On August 20, 2026 Keymed Biosciences (HKEX: 02162) reported its interim results for the six months ended June 30, 2026. Guided by a clear dual-engine driven strategy, the company demonstrated outstanding execution capabilities: In the domestic market, following the successful commercialization and implementation of medical insurance coverage for the core product Kangyueda, the company’s highly qualified in-house marketing team rapidly stepped up its efforts, driving a robust breakthrough in domestic commercialization revenue from "1 to N", and providing the Company with a robust cash flow and a solid performance foundation. In the overseas market, the research and development capabilities of Keymed continued to be recognized by multinational pharmaceutical companies. Overseas out-licensing collaborations in respect of its key pipelines and their steady clinical advancement not only validated the Company’s innovative capabilities, but also generated substantial upfront payments and milestone revenue. The steady increase in domestic sales and the continued advancement of overseas (BD) activities complemented each other, establishing a dual-engine driven growth model with exceptional resilience and explosive growth potential.

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Rapid Growth in Sales Revenue, and Cash Flows Contribution from Business Development

In the first half of 2026, the company achieved total revenue of RMB617 million, mainly boosted by the strong performance of our commercialization product, Kangyueda’s revenue increased by 132% to RMB393 million. Collaboration revenue amounted to RMB224 million for the six months ended June 30, 2026, primarily attributable to the milestone payment received under the exclusive license agreement with AstraZeneca AB, attesting to the robust potential of our pipeline. Profit for the period reached RMB1,220 million. The swing from loss to profit was primarily driven by the successful merger and acquisition of our NewCo by MNC and rapid revenue growth, alongside enhancement in operational efficiency. The Company’s cash reserves (including cash and cash equivalents, time deposits, and financial assets at FVTPL) amounted to approximately RMB3.24 billion, providing a solid financial foundation for its sustainable growth and global innovation.

Dual-wheel Drive Fully Launched, Pipeline Portfolio Gaining Momentum

In 2026, Kangyueda entered the first year of full-scale volume growth under medical insurance coverage. As of June 30, 2026, the Company’s commercialisation team comprised nearly 500 personnel, covering more than 1,600 hospitals and over 260 cities, with market access initiatives progressing rapidly. Kangyueda generated sales revenue of RMB393 million, representing a year-on-year increase of 132%. In July 2026, Kangyueda was officially included in the National Essential Medicines List (2026 Edition), which took effect on September 1, 2026. Pursuant to the relevant administrative requirements for essential medicines, public medical institutions at all levels nationwide are required to procure and give priority to the use of medicines included in the list. Such inclusion is conducive to enabling Kangyueda to overcome its previous limitations in Grade III Class A hospitals, accelerating its penetration into county-level and primary healthcare markets, broadening terminal prescription settings and further enhancing the accessibility of the medicine.

In January and March 2026, the marketing applications for Stapokibart for the treatment of moderate-to-severe AD in adolescents and prurigo nodularis (PN) were accepted by the NMPA. Concurrently, we are advancing a randomized, double-blind, placebo-controlled Phase III clinical study to evaluate the efficacy and safety of Stapokibart in pediatric subjects with moderate-to-severe AD. As of the date of this announcement, patient enrollment is ongoing. In July 2026, we initiated a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study to evaluate the efficacy and safety of Stapokibart injection with background therapy for the treatment of adolescent patients with SAR.

