China Healthcare Weekly – 20th January 2026
This week’s China healthcare highlights include WuXi XDC’s acquisition of TOT Biopharm to expand ADC CDMO capabilities, Sino Biopharma’s entry into RNAi therapeutics with the acquisition of Hygieia, and RemeGen’s US$ 5.6 billion licensing deal with AbbVie. IPO filings by Exegenesis, Immvira, and Genhouse Bio, along with licensing deals from Zonsen, MediLink, and SciNeuro, underscore progress in gene therapy, ADCs, and radioligand therapeutics. Clinical breakthroughs, including approvals for Hengrui’s bifunctional fusion protein and Sunshine Lake’s SGLT2 inhibitor, reflect significant advancements in addressing unmet medical needs.
Transactions & BD (In/Out Licensing)
WuXi XDC (2268.HK) to Acquire TOT Biopharm (1875.HK) to Expand ADC CDMO Capabilities
Key Words: WuXi XDC, TOT Biopharm, CDMO, antibody-drug conjugates, bioconjugates, acquisition, manufacturing
The News: WuXi XDC has announced a cash offer to acquire Chinese compatriot TOT Biopharm, aiming to expand its manufacturing capacity and strengthen its leadership in the antibody-drug conjugate (ADC) and bioconjugate contract development and manufacturing organization (CDMO) sector.
Key Highlights:
- The acquisition aligns with WuXi XDC’s 2025 preliminary financial results, which forecast more than 45% revenue growth and over 45% adjusted net profit growth year-on-year.
- This strategic move addresses rising capacity constraints in the bioconjugate industry as more ADC drugs approach commercialization.The deal enables WuXi XDC to integrate TOT Biopharm’s established production facilities and operational expertise, avoiding the lengthy construction timelines for new manufacturing sites.
Sino Biopharma (1177.HK) Acquires RNAi Firm Hygieia for RMB 1.2 Billion
Key Words: Sino Biopharmaceutical, Hygieia Pharmaceuticals, RNAi, siRNA, Kylo-11, acquisition, MVIP platform, lipoprotein(a), cardiovascular and metabolic diseases
The News: Sino Biopharmaceutical has announced a definitive agreement to acquire Hygieia Pharmaceuticals, a Chinese siRNA therapeutics company, for RMB 1.2 billion (US$ 167 million). This acquisition marks a strategic entry by Sino Biopharmaceutical into the small nucleic acid drug space.
Key Highlights:
- Hygieia’s flagship asset, Kylo-11, is a potential best-in-class siRNA drug aimed at lowering lipoprotein(a) [Lp(a)]. Leveraging the proprietary MVIP liver-targeting platform, Kylo-11 is designed for once-yearly subcutaneous administration and is currently in Phase II clinical trials in both China and the US.
- Founded in 2018, Hygieia is a pioneer in siRNA development with a seasoned R&D team and over 50 core patents. The company has built an integrated drug discovery platform and has a robust pipeline of more than 20 preclinical and 4 clinical-stage assets targeting metabolic, cardiovascular, and neurological diseases.
- The acquisition strengthens Sino Biopharmaceutical’s pipeline in next-generation cardiovascular and metabolic therapies, complementing its existing portfolio in respiratory, hepatic, and autoimmune diseases.
RemeGen (9995.HK) Licenses PD1×VEGF BsAb to AbbVie (NYSE: ABBV) in US$ 5.6 Billion Deal
Key Words: RemeGen, AbbVie, PD1×VEGF, bispecific antibody, RC148, licensing, oncology, US$ 5.6 billion, NSCLC, ADCs
The News: China-based RemeGen has entered into a licensing agreement with AbbVie, granting AbbVie exclusive rights to develop and commercialize its PD1×VEGF bispecific antibody (BsAb), RC148, outside of Greater China. The deal is valued at up to US$ 5.6 billion, including an upfront payment of US$ 650 million and up to US$ 4.95 billion in milestone payments.
Key Highlights:
- RemeGen is also eligible for tiered royalties in the low double-digit percentages on ex-China net sales of RC148.
