Mission Statement, Vision, & Core Values (2026) of RemeGen Co., Ltd.

RemeGen Co., Ltd. (9995.HK), founded in 2008 and headquartered in Yantai, Shandong Province, is forging a path in biopharmaceuticals by developing first-in-class and best-in-class therapies-spanning Antibody-Drug Conjugates, antibody fusion proteins, monoclonal and bispecific antibodies-to address unmet needs in oncology, autoimmune diseases and ophthalmology; the company has advanced its lead candidate RC18 (Telitacicept) into clinical trials and demonstrated its commitment to innovation with R&D spending of ¥1.56 billion in 2023, underpinned by core values of innovation, integrity, collaboration, excellence, customer-centricity and sustainability that drive its mission to create clinical value and pursue world-class leadership within China and beyond

RemeGen Co., Ltd. (9995.HK) - Intro

• Headquarters: Yantai, Shandong Province, China
• Founded: 2008
• Stock listing: Hong Kong Stock Exchange, 9995.HK (IPO 2021)
• Therapeutic focus: ADCs, antibody fusion proteins, monoclonal & bispecific antibodies
• Clinical focus areas: Autoimmune diseases, oncology, ophthalmology

• Develop transformative biologics that address high unmet medical needs with patient-centric innovation.
• Translate cutting‑edge antibody technologies into accessible therapies across China and global markets.

• Be recognized as a global pioneer in antibody therapeutics, delivering first‑ and best‑in‑class treatments that change standards of care in oncology, autoimmune disease, and ophthalmology.
• Expand a sustainable pipeline and commercial footprint that balances scientific leadership with long‑term shareholder value.

• Scientific excellence - rigorous discovery and translational science to advance novel modalities (ADCs, fusion proteins, bispecifics).
• Patient focus - prioritizing safety, access, and clinically meaningful outcomes.
• Integrity & compliance - adhering to global regulatory and ethical standards in R&D and commercialization.
• Collaboration - partnering with global research institutions, CROs, and commercial partners to accelerate development and reach.
• Continuous innovation - sustained investment in R&D (¥1.56B in 2023) to drive next‑generation candidates.

• Advance RC18 and other pipeline candidates through clinical development with clear regulatory milestones and enrolment targets for pivotal trials.
• Scale manufacturing and CMC capabilities to support commercial launches and export-align capacity planning with projected launch timelines.
• Grow global partnerships and licensing to accelerate market access and diversify revenue streams.
• Maintain disciplined capital allocation with a focus on R&D intensity and operational efficiency.

RemeGen Co., Ltd. (9995.HK) - Overview

Mission Statement

RemeGen's mission is to discover, develop, manufacture, and commercialize first-in-class and best-in-class biopharmaceuticals for autoimmune, oncological, and ophthalmological diseases, aiming to create clinical value and fulfill unmet clinical needs worldwide, thereby maximizing the company's value.

• Focus on first‑in‑class and best‑in‑class therapies to set new standards in patient care.
• Therapeutic areas targeted: oncology, autoimmune diseases, and ophthalmology - high unmet medical need segments globally.
• Patient-centric approach emphasizing measurable clinical value and improved outcomes.
• Integration of mission with commercial strategy to ensure sustainability and shareholder value.

Strategic priorities aligned with the mission

• Advance lead assets from clinical proof‑of‑concept to global commercialization.
• Invest heavily in R&D, biologics manufacturing capacity, and regulatory filings across major markets.
• Forge global partnerships and out‑licensing to accelerate access and scale.
• Maintain quality manufacturing and scalable supply chains to support worldwide launches.

Pipeline and clinical footprint (operational metrics as of 2024, approximate where noted)

How the mission translates into measurable goals and KPIs

• Clinical value: target objective response rates, survival endpoints, and patient‑reported outcomes as primary success metrics in pivotal trials.
• Regulatory milestones: completions of pivotal trials, NDA/MAA submissions in China, US, EU, and other key markets.
• Commercial reach: expand product launches from China to APAC, EU, and US via direct launches or partnerships.
• Financial health: sustainable revenue growth from product sales combined with licensing and collaboration income to maximize company value.

Organizational culture and core values supporting the mission

• Innovation: prioritizing first‑in‑class science and technological differentiation.
• Patient focus: aligning programs to unmet clinical needs and measurable patient benefit.
• Quality & compliance: maintaining high standards across R&D, manufacturing, and commercialization.
• Collaboration: partnering with academic, clinical, and commercial organizations globally.
• Sustainability: balancing mission‑driven R&D with commercial strategies to ensure long‑term growth.