BD Milestone Realization Drives Further Acceleration of Global R&D

CM336 (BCMA x CD3 bispecific antibody): On June 5, 2026, the Group’s NewCo partner, Ouro Medicines, was successfully acquired by Gilead and Lakefront (Euronext & Nasdaq: LKFT, formerly known as Galapagos), and the transaction has been officially completed. The Group has received an upfront payment of US$257 million, and is entitled to receive milestone payments of up to approximately US$70 million. In addition, the exclusive license agreement entered into between the Group and Ouro Medicines in November 2024 remains in effect. The milestone payments of up to US$610 million will be fulfilled by Gilead and Lakefront, and the tiered royalties on net sales ranging from high single digits to mid-double digits will be fulfilled by Gilead. Through this transaction, Lakefront acquired substantially all of the team and operating assets of Ouro Medicines, and will collaborate with Gilead on the subsequent development of CM336/OM336. Lakefront will be responsible for the ongoing and future Phase I/II clinical studies of CM336/OM336, while Gilead will lead the pivotal registrational and late-stage studies. The exclusive global commercialisation rights (excluding the Greater China region) are solely owned by Gilead.
CMG901/AZD0901 (Claudin 18.2 ADC): The CLDN18.2 ADC, in collaboration with AstraZeneca, is leading the global clinical development timeline among the first tier. CMG901/AZD0901 has obtained Fast Track Designation and Orphan Drug Designation from the FDA for second-line or later gastric cancer as well as Breakthrough Therapy Designation from the CDE, with OS demonstrating a statistically significant and highly clinically meaningful benefit (CLDN18.2 expression rate ≥25% for enrolled subjects). The global multi-center Phase III clinical trial for first-line gastric cancer completed its first patient enrollment in early 2026, and the perioperative gastric cancer study is in the Phase II clinical stage. The development is further differentiated by expanding into additional tumor types, including biliary tract cancer and pancreatic cancer.
CM355/PRO-203 (CD20 x CD3 bispecific antibody): Prolium continues to advance an international multi-center Phase I/II clinical study of CM355/PRO-203 for SSc, and completed the dosing of the first patient with systemic sclerosis in June 2026, and will also initiate therapeutic studies for other B-cell-driven severe autoimmune diseases within 2026.
Intensive Pipeline Breakthroughs, Next-generation blockbuster lead a new iteration

CM512 (a TSLP/IL-13 bispecific antibody): Next-generation blockbuster CM512 is poised to succeed Kangyueda and lead a new iteration of autoimmune disease treatment. As the world’s first IgG-like long-acting dual TSLP/IL-13 inhibitor, CM512 has a half-life of up to 70 days, has met all clinical endpoints in the Phase II clinical trial for CRSwNP. CM512 demonstrates a rapid onset of action, capable of rapidly shrinking nasal polyps at week 4 post-dosing while significantly improving nasal congestion and promoting the recovery of olfactory function. The efficacy of a single injection can be maintained for six months. At week 24, its change from baseline in the Nasal Polyp Score (NPS) was significantly superior to that of the control group, while overall inflammation of the sinus cavity was significantly reduced, and its Phase III clinical trial has been rapidly initiated. The Company has also established a presence in indications including moderate-to-severe asthma, moderate-to-severe COPD, moderate-to-severe AD in adults, perennial allergic rhinitis, and chronic spontaneous urticaria.
CM336 (BCMA x CD3 bispecific antibody): In the field of autoimmune diseases, we continued to advance an open-label, multi-center Phase II clinical study to evaluate the efficacy and safety of CM336 injection for the treatment of relapsed or refractory primary light-chain amyloidosis in the first half of 2026, and this study is currently in the patient enrollment phase. In May 2026, CM336, intended for the treatment of relapsed or refractory light-chain amyloidosis in patients previously treated with bortezomib and CD38 monoclonal antibody (mAb), was included in the Breakthrough Therapy Designation list.
In the first half of 2026, we continued to advance a Phase I/II clinical study to evaluate the safety and efficacy of CM336 injection for the treatment of subjects with relapsed or refractory autoimmune cytopenias. As of the date of this announcement, patient enrollment for Phase I of the clinical study has been completed. In July 2026, an open-label Phase Ib study was initiated to evaluate CM336 injection in patients with active Sjögren’s syndrome.

In the field of oncology, the IND application for the Phase III clinical trial of CM336 in combination with CM313 (a CD38 mAb) for second-line or later-line RRMM was accepted by the National Medical Products Administration (the "NMPA") on July 3, 2026. The study is divided into two parts: Part 1 is a non-randomized safety run-in phase, and Part 2 is a randomized controlled registration cohort, which will evaluate multiple dosing regimens compared to SOC. The trial will be initiated upon receipt of the clinical trial approval.

Other Pipeline Programs Progressing Steadily:
CM313: Continued to advance a randomized, double-blind, placebo-controlled Phase II clinical study to evaluate the safety and efficacy of CM313 (SC) injection in subjects with IgA nephropathy. As of the date of this announcement, this study is in the patient enrollment phase.

CM518D1: Continued to advance a multi-center, open-label Phase I/II clinical trial.