- RC148 has demonstrated promising Phase I/II data in non-small cell lung cancer (NSCLC), showing efficacy both as a monotherapy and in combination with docetaxel, particularly in patients who have progressed on prior PD-(L)1 inhibitor therapy.
- The candidate is part of the competitive global field of PD-(L)1×VEGF bispecific antibodies and is being developed for use in combination with antibody-drug conjugates (ADCs), an area where RemeGen has extensive expertise.
Exegenesis Bio Files for Hong Kong IPO to Advance Gene Therapy and Oligonucleotide Pipeline
Key Words: Hong Kong IPO, HKEX, AAV gene therapy, oligonucleotide therapeutics, AAVarta
The News: Exegenesis Bio, a gene therapy and oligonucleotide-focused biopharmaceutical company founded in 2019 and headquartered in Hangzhou, Zhejiang, has formally submitted its IPO application to list on the Hong Kong Stock Exchange. The company previously reached a post-money valuation of US$ 577 million (approximately RMB 4 billion) in June 2021 and has not conducted further private financing since, moving directly to a Hong Kong listing based on the strength of its technology platforms and clinical pipeline.
Exegenesis Bio has established two proprietary platforms—AAVarta, an AI-assisted AAV capsid evolution and discovery platform, and SODA, a silencing oligonucleotide design approach—enabling precise gene delivery and optimized oligonucleotide design to maximize therapeutic efficacy.
Key Highlights
- Clinical-stage AAV programs:
- EXG001-307 (SMA type 1): Received NMPA IND approval in June 2022 for the treatment of SMA type 1. A Phase I/II trial with intravenous administration in Chinese patients has been completed, demonstrating a tolerable safety profile and notable efficacy compared with published data for approved SMA therapies.
- EXG102-031 (wAMD): An AAV-based gene therapy for wet age-related macular degeneration (wAMD). IND clearance was obtained from the US FDA in January 2023 and from the NMPA in June 2023. Ongoing Phase I/II studies in China and the US are evaluating safety, tolerability, and preliminary efficacy in wAMD patients.
- EXG202 (ocular neovascular diseases): An AAV-based gene therapy for wAMD, diabetic macular edema (DME), and retinal vein occlusion (RVO), with IND approvals from the FDA (July 2025) and NMPA (August 2025). In parallel with IND trials, an investigator-initiated trial (IIT) is assessing safety, tolerability, and biological activity following intravitreal administration in wAMD patients.
- Exegenesis Bio is advancing multiple preclinical AAV and oligonucleotide programs, including:
- EXG110: AAV-based gene therapy for Fabry disease.
- EXG001-307 (SMA types 2 and 3): A gene therapy candidate for SMA type 2 and type 3.
- EXG112: A non-opioid pain program targeting Nav1.7 (SCN9A).
- EXG115: An antibody–oligonucleotide conjugate (AOC) program for Alzheimer’s disease.
- EXG116: An AAV-based gene therapy for Rett syndrome.
- EXG113: An AAV-based gene therapy for dry AMD, including geographic atrophy (GA).
- EXG111: An AAV-based gene therapy for Duchenne muscular dystrophy (DMD).
Zonsen Bio Licenses Peptide-Based Radioligand Therapy Asset to Novartis (SWX: NOVN, NYSE: NVS)
Key Words: Zonsen Biotech, Novartis, radioligand therapy, RLT, peptide-based asset, licensing, oncology, peptide therapeutics
The News: China’s Zonsen Biotech has signed a global licensing and collaboration agreement with Novartis for an undisclosed peptide-based asset in the radioligand therapy (RLT) field. Novartis will gain exclusive worldwide rights to the asset and lead all further development and commercialization efforts.
Key Highlights:
- Zonsen will receive an upfront payment of US$ 50 million and is eligible for additional development, regulatory, and sales milestone payments, as well as tiered royalties on global net sales.
- The asset, fully developed by Zonsen to date, will expand Novartis’ RLT portfolio, aligning with the company’s strategic focus on innovative radiopharmaceuticals.
- Founded in 2017, Zonsen specializes in the discovery and development of novel peptide therapeutics for oncology and cardiovascular metabolic diseases.
