SUZHOU, China, March 2, 2026 /PRNewswire/ — In February 2026, XellSmart Pharmaceutical Co., Ltd. (XellSmart) announced that it had secured its fourth US FDA and China NMPA clearance for Phase I/II registrational clinical trial entry with its independently developed, off-the-shelf, allogeneic, universal, iPSC-derived, subtype-specific neuron progenitor cell therapy targeting Multiple System Atrophy- Parkinsonian Type (MSA-P). This joins the previous three consecutive FDA-NMPA registrational trial clearances for its universal iPSC-derived cell therapies targeting Parkinson’s Disease (PD), Spinal Cord Injury (SCI), and Amyotrophic Lateral Sclerosis (ALS), respectively. Building on its promising clinical data, the rapid pipeline progress fully attests to XellSmart’s expertise in iPSC-for-CNS space, the potential clinical value and viability for its products, and its unwavering commitment in addressing the unmet clinical needs in the highly underserved neurodegenerative disease field. 

MSA, recognized by the World Health Organization (WHO) as a rare and fatal neurodegenerative disease with huge unmet needs, meets with this commitment. The Parkinsonian type of multiple system atrophy (MSA-P) mainly presents with progressive Parkinsonian syndrome, such as bradykinesia, rigidity, and gait disorders, accompanied by severe autonomic nerve dysfunction, including orthostatic hypotension and urinary incontinence. This disease is triggered by abnormal aggregation of α-synuclein in oligodendrocytes, causing extensive loss of neuronal function and rapid progress. The median survival for patients after diagnosis is merely 6 to10 years. 

Although MSA-P has a wider pathological scope than Parkinson’s disease, the two diseases overlap to a certain extent in their pathogenesis, especially in the manifestation of Parkinsonian motor symptoms. The current standard clinical treatment for MSA-P includes dopaminergic drugs for Parkinson’s-like motor symptoms, such as levodopa/carbidopa, combined with other dopaminergic therapies when necessary. However, the overall response is often not as good as that for Parkinson’s disease and the efficacy is limited. Non-pharmacological treatments for MSA-P includes management of autonomic dysfunction and rehabilitation training, fall prevention and nutritional support to maintain patients’ physical function and quality of life as much as possible. 

Currently, there are no approved therapies anywhere in the world that can effectively slow or reverse the disease progression. Yet, XellSmart’s innovative approach attempts to address this challenging neurodegenerative disease. Through employing a potential mechanism of regenerating dopamine secretion and promoting circuit and brain environment repair, it explores this novel treatment approach for MSA-P, and the potential to deliver a new therapeutic option and hope to patients worldwide.

Standing at the Forefront of iPSC-derived Cell Therapies for CNS Diseases 

This pipeline extension into MSA-P naturally taps into XellSmart’s expertise in CNS diseases, evidenced by its multiple cleared “China or global first” INDs. Overall, nine INDs from XellSmart have been cleared by US FDA and China NMPA for Phase I/II registrational clinical trials. These commenced trials employ clinical-grade, allogeneic, universal, off-the-shelf, iPSC-derived cell therapeutic products — the laser-sharp development focus of the company, all targeting major or critical CNS diseases, i.e., Parkinson’s Diseases, Spinal Cord Injury, ALS and MSA-P. The key trials are:

• China Phase I/II & the US Phase I registrational clinical trials, targeting primary Parkinson’s disease, the world’s second most prevalent neurodegenerative disorder. The trial is led by a prestigious National Center for Neurological Disorders — Beijing Tiantan Hospital.
• China’s first randomized, double-blind, controlled clinical trial of universal cell therapy, targeting early-onset Parkinson’s disease. The trial is led by Huashan Hospital Fudan University, a leading National Center for Neurological Disorders.
• China and the US Phase I/II registrational clinical trials targeting MSA-P, projected to be kicked off in 2026.
• China and the US Phase I registrational clinical trials targeting Spinal Cord Injury, employing XellSmart’s potentially First-in-Class product, led by the Third Affiliated Hospital of Sun Yat-sen University.
• China Phase I/II & the US Phase I registrational clinical trials, targeting Amyotrophic Lateral Sclerosis (ALS). The trial employs the first China-developed iPSC-derived cell therapy that had received Orphan Drug Designation from the US FDA in 2023. The trial is led by Peking University Third Hospital.