To date, the Company has submitted Investigational New Drug (IND) applications for multiple pipeline candidates, including CM529D1 (a DLL3/SEZ6 bispecific ADC) for small cell lung cancer, CM583 (a long-acting CGRP/PACAP bispecific antibody) for migraine, and CM551 (a long-acting TL1A/IL-23 p19 bispecific antibody) for inflammatory bowel disease.

We expect that multiple First-in-Class pipeline candidates will enter the IND and clinical stages, including long-acting bispecific antibodies, bispecific ADCs, siRNA and Protac, to address global unmet medical needs in chronic diseases and oncology.

Sustained Momentum in R&D, Production, and Talent Solidifies the Foundation

We have built 6 fully-integrated platforms to enable our in-depth R&D in the areas of immunology and oncology including: Antibody Discovery Platform, KeyMedSTAR ADC Platform, TCE Bispecific Antibody Platform, VESIR Oligonucleotide Platform, Small Molecule Platform and KeyCND Blood-Brain Barrier-Penetrating Antibody Delivery Platform. Our platforms are integrated seamlessly to support key drug development functionalities, including antibody screening, small molecule lead compound discovery, antibody conjugation, functional evaluation, in vivo preclinical studies and biomarker identification. We have the expertise and capability to independently complete the entire drug development process from drug discovery to preclinical research to clinical development and to NDA/BLA application.

To ensure production and supply of high-quality and affordable antibody drugs, we have always been committed to enhancing our in-house manufacturing capabilities. We have internally developed high-expressing cell lines to ensure high yield and low costs for our antibody drugs manufacturing. As of the date of this announcement, the production base in Chengdu has 3 pilot production lines and 3 commercial production lines, with a total production capacity of 21,800 litres. The stainless steel production lines with an additional production capacity of 24,000 litres have completed installation and commissioning and will soon be put into use. All such designs comply with the cGMP requirements of the NMPA and the FDA.

As of June 30, 2026, we had 1,768 full-time employees in total, including nearly 500 employees engaging in commercialization and nearly 420 employees engaged in drug discovery and clinical operations. We will continue to recruit talent to meet the growing needs of commercial sales of products, research and development, clinical, production and the Company’s operations.

Standing at the brand-new starting point of its tenth anniversary, Keymed will continue to uphold its "patient-centric" original aspiration. Leveraging the robust momentum of its dual-drive strategy, the Company will accelerate the research and development and commercialisation process of its global pipeline, committing to providing more high-quality and accessible innovative therapies for patients worldwide, and creating long-term, sustainable, and exceptional value for Shareholders.

(Press release, Keymed Biosciences, AUG 20, 2026, View Source [SID1234670256])

On August 20, 2026 Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for safusidenib, the company’s investigational, oral, brain-penetrant selective inhibitor of mutant IDH1.

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"People with IDH1-mutant glioma urgently need additional treatment options. We were eager to pursue Fast Track Designation for safusidenib to hopefully reach these patients on an expedited timeline," said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. "We look forward to working with the FDA as we advance our mission to provide an effective therapy to nearly every patient whose life is impacted by this disease."

FDA Fast Track Designation is designed to facilitate the development and expedite the review of drugs intended to treat serious conditions and address unmet medical need. The designation provides for more frequent interactions with the FDA throughout a drug’s development. If relevant criteria are met, the designation may allow for rolling review of a marketing application, permitting completed sections to be submitted for FDA review as they become available, rather than waiting for the entire application to be complete. These benefits have the potential to shorten the time it takes to bring safusidenib to patients.

The designation was granted based on favorable data from the safusidenib clinical program to date. Most recently, Nuvation Bio announced updated data from the Phase 2 J201 study demonstrating durable responses and a favorable risk-benefit profile over long-term follow-up. Specifically, at a median follow-up of 38.8 months in the J201 study, treatment with safusidenib showed a confirmed objective response rate (cORR) of 51.9%, with median progression-free survival (PFS) not yet reached and a 36-month PFS rate of 79.1%, and only one patient who had previously responded experienced subsequent disease progression. No new safety signals have been identified with longer-term follow-up. These results build upon findings previously published in Neuro-Oncology.

About IDH1-mutant Glioma
Gliomas are the most common type of brain cancer in adults worldwide. In the U.S., nearly 2,500 people are diagnosed with IDH-mutant gliomas each year, of which more than 95% harbor a mutation in the IDH1 gene. Most patients are diagnosed in their 30s and 40s. While patients with IDH1 mutations generally have longer survival times than those with wild-type IDH1, gliomas are not currently curable and prognosis worsens for those with high-risk features, including high grade tumors.