- Zonsen’s proprietary peptide library and discovery platform enable the creation of multiple peptide-based modalities, including peptide-radionuclide conjugates (PRCs), peptide-oligonucleotide conjugates (POCs), and peptide-drug conjugates (PDCs).
MediLink Therapeutics Licenses B7-H3 ADC to Roche (SWX: ROG) in New Exclusive Agreement
Key Words: MediLink Therapeutics, Roche, B7-H3, ADC, YL201, TMALIN platform, solid tumours, SCLC, nasopharyngeal carcinoma, licensing
The News: MediLink has signed an exclusive global licensing agreement valued at US$ 570 million in upfront and near-term milestone payments with Roche for the development and commercialization of YL201, a B7-H3-targeting antibody-drug conjugate (ADC).
Key Highlights:
- YL201 is developed using MediLink’s proprietary TMALIN linker-payload platform, designed for targeted release of its cytotoxic warhead within the tumour microenvironment (TME).
- The ADC is currently in global clinical studies for various solid tumours, including two Phase III registrational trials in China for small cell lung cancer (SCLC) and nasopharyngeal carcinoma.
- YL201 has received breakthrough therapy designation (BTD) in the US for SCLC, along with three orphan drug designations.
- Under the terms of the agreement, Roche secures exclusive global rights to YL201 outside of Greater China. MediLink is also eligible for additional development, regulatory, and commercial milestone payments, plus tiered royalties on ex-China net sales.
SciNeuro Pharmaceuticals and Novartis (SWX: NOVN, NYSE: NVS) Sign Global Licensing and Collaboration Agreement for Next‑Generation Alzheimer’s Therapeutics
Key Words: Alzheimer’s disease, amyloid beta, monoclonal antibody, blood–brain barrier shuttle, SNP837, licensing agreement, collaboration, milestones, royalties, CNS, neurodegeneration
The News: SciNeuro announced that it has entered into a worldwide licensing and collaboration agreement with Novartis to advance SciNeuro’s novel amyloid beta–targeted antibody program for the treatment of Alzheimer’s disease. The program has identified de novo antibody candidates that incorporate SciNeuro’s proprietary blood–brain barrier (BBB) shuttle technology, designed to enhance brain delivery of therapeutic agents and offer potential differentiation from existing amyloid beta–targeted therapies.
Key Highlights
- SciNeuro provides Novartis with an exclusive worldwide license to its antibody program leveraging a proprietary BBB shuttle platform to enhance CNS delivery of Alzheimer’s therapeutics. The parties will co‑operate in early development, with Novartis assuming responsibility for later‑stage development and commercialization on a global basis.
- Under the terms of the agreement, SciNeuro will receive an upfront payment of US$ 165 million. SciNeuro is also eligible for research funding and up to US$ 1.5 billion in potential development, regulatory, and commercial milestone payments, in addition to tiered royalties on future net sales. The transaction is expected to close in the first half of 2026.
- Founded in 2020, SciNeuro is a clinical-stage biotech developing disease-modifying therapies for neurodegenerative and CNS diseases, including Alzheimer’s and Parkinson’s. Its pipeline leverages advances in neurovascular inflammation, proteinopathies, and brain immune responses
Immvira Biosciences Refiles for Hong Kong IPO to Advance Oncolytic Virus and Engineered Exosome Pipeline
Key Words: Hong Kong IPO, HKEX, oncolytic immunotherapy, engineered exosomes, MVR‑T3011, HSV‑1, solid tumors
The News: On January 14, 2026, Immvira had its Hong Kong IPO application accepted by the Main Board of the Hong Kong Stock Exchange, with Citi and CICC acting as joint sponsors, and its prospectus was officially published. The company had previously submitted a Main Board listing application on June 25, 2025.
Founded in 2015 and positioned as a clinical‑needs‑driven biotechnology company, Immvira focuses on the discovery, development, manufacturing and commercialization of novel oncolytic immunotherapies and engineered exosome therapies. Its pipeline consists of two oncolytic immunotherapy candidates for solid tumors and five engineered exosome products with clinical application potential or direct commercialization potential.
