual peroxisome proliferator-activated
receptor (PPAR) α/γ agonist discovered and developed in-house, and the Company holds
the global rights to develop, manufacture, and commercialize it. A differentiated
disease-modifying agent, AP303 is intended to delay or halt the progression of chronic
kidney disease, with target indications spanning multiple high-value therapeutic
areas, including DKD, IgA nephropathy (IgAN), autosomal dominant polycystic kidney
disease (ADPKD), and focal segmental glomerulosclerosis (FSGS).

**Clinical development progress.** AP303 has completed three Phase I clinical trials,
which enrolled a total of 80 healthy participants and 18 DKD patients with impaired
renal function and showed that AP303 was safe and well tolerated. The expected dose-
related hemodynamic effects were observed in both healthy participants and patients
with DKD. These Phase I results support the initiation of Phase II studies in patient
populations. The Phase I/Ib clinical data were published in _Kidney International
Reports_ in August 2026.^([1])

**Regulatory progress: Phase II clinical trial approvals obtained.** In China, the
Company submitted an Investigational New Drug application for the Phase II clinical
trial to the NMPA and obtained approval for the pan-CKD indication, which can cover
subsequent Phase II clinical trials in patients with DKD, IgAN, ADPKD, and FSGS.
In the United States, the Company has communicated with the FDA regarding DKD, IgAN,
ADPKD, and FSGS and received positive feedback. Among these, the ADPKD indication
has been granted Orphan Drug Designation (ODD), and Phase II clinical trial approvals
have been obtained for the DKD and IgAN indications.

**Subsequent development plan.** The Company expects to begin site selection for
the Phase II basket trial in DKD and IgAN in the second half of 2026, while preparing
in parallel for the initiation of the Phase II multi-regional clinical trials in
ADPKD and FSGS and maintaining ongoing communication with the relevant regulatory
authorities.

**AP308: A First-in-Class Engineered Recombinant IgA Protease Aiming for Functional
Cure of IgA Nephropathy**

AP308 is an engineered recombinant IgA protease derived from _Thomasclavelia ramosa_,
a human commensal bacterium, and specifically cleaves human IgA1 at a site upstream
of the hinge region. Unlike existing therapies that reduce upstream IgA production
by modulating B-cell pathways (such as APRIL/BAFF), AP308 acts by directly cleaving
and clearing pathogenic IgA and IgA immune complexes that have already formed, including
IgA deposited in the glomeruli.

**Preclinical data.** In the humanized mouse model of IgA nephropathy, a single 
dose reduced circulating human IgA1 by approximately 90% relative to controls, and
circulating IgA1 remained low throughout the eight-week treatment period of weekly
subcutaneous dosing; at the end of treatment, histological examination confirmed
that glomerular IgA deposits were almost completely cleared, proteinuria decreased
significantly, and kidney pathology improved markedly, while repeated dosing produced
no treatment-related adverse reactions and no increase in anti-drug antibody titers.
In a separate paired pre- and post-treatment design, a single dose completely cleared
pre-existing glomerular IgA and complement C3 deposits. As of the Latest Practicable
Date, no IgA protease drug candidate globally has entered the clinical stage. These
results were published in May 2026 in _Kidney International_, the official journal
of the International Society of Nephrology (ISN).^([2])

**Development stage, catalysts and future milestones.** As of the Latest Practicable
Date, AP308 is at the preclinical stage. The Company plans to submit Investigational
New Drug applications for AP308 to the NMPA and the FDA, respectively, in the second
half of 2026, and will initiate the Phase I clinical trial of AP308 upon obtaining
the relevant clearances.

**External Collaboration**

In March 2026, the Company announced that it had entered into licensing and equity
agreements in respect of its product candidate AP306 with R1; the agreements were
entered into in December 2025. The Company retains full rights and control over 
AP306 in Chinese Mainland, Hong Kong, Macau and Taiwan (collectively, "Greater China"),
while R1 has obtained an exclusive license to develop, manufacture, and commercialize
AP306 outside Greater China (the "R1 Territory"). R1 and the Company are co-sponsors
of the global Phase IIb clinical trial; each party is responsible for clinical trial
execution and regulatory submissions in its respective territory and provides the
other party with relevant data and support required for regulatory purposes. During
the Reporting Period, the Company recognized licensing revenue of RMB79.3 million
from the transaction.

**Commercialization in China: Mircera®**

Mircera® (generic name: methoxy polyethylene glycol-epoetin beta) is a long-acting
erythropoiesis-stimulating agent (ESA) of the continuous erythropoietin receptor
activator (CERA) class and the world’s first and only ESA approved for once-monthly
administration. As of the Latest Practicable Date, no biosimilar of Mircera® has
been approved or is under review anywhere in the world. In October 2023, the Company
entered into a supply and marketing agreement with Roche Hong Kong, Ltd. ("Roche",
a subsidiary of Roche Holding AG), obtaining the exclusive rights to sell, distribute,
and otherwise commercialize Mircera® in the Chinese Mainland (excluding Hong Kong,
Macau, and Taiwan); Roche is responsible for supply and for maintaining the drug
registration certificate, while the Company is responsible for obtaining the permits
required for promotion. Mircera® was included in the National Reimbursement Drug
List (Category B) through the national medical insurance negotiations in 2023 and
its listing was renewed in 2025 with no price reduction.