Key Clinical Results Emerged from PD Registrational Trials

This pipeline extension into MSA-P also builds on XellSmart’s promising clinical data in PD trials. The trials carried out at the National Centers for Neurological Disorders have enrolled more than a dozen patients with moderate to severe PD. After receiving cell transplantation treatment, these patients showed:

• No unexpected safety signals observed to date.
• A positive trend for efficacy indicators such as ‘ON/OFF state’ and MDS-UPDRS motor scores. The average “ON state” has been extended by several hours, coupled with a significant relief in “OFF state”, in contrast to pre-treatment difficulty in movement and significant limitations after medication failure. The time for daily free movement and maintaining a relatively high quality of life has significantly increased.
• A trend of long-term survival and maturation of the engrafted neurons, as brain PET examination suggests potential survival and function from newly generated dopaminergic cells in the putamen region.

The clinical results demonstrated XellSmart’s clinical implementation capability and the significant clinical potential of using iPSC-derived cell therapies via stereotactic neurosurgery for safe and effective PD treatment.

A Strong Market Vote of Confidence Following Regulatory Votes of Confidence

Since its inception in 2021, XellSmart has embraced rapid clinical development and GMP-grade facility upgrade supported by five consecutive years of market-driven funding, collectively led by renowned venture capital firms including FreeS Fund, Qiming Venture Partners, LAV, Sequoia Capital China (Hongshan), 3SBIO and more.

The proceeds from this financing have been boosting its key pipeline products into pivotal validation clinical stages. Additionally, the funds will ensure future commercial roll-out of XellSmart’s products through strengthening XellSmart’s fully-fledged, large-scale, standardized production capacity, quality management and control systems for its off-the-shelf iPSC-derived cell products. A firm market vote of confidence, underpinned by successive regulatory votes of confidence by the NMPA and FDA.

About XellSmart

XellSmart is a clinical-stage, regenerative medicine company focusing on treating CNS diseases with clinical-grade, allogeneic, universal, off-the-shelf, iPSC-derived cell therapies. Founded by Dr. Xiang Li (Michael Lee) in 2021 in Suzhou and Shanghai, China, the company has built up a strong portfolio of global patents and secured US FDA and China NMPA clearance for nine INDs of allogeneic iPSC-derived cell therapies targeting major or critical CNS diseases: Parkinson’s Diseases, Spinal Cord Injury, ALS and MSA-P, moving wholly-owned cell therapeutic products through clinical developments in China and the US, based on its own 5,000㎡ R&D center, B+A-grade GMP manufacturing facility, and quality control center in Shanghai and Suzhou, China. XellSmart, standing at the forefront of iPSC-derived cell therapies for underserved CNS diseases, is committed to transforming this disease treatment landscape and helping millions of suffering patients with its cutting-edge innovation.   

CONTACT:
BD@xellsmart.com

PHILADELPHIA, March 2, 2026 /PRNewswire/ — LongBio Pharma (Suzhou) Co., Ltd. (“LongBio”), a clinical-stage biotech company focused on discovery and development of biologics targeting allergic and autoimmune diseases, proudly announced positive topline results from a Phase II clinical trial of its next-generation anti-IgE antibody, LP-003, with a head-to-head comparison with Xolair^® (Omalizumab). The data was presented as a late-breaking poster at the 2026 AAAAI Annual Meeting. The results demonstrated that LP-003 achieved comprehensive clinical advantages over omalizumab, with statistically superior outcomes in the key efficacy endpoints.

The trial (NCT06228560, CTR20233300) is a multicenter, randomized, double-blind, placebo and active drug (Omalizumab) controlled Phase II study, designed to evaluate the efficacy and safety of LP-003 in patients with chronic spontaneous urticaria (CSU) who remain symptomatic despite antihistamine (H1) treatment. A total of 202 patients were enrolled and randomly assigned to one of three LP-003 treatment groups (100 mg Q4W, 200 mg Q4W, 200 mg Q8W), the Omalizumab group (300 mg Q4W), or the placebo group, with a total treatment duration of 24 weeks. 

In this head-to-head trial against Omalizumab, LP-003 exhibited comprehensive superiority in efficacy, a fast onset of action, and a favorable safety profile, further confirming its potential as a best-in-class anti-IgE therapy.