Key Highlights
- Immvira’s wholly in‑house–developed core product MVR‑T3011 is a Phase II HSV‑1–based oncolytic immunotherapy that combines potent oncolysis with the expression of an anti–PD‑1 antibody and IL‑12. The company is also advancing a portfolio of engineered exosome products targeting chronic, refractory and age‑related diseases, with some programs designed for accelerated commercialization to support broader R&D activities.
- The company currently has no approved products for commercial sale and no product sales to date. During the track record period, revenue was generated from out-licensing and collaboration arrangements, mainly upfront payments, patent license fees, and other consideration from partners. Immvira recorded revenues of RMB 6.772 million, RMB 3.2 million, and RMB 1.305 million for 2023, 2024, and the nine months ended September 30, 2025, respectively.
- Since its inception, Immvira has completed multiple financing rounds, including a US$14.4 million Series C+ round in January 2024, implying a post‑money valuation of approximately US$485 million.
Genhouse Bio Files for Hong Kong IPO to Advance Oncology Pipeline
Key Words: Hong Kong Stock Exchange, IPO, RAS signaling pathway, synthetic lethality, SHP2 inhibitor, GH21, oncology
The News: On January 16, Genhouse Bio, a China-based biopharmaceutical company, submitted its application for an IPO in Hong Kong. The company specializes in developing innovative targeted oncology therapies, with a pipeline focused on the RAS signaling pathway and synthetic lethality mechanisms. Its core product, GH21, a potential best-in-class SHP2 inhibitor, is in Phase II clinical trials, with additional studies ongoing for combination therapies.
Key Highlights:
- Core Product GH21:
- GH21 is a SHP2 inhibitor in Phase II trials for solid tumors, with IND approvals for monotherapy and combination therapies involving Goserelin and Osimertinib.
- Multiple clinical trials, including Phase Ib/II and Phase II studies, are ongoing in China.
- Synthetic Lethality Pipeline:
- GH56: A PRMT5 inhibitor for MTAP-deleted tumors, in Phase I trials.
- GH2616: A KIF18A inhibitor targeting WGD+ tumors, also in Phase I trials.
- Other candidates, including GH31, GH1581, and GH3595, are in preclinical or early clinical stages.
- Genhouse Bio recorded revenues of RMB 4.69 million (2023), RMB 3.732 million (2024), and RMB 0.981 million (9 months ending September 2025), with net losses of RMB -152 million, RMB -96.506 million, and RMB -98.887 million during the same periods.
Clinical
Benethera Receives IND Clearance in US for First-in-Class Oral Treg Inducer
Key Words: IND clearance, BT-101, Treg inducer, oral drug, IBD, inflammatory bowel disease, GPCR, clinical trial, autoimmune diseases
The News: China-based Benethera has received investigational new drug (IND) approval in the United States to initiate a first-in-human clinical trial for BT-101, its first-in-class oral drug candidate designed to induce regulatory T-cells (Tregs) in vivo for the treatment of inflammatory bowel disease (IBD).
Key Highlights:
- The Phase I clinical trial will evaluate the safety, tolerability, and pharmacokinetics of BT-101 in healthy adult volunteers through single and multiple ascending dose cohorts.
- BT-101 is a small molecule targeting a specific G protein-coupled receptor (GPCR) to promote the differentiation of endogenous naive T-cells into functional Tregs within the intestinal immune system.
- The drug leverages oral immune tolerance to restore immune balance in IBD patients, aiming to avoid the broad immunosuppression associated with some existing therapies.
- This IND clearance marks Benethera’s transition to a clinical-stage company, just over four years after its founding in December 2021.
Epigenic Therapeutics’s Epigenetic Editing Therapy Gains Clinical Trial Approval in China
Key Words: EPI-003, epigenetic editing, chronic hepatitis B, CHB, IND approval, HBV, cccDNA, lipid nanoparticle, mRNA therapy, functional cure
The News: Epigenic has received investigational new drug (IND) approval from China’s National Medical Products Administration for EPI-003, an innovative epigenetic regulation therapy for chronic hepatitis B (CHB). This is the first clinical trial approval in China for an epigenetic editing therapy targeting this indication.