About Safusidenib
Safusidenib is an investigational, oral, brain-penetrant, selective inhibitor of mutant IDH1. It is being studied in patient populations with significant unmet medical need, including settings where there are limited or no approved targeted treatment options. In Phase 1 and Phase 2 clinical studies, safusidenib demonstrated encouraging clinical activity, including delayed disease progression and durable responses across a range of tumor grades and risk groups, with a favorable risk-benefit profile. These early findings support further investigation of safusidenib in the currently enrolling Phase 3 SIGMA study, as well as in the Phase 3 G307 study outside the U.S. where vorasidenib is not yet approved or accessible and the Phase 2 G209 study in a post-vorasidenib setting.

In August 2026, the FDA granted Fast Track Designation to safusidenib in IDH1-mutant glioma.

About the SIGMA (G203) Study
SIGMA is a pivotal Phase 3 study that will evaluate safusidenib compared to placebo as a maintenance therapy after standard-of-care in IDH1-mutant astrocytoma with high-risk features. The pivotal portion of the study will enroll approximately 300 patients.

A separate, exploratory, non-pivotal cohort will evaluate safusidenib in participants with grade 3 IDH1-mutant oligodendroglioma who have not yet received chemotherapy or radiotherapy. The primary endpoint is objective response rate. This cohort is expected to enroll approximately 40 patients.

(Press release, Nuvation Bio, AUG 20, 2026, View Source [SID1234670257])

On August 20, 2026 IntraGel Therapeutics, developer of next generation long-acting injectables, reported an equity investment agreement and a strategic Option and Research License Agreement (the Option Agreement) with UroGen Pharma Ltd. (Nasdaq: URGN), a biotechnology company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers.

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In a related equity investment agreement, UroGen will invest up to $7 million in the equity securities of IntraGel, which will support the Phase 2 clinical development of TumoCure, IntraGel’s investigational therapy for advanced head and neck cancer. Under the related Option Agreement, UroGen receives an exclusive option to obtain an exclusive, worldwide license to develop and commercialize TumoCure following IntraGel’s completion of a Phase 2 clinical study. In addition, UroGen gains access to IntraGel’s proprietary SRGel platform, a biodegradable sustained-release formulation technology designed for localized drug delivery, through a research license and options to obtain an exclusive, worldwide license to develop and commercialize up to three additional oncology products combining the SRGel platform with compounds to be designated by UroGen.

"UroGen’s leadership in localized oncology therapies and commercial-stage experience make them an ideal collaborator to help advance the SRGel platform and accelerate the development of TumoCure," said Peter Siman, Ph.D., Chief Executive Officer and Co-Founder, IntraGel Therapeutics. "We see this collaboration as an important validation of our SRGel platform and the clinical potential of our lead investigational product, TumoCure, while creating a strong pathway to accelerate development across multiple oncology indications."

"This agreement represent an important step in expanding UroGen’s oncology pipeline and our technological capabilities," said Liz Barrett, President and Chief Executive Officer of UroGen Pharma. "IntraGel’s biodegradable, sustained-release technology complements our expertise in local drug delivery while creating significant optionality for future innovation. Beyond the opportunity to advance TumoCure, we believe the SRGel platform could potentially enable multiple therapeutic approaches across a range of solid tumors and provide a foundation for new product opportunities over time."

Dr. Siman added, "In parallel, we are continuing to advance additional therapeutic candidates in our pipeline based on the broadly applicable SRGel platform including our internally developed IG-003 with GLP-1 analogues for weight management, and monoclonal antibody and peptide programs developed through ongoing collaborations."

SRGel is a biodegradable depot technology designed to enable sustained release of therapeutic agents over extended periods. The platform’s flexibility supports multiple therapeutic modalities and indications. In oncology, SRGel has potential applicability across a broad range of solid tumor settings, including bladder, skin, brain, gastrointestinal and testicular cancers, creating opportunities for future localized oncology treatments beyond the initial collaboration programs.