Relevant resource

RemeGen Co., Ltd.: History, Ownership, Mission, How It Works & Makes Money

RemeGen Co., Ltd. (9995.HK) - Mission Statement

• Leadership focus: attain top-tier position within China's biopharma sector through differentiated oncology and immunology therapeutics.
• World‑class standards: align研发 (R&D), CMC, clinical development and quality systems with international regulatory expectations (NMPA, EMA, FDA) to enable global competitiveness.
• Domestic emphasis: leverage China's talent pool, clinical trial network and manufacturing scale to rapidly advance late‑stage programs and commercialization.
• Patient impact: prioritize indications with significant unmet need (e.g., HER2‑expressing solid tumors, urothelial carcinoma) to maximize clinical benefit and health‑economic value.

• Pipeline acceleration: progress proprietary ADCs and monoclonal antibodies through Phase I-III with robust biomarker strategies and label‑driven development plans.
• Manufacturing and supply: scale GMP biologics and fill/finish capacity to support commercial launches and global partnerships.
• Commercial execution: establish payer, hospital and oncology KOL networks to drive uptake of approved products and generate real‑world evidence.
• Partnership and licensing: pursue co‑development and out‑licensing to expand geographic reach and optimize capital efficiency.

• Science‑first integrity - decisions grounded in rigorous data, reproducibility and ethical clinical conduct.
• Patient‑centricity - accelerate development timelines where safe and justified to bring therapies to patients sooner.
• Operational excellence - disciplined project management, quality systems and cost control to convert R&D into commercial success.
• Collaboration - foster internal cross‑functional teamwork and external partnerships with academia, CROs and pharma.
• Innovation with accountability - pursue bold science while meeting regulatory, safety and financial expectations.

• Regulatory approvals and label expansions (count and timing of NMPA/foreign approvals).
• Commercial launch metrics: hospital listings, NRDL negotiations, first‑year patient starts.
• R&D productivity: INDs filed, Phase II/III initiations, pivotal trial readouts annually.
• Financial sustainability: recurrent product revenue, margins, and reinvestment rate into R&D.

RemeGen Co., Ltd. (9995.HK) - Vision Statement

• R&D commitment: Targeting annual reinvestment of 30%-40% of operating income into discovery and clinical development to accelerate first-in-class and best-in-class candidates.
• Global reach: Expand registrations and partnerships across Asia, Europe, and North America with a goal of 50% of product revenues derived from overseas markets by 2030.
• Patient impact: Strive to increase treated patient-years by an average of 25% year-over-year through scale-up of manufacturing and distribution channels.

• Innovation - Sustained investment in biologics platforms, antibody-drug conjugates (ADCs) and bispecific antibodies drives product differentiation and pipeline depth (currently comprising double-digit clinical programs spanning preclinical to late-stage).
• Integrity - Rigorous compliance, ethical clinical conduct, and transparent reporting underpin stakeholder trust; regulatory approvals and audit outcomes guide governance standards.
• Collaboration - Strategic alliances with academic centers, CROs and regional pharma partners accelerate development timelines and broaden market access.
• Excellence - Quality systems and GMP manufacturing scale support consistent product supply; target product batch-release success rates exceed 98%.
• Customer-centricity - Patient and physician feedback loops inform lifecycle management and real-world evidence programs to optimize outcomes and adherence.
• Sustainability - Operational initiatives aim to reduce emissions intensity and implement green chemistry in bioprocessing, with a roadmap to reduce energy use per unit produced by 20% over five years.

• Advance high-value clinical assets: Prioritize registration-enabling trials and accelerated pathways to capture market share in targeted oncology indications.
• Scale global commercialization: Establish regional partnerships, local regulatory filings and market access strategies to reach the 50% overseas revenue target by 2030.
• Optimize manufacturing and supply chain resilience: Invest in capacity and quality systems to sustain >98% batch-release reliability and meet growing demand.
• Embed ESG into operations: Monitor KPIs for emissions, waste and resource efficiency while maintaining compliance and ethical standards.
• Deepen stakeholder trust: Transparent reporting, patient safety tracking and adherence to global regulatory best practices.

• Clinical milestones achieved per year (e.g., INDs, pivotal trial initiations, NDA submissions): target 2-4
• Revenue mix: increase export sales to 50% of total by 2030
• R&D intensity: maintain 30%-40% reinvestment of operating income
• Manufacturing yield: maintain >98% batch-release success
• Sustainability: 20% reduction in energy per unit within 5 years