Key Highlights:
- EPI-003 previously received IND clearance in the US in December 2025 and is already in Phase I clinical trials across Australia, New Zealand, and Hong Kong.
- The therapy uses a lipid nanoparticle (LNP) delivery system to transport mRNA encoding an epigenetic regulator and guide RNA targeting the hepatitis B virus (HBV) genome in liver cells.
- EPI-003 is designed to induce durable epigenetic modifications to both covalently closed circular DNA (cccDNA) and integrated HBV DNA, suppressing viral products at the transcriptional source.
- Preclinical studies have shown significant and sustained reductions in hepatitis B surface antigen (HBsAg) and HBV DNA levels, with the potential to achieve a functional cure for CHB.
Hengrui Pharmaceuticals (1276.HK, 600276.SS) Gains First Global Approval for Anti-PD-L1×TGF-βRII Bispecific
Key Words: retlirafusp alfa, PD-L1×TGF-βRII, bispecific, gastric cancer, gastroesophageal junction adenocarcinoma, NMPA, first-line therapy, Phase III SHR-1701-III-307, overall survival
The News: Hengrui has received marketing approval from China’s National Medical Products Administration (NMPA) for retlirafusp alfa, a bifunctional fusion protein targeting both PD-L1 and TGF-βRII. Retlirafusp alfa is approved in combination with fluoropyrimidine- and platinum-based chemotherapy as a first-line treatment for patients with locally advanced unresectable, recurrent, or metastatic gastric or gastroesophageal junction adenocarcinoma. This authorization represents the first global approval for a therapeutic agent in this class.
Key Highlights
- Indication and regimen: Retlirafusp alfa is indicated in combination with fluoropyrimidine- and platinum-based chemotherapy for the first-line treatment of locally advanced unresectable, recurrent, or metastatic gastric cancer or gastroesophageal junction adenocarcinoma.
- Pivotal trial: The approval is supported by data from the randomized Phase III SHR-1701-III-307 trial, which enrolled 737 patients with locally advanced unresectable, recurrent, or metastatic disease.
- Efficacy outcome: The study met its primary endpoint, showing that retlirafusp alfa plus chemotherapy significantly improved overall survival (OS) versus chemotherapy alone, with clinically meaningful benefit.
- Safety profile: The combination demonstrated an acceptable and manageable safety profile, without new or unexpected safety signals beyond those associated with PD-L1 inhibition, TGF-β pathway modulation, and standard chemotherapy.
Antengene (6996.HK) Showcases Promising ATG-022 Data and Pipeline Progress in ADCs and TCEs at J.P. Morgan Healthcare Conference
Key Words: ATG-022, CLINCH study, CLDN18.2, antibody-drug conjugate, ADC, T-cell engager, TCE, ATG-125, ATG-106, ATG-110, JPM
The News: Antengene presented updated clinical data for its core asset ATG-022, along with R&D progress for its next-generation antibody-drug conjugates (ADCs) and T-cell engagers (TCEs), at the 44th Annual J.P. Morgan Healthcare Conference. ATG-022, a CLDN18.2-targeting ADC, demonstrated encouraging efficacy and disease control in the ongoing CLINCH study, including in patients with high CLDN18.2 expression and signals of activity beyond gastrointestinal tumors. Antengene also outlined clear development timelines for key pipeline candidates ATG-125, ATG-106, and ATG-110.
Key Highlights
- CLINCH study – 2.4 mg/kg cohort: In patients treated with ATG-022 at 2.4 mg/kg, the objective response rate (ORR) reached 40%, with a disease control rate (DCR) of 90%. Among patients with high CLDN18.2 expression, median progression-free survival (mPFS) was 5.09 months, and median overall survival (mOS) was 14.72 months.
- CLINCH study – 1.8 mg/kg cohort: In the 1.8 mg/kg dose cohort, ATG-022 achieved an ORR of 46.7% and a DCR of 86.7%, with an mPFS of 6.97 months, further supporting the antitumor activity of ATG-022 across different dose levels.