TumoCure is an investigational cisplatin product formulated with IntraGel’s proprietary SRGel platform, designed to enable prolonged localized drug exposure while limiting systemic exposure. Presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, Phase 1b clinical data demonstrated that TumoCure was generally safe and well tolerated, showed low systemic cisplatin exposure, and provided early indications of anti-tumor activity in a heavily pretreated patient population, including patients with cisplatin treatment-resistant disease1. Investigators also reported improvements in tumor-related symptoms in certain patients. These findings support continued clinical development of TumoCure and further expansion of the SRGel platform as a potential approach for sustained local therapy across additional solid tumors while minimizing systemic exposure.

About SRGel

SRGel is IntraGel’s proprietary injectable hydrophobic gel-like drug delivery platform designed to enable sustained, tailored drug release. Built on a proprietary water-free and solvent-free fatty-acids based polymer matrix, SRGel is engineered to provide controlled, and prolonged release of therapeutics agents following a single administration, with applicability for both localized delivery at the target site and sustained systemic exposure. The technology is designed, when injected intratumorally, to maintain high local drug concentrations while minimizing systemic exposure and associated toxicities. SRGel is compatible with a broad range of therapeutic modalities, including small molecules, peptides and biologics, and may be applicable across therapeutic areas and indications, including weight loss management and inflammatory diseases.

About TumoCure

TumoCure is IntraGel’s lead product candidate and the first clinical application of the SRGel platform. TumoCure consists of cisplatin incorporated into the SRGel biodegradable matrix and is administered as a single intratumoral injection. The investigational therapy is designed to provide sustained delivery of cisplatin directly within tumor tissue over several months while limiting systemic exposure. TumoCure is Phase 2-ready and is being developed for patients with locally advanced, inoperable head and neck cancers, who are ineligible for systemic cisplatin-based chemoradiation. IntraGel is pursuing development through the U.S. Federal Drug Administration (FDA)’s 505(b)(2) regulatory pathway and believes the technology may have future applicability across additional solid tumor indications, including lung, brain, gastrointestinal, ovarian and testicular cancers.

(Press release, IntraGel Therapeutics, AUG 20, 2026, View Source [SID1234670258])

On August 20, 2026 Brii Biosciences Limited ("Brii Bio," or the "Company," stock code: 2137.HK), a biotechnology company developing therapies to improve patient health and choice across diseases with high unmet medical need, reported a corporate update and announced its financial results for the six-month period ended June 30, 2026.

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In the first half of 2026, Brii Bio generated additional clinical data supporting its differentiated hepatitis B virus (HBV) functional cure strategy while continuing to expand its internal discovery capabilities and advance its RNA-based technology platforms.

In its HBV clinical program, the Company presented end-of-study data from its Phase 2 ENSURE study at the European Association for the Study of the Liver (EASL) Congress 2026. On July 3, the Company also announced topline end-of-treatment data from its Phase 2b ENRICH and ENHANCE studies. To date, findings across the ENSURE, ENRICH and ENHANCE studies have consistently supported the potential of BRII-179 to improve functional cure outcomes as part of a combination regimen. Detailed data from the ENRICH and ENHANCE studies are expected to be presented in the second half of 2026.

Beyond its HBV portfolio, the Company continued to advance its internal discovery capabilities and invest in the development of RNA-based technology platforms. Subsequent to the reporting period, the first participant was dosed in a clinical study evaluating BRII-5395, an internally discovered mRNA therapeutic vaccine for advanced hepatocellular carcinoma (HCC). This milestone represents the first clinical evaluation of an RNA-based therapeutic originating from Brii Bio’s internal discovery efforts. While BRII-5395 is an mRNA therapeutic vaccine, the Company’s broader RNA platforms encompass multiple RNA modalities. During the first half of 2026, Brii Bio progressed multiple internally discovered candidates across various stages of discovery and preclinical development, including programs that extend the application of its technology platforms into additional therapeutic areas beyond infectious diseases.

With effective cost control measures and optimized operating structure in place, Brii Bio remains well-capitalized, with a cash position of approximately US$260 million as of June 30, 2026, providing financial flexibility to support its late-stage HBV programs and early discovery initiatives.

"Our progress in the first half of the year reflects meaningful advances across both our late-stage HBV portfolio and our expanding discovery capabilities," said Dr. Zhi Hong, Chairman and Chief Executive Officer of Brii Bio. "Data generated across our HBV studies continue to inform our functional cure strategy. At the same time, the initiation of clinical evaluation for BRII-5395 demonstrates our ability to translate internal discovery into pipeline assets. We look forward to sharing additional milestones later this year. Together, these efforts are building a more diversified pipeline and strengthening the foundation for sustainable innovation and long-term value creation."