LP-003 Demonstrates Comprehensive Efficacy Superiority and Fast onset Over Omalizumab

For the primary endpoint, at Week 12, the proportions of patients achieving UAS7=0 were 44.4%, 66.7%, 57.5%, 43.6% and 10.8% in the LP-003 100 mg Q8W, 200 mg Q8W, 200 mg Q4W, Omalizumab, and placebo groups, respectively (200 mg Q8W vs. Omalizumab, p=0.0405).

For the second key efficacy endpoint, LS mean changes from baseline in UAS7 at Week 12 were -23.15, -26.63, -24.74, -21.85 and -13.98 in the LP-003 100 mg Q8W, 200mg Q8W, 200 mg Q4W, Omalizumab, and placebo groups, respectively (200 mg Q8W vs. Omalizumab, p=0.0137). 

By Week 4, the complete remission rate across LP-003 groups reached 35%-35.9%. Compared to Omalizumab, LP-003 showed fast onset efficacy.

LP-003 demonstrated statistically significant and clinically meaningful superiority compared to Omalizumab in two key efficacy endpoints, along with a favorable safety profile.

The leading indication of LP-003 is seasonal allergic rhinitis (SAR), which is expected to submit Biologics License Application (BLA) to NMPA (China FDA) in or before the third quarter of 2026. Once approved, LP-003 would become the first and only innovative anti-IgE drug to be launched globally in over 20 years since the approval of Omalizumab.

About LongBio

LongBio is a clinical-stage biotech company. Established in 2020 and located in Shanghai and Suzhou, China, LongBio primarily focuses on the in-house discovery and development of biologics targeting on allergic and autoimmune diseases.

LP-003 is an novel anti-IgE antibody developed by LongBio for the treatment of allergic diseases, including seasonal AR, CSU, allergic asthma, CRSwNP and food allergy. Compared with Xolair (Omalizumab), LP-003 has a 860-fold greater IgE binding affinity and 30-fold higher blocking activity. In addition to its potent bioactivity, LP-003 has a much longer half-life over Omalizumab.

The Phase III clinical trial in China for seasonal AR indication has completed patient enrollment, with BLA submission to NMPA planned in or before Q3 2026. A Phase III trial for CSU in China is expected to start in H1 2026.

For more information, please visit www.longbio.com or contact bd@longbio.com. 

Milestone marks the first clinical program for Charcot-Marie-Tooth disease and Vanishing White Matter disease.

SAN FRANCISCO and SHANGHAI, March 2, 2026 /PRNewswire/ — ReviR Therapeutics, a clinical-stage biotechnology company pioneering AI-driven RNA-modulating small molecules to treat rare and genetic diseases, today announced a pivotal clinical and dual regulatory milestone: the first participant has been dosed in the First-in-Human (FIH) Phase 1 clinical trial of its lead candidate, RTX-117. This clinical progress follows the recent clearance by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) of Investigational New Drug (IND) applications for two rare neurological indications: Charcot-Marie-Tooth disease (CMT) and Vanishing White Matter disease (VWM). The pipeline has also received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA), enabling the expansion of its clinical program into the United States.

The Phase 1 study is a randomized, double-blind, placebo-controlled, dose-escalation trial designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of RTX-117 in healthy participants, supporting the transition into subsequent clinical trials for patients with CMT and VWM.

Advancing Treatment for Rare Neurological Disorders

The severity of these diseases targeted in ReviR’s clinical trials underscores the urgency of ReviR’s mission, while the clearance further validates the unmet need for patients in China and worldwide:

• Charcot-Marie-Tooth disease (CMT): A spectrum of progressive and debilitating inherited disorders that cause nerve damage, resulting in muscle atrophy and loss of sensation in the extremities, with some subtypes leading to high mortality rates.
• Vanishing White Matter disease (VWM): A progressive and catastrophic leukodystrophy that primarily affects children, leading to irreversible motor decline and cognitive deterioration, often with fatal outcomes.

“The milestone is a testament to the rigor of our preclinical data and the efficiency of our global team,” said Paul August, PhD, Chief Scientific Officer of ReviR. “We are committed to working closely with clinical investigators and patient organizations in China to bring these innovative therapies forward as safely and rapidly as possible.”

“The initiation of dosing in our first-in-human study, coupled with the dual IND clearance in China, marks a transformative leap for ReviR Therapeutics,” added Peng Yue, PhD, CEO of ReviR. “By leveraging our VoyageR AI platform and our integrated cross-border operations in the U.S. and China, we are accelerating the development of our small molecule pipelines designed to address critical gaps where no approved disease-modifying treatments exist.”