- Beyond gastrointestinal malignancies, positive antitumor signals with ATG-022 were also observed in selected non-gastrointestinal tumor types, suggesting a broader potential clinical application for CLDN18.2-targeted therapy.
- Advancement of next-generation ADCs and TCEs: Antengene reported steady progress in its next-generation ADC and TCE pipeline and plans to submit an Investigational New Drug (IND) application for ATG-125 in Q1 2027, followed by IND submissions for ATG-106 and ATG-110 in the first half of 2027.
Sunshine Lake’s (6887.HK) SGLT2 Inhibitor Olorigliflozin Wins NMPA Approval for Type 2 Diabetes
Key Words: olorigliflozin, Dongzean, SGLT2 inhibitor, hypoglycemic agent, type 2 diabetes mellitus, T2DM, NMPA
The News: Sunshine announced that its independently developed Class 1 innovative hypoglycemic drug, olorigliflozin (trade name: Dongzean), has been approved for marketing by China’s National Medical Products Administration (NMPA). Olorigliflozin, an SGLT2 inhibitor, is indicated as monotherapy or in combination with metformin to improve glycemic control in adult patients with type 2 diabetes mellitus (T2DM). The approval is supported by two multicenter, randomized, double-blind, placebo-controlled Phase III clinical studies demonstrating significant and durable glucose-lowering efficacy along with additional metabolic benefits.
Key Highlights
- Olorigliflozin (Dongzean) is approved as monotherapy or in combination with metformin for improving glycemic control in adult patients with T2DM.
- Pivotal Phase III studies: The NMPA approval is based on two multicenter, randomized, double-blind, placebo-controlled Phase III clinical trials in patients with T2DM, evaluating the efficacy and safety of olorigliflozin over a 24-week treatment period.
- Glycemic efficacy: After 24 weeks of treatment, olorigliflozin significantly reduced HbA1c levels from baseline. Patients also showed sustained improvements in fasting blood glucose (FBG) and 2-hour postprandial glucose (2h-PPG).
- Compared with similar SGLT2 inhibitors, olorigliflozin achieved a significantly higher HbA1c target attainment rate (HbA1c <7%), highlighting its competitive glycemic control profile.
- Beyond glucose lowering, olorigliflozin demonstrated additional metabolic benefits, including reductions in body weight and improvements in blood pressure, underscoring its potential to address multiple cardiometabolic risk factors in T2DM patients.
Kailera Therapeutics Announces First Participants Randomized in KaiNETIC Global Phase 3 Clinical Program of GLP-1/GIP Receptor Dual Agonist Ribupatide (KAI-9531)
Key Words: Ribupatide (KAI-9531), GLP-1/GIP receptor dual agonist, obesity care, KaiNETIC Phase 3 program
The News: On January 12, 2026, Kailera announced the randomization of the first participants in its KaiNETIC global Phase 3 clinical program. The program aims to evaluate ribupatide (KAI-9531), a once-weekly injectable GLP-1/GIP receptor dual agonist, for the treatment of people living with obesity or overweight. This milestone marks an important step in Kailera’s efforts to advance next-generation obesity therapies globally.
Key Highlights:
- KaiNETIC Phase 3 Program:
- The program includes three global, double-blind, placebo-controlled trials (KaiNETIC-1, 2, and 3), targeting diverse patient populations with obesity or overweight.
- Participants will receive weekly ribupatide doses of up to 10 mg over 76 weeks, with endpoints including percentage weight loss and metabolic improvements.
- Clinical Data: Previous trials demonstrated ribupatide’s potential to reduce body weight by 23.6% after 36 weeks (8 mg dose), compared to 1.8% with placebo, with a favorable safety profile.
- Pipeline Expansion: Kailera is also advancing other obesity-focused assets, including an oral GLP-1 receptor agonist (KAI-7535) and a GLP-1/GIP/glucagon receptor tri-agonist (KAI-4729), to provide more treatment options for patients at different stages of their journey.
Prepared by the Selesta Research Team.
research@selesta.ai
Selesta is a healthcare and life science advisory firm dedicated to serving Asia’s emerging entrepreneurs and businesses.
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