Corporate and Clinical Updates

HBV Program

Brii Bio continued to advance its HBV pipeline with a focus on achieving higher functional cure rates through novel combination regimens. The Company’s differentiated HBV portfolio, including BRII-179, a recombinant protein-based HBV immunotherapeutic, and elebsiran, an HBV-targeting siRNA, has generated a growing body of clinical data supporting Brii Bio’s functional cure strategy through the completed Phase 2b ENSURE study and ongoing ENRICH and ENHANCE Phase 2b studies.

The Phase 2b ENSURE study was designed to assess the safety and efficacy of combination approaches aimed at improving functional cure outcomes. Cohorts 1-3 evaluated elebsiran in combination with PEG-IFNα compared to PEG-IFNα monotherapy. Cohort 4 evaluated the potential role of BRII-179 in enhancing immune responsiveness and improving hepatitis B surface antigen (HBsAg) loss rates. In the first half of 2026, end-of-study data from Cohorts 1-4 of the Phase 2 ENSURE study were presented at EASL 2026, demonstrating that:

The HBsAg loss benefit observed in the elebsiran and PEG-IFNα combination cohorts resulted in a higher functional cure rate compared to the PEG-IFNα alone cohort.
BRII-179-experienced participants achieved higher functional cure rates, particularly among anti-HBs responders, suggesting that BRII-179 may play an important role in achieving durable immunological control of HBV.

To further define the role of BRII-179 in HBV treatment and identify an optimal combination regimen for potential registrational development, the Company is evaluating BRII-179 in two additional ongoing Phase 2b studies: ENRICH and ENHANCE studies.

The ENRICH study evaluates BRII-179 as a priming therapy administered prior to elebsiran and PEG-IFNα treatment. The ENHANCE study evaluates a concurrent triple combination regimen of BRII-179, elebsiran, and PEG-IFNα to enhance the functional cure rates. In July, the Company announced topline end-of-treatment data from its Phase 2b ENRICH and ENHANCE studies.

At EOT, the ENRICH study evaluating pre-treatment with BRII-179 followed by elebsiran and PEG-IFNα achieved HBsAg loss rates of 42.9% (42/98) and 40.0% (20/50) across two BRII-179 dosing schedules (five doses administered every 3 weeks and 7 doses administered every 2 weeks, respectively). These results were consistent with the 41.9% (13/31) HBsAg loss rate observed in ENSURE Cohort 4 among patients previously treated with BRII-179, supporting the potential immune-priming role of BRII-179.
Subgroup analyses from the ENRICH study suggest potential differentiation in subjects with higher baseline HBsAg levels (1000-3000 IU/mL) comparing with other HBV functional cure regimens under development by other companies, consistent with prior findings from ENSURE Cohort 4, indicating that BRII-179 may induce beneficial immune responses regardless of baseline HBsAg levels in this difficult-to-treat population.
At EOT, the ENHANCE (Part A-1) study evaluating a concurrent triple combination did not demonstrate improved HBsAg loss rates compared with ENSURE Cohorts 2 and 3, 29.7% (11/37), with an observed rate of 25.5% (25/98). Higher HBsAg loss rates, however, were observed compared with the PEG-IFNα control arm, 10.2% (5/49).
The ENHANCE study also evaluated a sequential approach designed to potentially shorten PEG-IFNα therapy in its Part A-2 by administering BRII-179 plus elebsiran during the first 24 weeks followed by 24 weeks of elebsiran and PEG-IFNα. At EOT, this combination regimen achieved an HBsAg loss rate of 22.5% (18/80), suggesting that a full course of PEG-IFNα therapy may be important for achieving optimal functional cure outcomes.
No new safety concerns have been identified across ENSURE, ENRICH and ENHANCE to date.