VoyageR AI is Fundamental to Disease Strategy

RTX-117 has previously received IND approval and Orphan Drug Designation from FDA, and it is also currently the only pipeline in China granted IND clearance for both CMT and VWM. It was discovered and developed using ReviR’s proprietary VoyageR AI platform in collaboration with XtalPi’s AI+robotics drug discovery engine. By leveraging deep insights into RNA biology and protein translation homeostasis, RTX-117 acts on the Integrated Stress Response (ISR) pathway to restore normal protein expression at the molecular source. Beyond the lead program, the VoyageR platform serves as a powerful engine for precision medicine, identifying chemical starting points based on their specific impact on RNA splicing. This enables the modulation of protein expression at the genetic source, empowering ReviR to target complex neurological conditions, immune & inflammatory pathways, and beyond – that have long been considered “undruggable.”

About ReviR Therapeutics

ReviR Therapeutics is a global biotechnology company committed to discovering and developing innovative therapies for patients with serious genetic diseases. ReviR was founded in 2021 by leaders in computational biology, RNA biology, genomics, and drug discovery, with the aim to create disease-modifying therapies that are highly specific, efficacious, and safe. ReviR’s lead candidate, RTX-117, is an investigational small molecule therapy for Charcot-Marie-Tooth disease (CMT)/Vanishing White Matter disease (VWM). In addition, ReviR’s pipeline includes other orally administered small molecules designed to modulate RNA function by splicing. For more information about ReviR Therapeutics, visit www.revirtx.com.

About RTX-117

RTX-117 is a potential first-in-class, orally administered small molecule therapy developed by ReviR Therapeutics, with discovery and molecular design powered by XtalPi’s AI and robotics drug discovery platform. The therapy targets the Integrated Stress Response (ISR) pathway by activating eIF2B, a key protein translation initiation factor. By restoring protein synthesis homeostasis and improving neuromuscular function, RTX-117 aims to address the underlying molecular pathology of related genetic disorders. The candidate is currently undergoing a Phase 1 clinical trial, with Investigational New Drug (IND) clearance already secured for both Charcot-Marie-Tooth disease (CMT) and Vanishing White Matter disease (VWM).

Forward-Looking Statements

This press release contains forward-looking statements regarding ReviR Therapeutics’ clinical trials and regulatory pathways. Actual results may differ materially based on clinical outcomes and regulatory decisions.

TAIPEI, March 2, 2026 /PRNewswire/ — GigaMedia Limited (NASDAQ: GIGM) today announced that the Company has entered into and executed with Aeolus Robotics Corporation (“Aeolus”) an agreement of amendment to the Aeolus convertible promissory note previously purchased by GigaMedia on August 31, 2020 (the “Note”). This amendment is the second amendment to further extend the due date of the Note for the outstanding US$7 million principal, with advantageous terms and conditions.

For the further amended Note, the outstanding principal of US$7 million bearing an interest rate of 4% per annum, shall be due on May 31, 2026, and all or a portion of the principal amount under the further amended Note may be convertible upon maturity, upon prepayment or occurrence of certain events, upon its next round equity financing, or upon its initial public offering, at the lower of US$1.25 per share or 80% of the offering prices if applicable.

The agreement was entered into for the purpose of supporting Aeolus in carrying out its recent financing activities. GigaMedia continually reviews its investment alternatives and may enter into additional transactions of Aeolus’s securities from time to time in accordance with applicable laws.

About GigaMedia

Headquartered in Taipei, Taiwan, GigaMedia Limited (Singapore registration number: 199905474H) is a diversified provider of digital entertainment services in Taiwan and Hong Kong. GigaMedia’s digital entertainment service business is an innovative leader in Asia with growing capabilities of development, distribution and operation of digital entertainments, as well as platform services for games with a focus on mobile games and casual games. More information on GigaMedia can be obtained from www.gigamedia.com.

The statements included above and elsewhere in this press release that are not historical in nature are “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. GigaMedia cautions readers that forward-looking statements are based on the Company’s current expectations and involve a number of risks and uncertainties. Actual results may differ materially from those contained in such forward-looking statements. Information as to certain factors that could cause actual results to vary can be found in GigaMedia’s Annual Report on Form 20-F filed with the United States Securities and Exchange Commission in April 2025.