In the first half of 2026, revenue of Mircera® reached RMB24.8 million, an increase
of approximately 105.0% from RMB12.1 million in the corresponding period of 2025,
at a gross profit margin of approximately 47.3%. The Company has built a dedicated
in-house nephrology sales team comprising 43 sales personnel as of the Latest Practicable
Date to conduct academic promotion. The commercial availability of Mircera® has 
given the Company proven access channels to public hospitals, an established distribution
network, and dedicated nephrology academic promotion capabilities ahead of the approval
of AP301 — ready-made infrastructure for the commercialization of AP301 and subsequent
products.

**Integrated R&D, Manufacturing, and Commercialization Capabilities**

**Manufacturing capabilities.** Construction of the Company’s in-house manufacturing
facility in Yangzhou is complete, and the facility has obtained a Drug Manufacturing
License (Category B) issued by the Jiangsu Provincial Drug Administration. It has
completed pilot-scale production and is preparing for scale-up, to support future
commercial-scale production of product candidates such as AP301 and AP306.

**Intellectual property.** As of the Latest Practicable Date, the Company held 39
granted patents and 117 pending patent applications worldwide, spanning major jurisdictions
including China, the United States, and Europe, and together covering the key inventions
that underpin the Company’s product pipeline. During the Reporting Period, the Company
was granted 7 new patents and filed 22 new patent applications.

**Outlook**

The Company is committed to bringing better treatment options, covering the full
course of disease, to patients with chronic kidney disease and related diseases 
worldwide.

In the treatment of complications in patients with end-stage renal disease, the 
New Drug Application for the Company’s core product AP301 in China was accepted 
for review by the NMPA on August 7, 2026, subsequent to the Reporting Period. We
will give the review process our full cooperation and, following completion of the
global Phase III multi-regional clinical trial in the second quarter of 2027, will
submit a New Drug Application to the FDA. In parallel, we will press ahead with 
capacity preparation at the Yangzhou manufacturing facility and continue building
out our nephrology commercialization system, so that AP301 can benefit patients 
as soon as possible. For AP306, we will work with R1 to advance enrollment and execution
of the global Phase IIb multi-regional clinical trial and will disclose topline 
results in due course.

In delaying the progression of CKD, we have now obtained all Phase II clinical trial
approvals for AP303. In the second half of 2026, we will begin site selection for
the Phase II basket trial in DKD and IgAN, prepare in parallel for initiation of
the Phase II multi-regional clinical trials in ADPKD and FSGS, and map out the later-
stage registration pathway for IgAN. For AP308, we will advance the submission of
its Investigational New Drug applications and, once the relevant clearances are 
obtained, initiate the Phase I clinical trial. We will disclose these developments
in due course.

In addition, we will continue to strengthen our integrated capabilities across R&
D, manufacturing, and commercialization, advance capacity preparation at the Yangzhou
manufacturing facility as planned, and continue to expand our product pipeline in
kidney disease through a two-pronged approach of internal R&D and external collaboration.

**References**

[1] Perkovic V, et al. _Randomized clinical trials of deutaleglitazar in healthy
participants and in patients with diabetic kidney disease._ Kidney Int Rep. Published
online August 20, 2026. doi:10.1016/j.ekir.2026.107037

[2] Shen X, et al. _Therapeutic efficacy and antigenicity of a novel PEGylated IgA
protease in preclinical models of IgA nephropathy._ Kidney Int. 2026;110:463–476.
doi:10.1016/j.kint.2026.04.020

**About Alebund Pharmaceuticals**

Alebund Pharmaceuticals (09637.HK) is a biopharmaceutical company focused on kidney
disease and related chronic conditions, aiming to bring better therapies to patients
worldwide. It has one of the broadest renal-focused pipelines and an integrated 
platform spanning R&D, manufacturing and commercialization. Its portfolio comprises
seven investigational drug candidates and one commercialized product, Mircera®. 
Three of the candidates are at the clinical stage: AP301 (Phase III; China pivotal
Phase III trial completed, New Drug Application accepted for review by the NMPA 
in China, global MRCT ongoing), AP306 (Phase II) and AP303 (Phase I). Together they
address chronic kidney disease (CKD) and its complications, including hyperphosphatemia,
renal anemia, IgA nephropathy, diabetic kidney disease, FSGS and ADPKD. Alebund 
has built a manufacturing site in Yangzhou, Jiangsu to support the future commercial
manufacturing of AP301 and other pipeline products, has obtained a Drug Manufacturing
License (Category B) issued by the Jiangsu Provincial Drug Administration, and has
completed pilot-scale production and is preparing for scale-up. The Company has 
also established a dedicated nephrology sales team responsible for the commercialization
of relevant products in China. For more information, visit [www.alebund.com](https://www.alebund.com/).

**Forward-Looking Statements**

This press release contains certain forward-looking statements relating to the Company’s
future plans, clinical development and registration progress, commercialization 
prospects and industry trends, among other matters. These statements are based on
the Company’s judgments and assumptions as of the date of this press release and
are subject to various risks and uncertainties; actual results may differ materially
from such forward-looking statements. For further details of the Company’s 2026 
interim results, please refer to the interim results announcement published on the
websites of the Stock Exchange ([www.hkexnews.hk](http://www.hkexnews.hk)) and the
Company ([www.alebund.com](http://www.alebund.com)), and the interim report of the
Company to be made available in due course.

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