On August 19, 2026, the Company received an email notification from one of its central laboratory service providers of a product recall involving a commercial assay kit[1] used for HBsAg testing in the ENHANCE study. Based on the information currently available and the Company’s preliminary assessment, the potential impact on the clinical data of the Company’s sponsored trials publicly disclosed to date appears limited to the EOT HBsAg data for Part A-2 of the ENHANCE study. The Company is working with the service provider to identify potentially affected samples and arrange retesting using unaffected assay kits. Subject to completion of the retesting and further analysis, as at the date of this announcement, the Company has not identified any indication at this stage that the matter would materially affect its overall interpretation of the study results or the program development decisions announced to date. The Company will continue to evaluate the matter and provide updates as appropriate if any material developments arise.

The Company plans to present detailed data from the ENRICH and ENHANCE studies, including additional efficacy, safety and subgroup analyses, at a scientific conference in the second half of 2026.

Discovery Program Update

Brii Bio is expanding its RNA platforms beyond infectious diseases into new therapeutic areas. In the first half of 2026, the Company progressed multiple early-stage candidates spanning various stages of discovery and pre-clinical development, with a focus on generating differentiated therapeutic opportunities in diseases with significant unmet medical needs.

BRII-5395 is a novel mRNA therapeutic vaccine internally developed by Brii Bio. It is being evaluated as part of a combination immunotherapy approach for HBV-related HCC.

On August 12, 2026, subsequent to the reporting period, the first participant was dosed in a clinical study evaluating BRII-5395 in participants with advanced HCC. The study, conducted at the Cancer Hospital of the Chinese Academy of Medical Sciences, is designed to evaluate the safety, tolerability, immunogenicity and preliminary anti-tumor activity of BRII-5395 in combination with an anti-PD-1 antibody and an anti-VEGF antibody. The current standard of care of immune checkpoint inhibitors have limited efficacy against HCC.
As the first internally developed mRNA-based cancer therapeutic vaccine from Brii Bio to enter clinical evaluation, BRII-5395 represents an important milestone in the advancement of the Company’s internal discovery capabilities and RNA-based technology platform.
While BRII-5395 is an mRNA therapeutic vaccine, the Company’s broader RNA platforms encompass multiple RNA modalities. In addition, the Company has extended the application of its technology platforms into additional therapeutic areas beyond infectious diseases.

Further program updates are expected throughout the remainder of 2026. The Company is actively exploring partnership opportunities to advance selected discovery programs to maximize the value of its emerging pipeline.

Additional Clinical Programs

Brii Bio is actively seeking strategic partnerships for long-acting anti-HIV and multidrug resistant (MDR) antibacterial therapeutic candidates to maximize the development and commercialization potential.
Other Corporate Updates

On April 16, 2026, the Company and Brii Biosciences Offshore Limited, a subsidiary of the Company, submitted a Demand for Arbitration to the United States-based Judicial Arbitration and Mediation Services, Inc. against Vir Biotechnology, Inc. (the "Arbitration").

The Company announced the commencement of the Arbitration on April 16, 2026 and provided a further update on May 22, 2026. As of June 30, 2026, the Arbitration remained in its early stages, and the parties had not reached a resolution of the claims.

In light of the ongoing arbitration, the Company is not currently advancing elebsiran into Phase 3 development and future development plans for elebsiran remain under evaluation pending resolution of the Arbitration. The Company will continue to monitor developments and update shareholders as appropriate.

Outlook

Looking ahead, the Company remains focused on advancing its differentiated HBV portfolio while continuing to progress its RNA-based discovery efforts.

The Company plans to continue investing in its internal discovery capabilities and RNA platform to support the advancement of future pipeline candidates. Through these efforts, Brii Bio aims to generate new therapeutic opportunities and build a sustainable pipeline of innovative medicines addressing diseases with significant unmet medical needs.

With a strong balance sheet and disciplined execution, Brii Bio is well positioned to pursue value-creating opportunities and deliver on its strategic priorities.

Interim 2026 Financial Results

The Company maintains a strong cash position to support its operations through 2029. Our bank deposits and cash and cash equivalents were RMB1,770.8 million as of June 30, 2026, representing a decrease of RMB170.2 million or 8.8% compared with RMB1,941.0 million as of December 31, 2025. The decrease was primarily due to payout of research and development activities and daily operations.
Through pipeline prioritization, resource optimization, internalization of certain clinical development activities, and cost-saving measures of third-party vendors, we have effectively controlled our operational expenses. Research and development expenses were RMB98.3 million for the six months ended June 30, 2026, representing a decrease of RMB18.7 million or 16.0%, compared with RMB117.0 million for the six months ended June 30, 2025. The decrease was primarily attributable to organizational optimization, compensation framework adjustments, and lower third-party contracting costs as Phase 2 study activities for the HBV programs wound down, partially offset by increased investment in early-stage discovery.
Administrative expenses were RMB52.6 million for the six months ended June 30, 2026, representing a decrease of RMB5.6 million or 9.6%, compared with RMB58.2 million for the six months ended June 30, 2025. The decrease primarily reflected lower employee costs following organizational optimization and adjustments to the senior management compensation framework, partially offset by the increase in professional fees and the depreciation and amortization cost.
Other income was RMB19.5 million for the six months ended June 30, 2026, representing a decrease of RMB8.6 million or 30.6%, compared with RMB28.1 million for the six months ended June 30, 2025. This was mainly due to the decrease in bank interest income of RMB7.9 million attributable to the declining interest rates on time deposits.
Conference Call Information

The Company will host a live conference call in Chinese on August 21 at 8:30 a.m. HKT (8:30 p.m. ET on August 20). For the registration link, please click here.

All participants shall use the link provided above to complete the online registration process prior to the conference call. A replay of the conference call will be available after the call and can be accessed by visiting the Company’s website at www.briibio.com under the Investor Relations section.

This press release contains references to third-party information. Such information is not deemed to be incorporated by reference in this press release. Brii Bio disclaims responsibility for such third-party information.

(Press release, Brii Biosciences, AUG 20, 2026, View Source [SID1234670259])

On August 19, 2026 Biodexa Pharmaceuticals PLC (Nasdaq: BDRX) ("Biodexa" or "the Company"), a clinical stage biopharmaceutical company developing innovative products focused on the treatment or prevention of gastrointestinal cancers reported that it has exceeded the half-way point in the recruitment of subjects in its registrational Phase 3 trial of eRapa in Familial Adenomatous Polyposis (FAP), NCT06950385. As of today, 87 of a planned 168 subjects have been recruited into the Serenta trial. The trial is recruiting at 29 clinical sites across the US and five countries in Europe with a further three sites in Canada expected to be initiated shortly.

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The Company is planning a futility analysis after 25 Progression Free Survival (PFS) events and database lock after 75 PFS events in the Serenta trial. The Serenta protocol includes a composite endpoint which defines the nature of the PFS events.

Commenting, Stephen Stamp, Chief Executive Officer of Biodexa said "I should like to thank our collaborators at the leading FAP treatment centers who have helped drive recruitment in Serenta and put us ahead of any competition."

About Familial Adenomatous Polyposis

FAP is characterized by the proliferation of polyps in the colon and/or rectum, usually occurring in mid-teens. There is no approved therapeutic option for treating FAP patients, for whom active surveillance and surgical resection of the colon and/or rectum remain the standard of care. If untreated, FAP typically leads to cancer of the colon and/or rectum. There is a significant hereditary component to FAP with a reported incidence of one in 5,000 to 10,000 in the US and one in 11,300 to 37,600 in Europe. eRapa has received Orphan Drug Designation in the US and in Europe. Importantly, mTOR has been shown to be over-expressed in FAP polyps – thereby underscoring the rationale for using a potent and safe mTOR inhibitor like eRapa to treat FAP.

About eRapa
eRapa is a proprietary oral capsule formulation of rapamycin, also known as sirolimus. Rapamycin is an mTOR (mammalian Target Of Rapamycin) inhibitor. mTOR has been shown to have a significant role in the signalling pathway that regulates cellular metabolism, growth and proliferation and is activated during tumorigenesis. Importantly, mTOR has been shown to be over-expressed in FAP polyps – thereby underscoring the rationale for using a potent and safe mTOR inhibitor like eRapa to treat FAP. Data from an open label Phase 2 trial were presented at Digestive Disease Week and InSIGHT 2024 in May and June 2024, respectively. Based on those data, Biodexa initiated a double-blind, placebo-controlled Phase 3 registrational trial which is planned to initiate 30 clinical sites across the US and Europe and to enrol 168 subjects randomized 2:1, drug: placebo. The Phase 3 program is supported by a $20 million grant from the Cancer Prevention and Research Institute of Texas.

(Press release, Biodexa Pharmaceuticals, AUG 19, 2026, View Source [SID1234670243])