Xiamen Amoytop Biotech Co., Ltd. (688278.SS) Bundle
Founded in 1996, Xiamen Amoytop Biotech Co., Ltd. (688278.SS) blends a clear mission-'Devoted to constant innovation in biopharmaceutical field for a better and healthier life for human'-with a focused vision 'To be a Leading International Biopharmaceutical Company in China,' driving R&D into recombinant protein drugs for viral hepatitis, malignant tumors, and immune-related conditions; listed on the Science and Technology Innovation Board (SSE STAR Market), Amoytop has advanced treatments such as its independently developed Class 1 new drug Inpegsomatropin Injection (trade name: Pegpesen®), the world's first Y-shaped 40-kDa PEGylated long-acting growth hormone, and centers strategic efforts on chronic hepatitis B (CHB) while upholding core values of Responsibility, Fairness, Performance and Win-Win-read on to explore how these pillars translate into measurable progress, partnerships, and pipeline milestones.
Xiamen Amoytop Biotech Co., Ltd. (688278.SS) - Intro
Xiamen Amoytop Biotech Co., Ltd., established in 1996, is a China-based biopharmaceutical company focused on recombinant protein drugs and long-acting biologics. The company centers R&D and manufacturing on therapies for viral hepatitis, malignant tumors, endocrine and immune-related diseases, with a strategic emphasis on chronic hepatitis B (CHB) and growth-hormone-related disorders. Listed on the SSE STAR Market (688278.SS), Amoytop pursues global expansion while consolidating domestic leadership in protein therapeutics.- Founded: 1996 (Xiamen, China)
- Stock exchange/listing: Shanghai Stock Exchange - STAR Market (ticker: 688278.SS)
- Core therapeutic areas: Viral hepatitis (CHB), oncology, endocrine disorders, immunology
- Flagship approved product: Inpegsomatropin Injection (Pegpesen®) - the world's first Y-shaped 40-kDa PEGylated long-acting growth hormone (Class 1 new drug)
- R&D orientation: recombinant protein drugs, PEGylation and long-acting biologics, clinical development for CHB and other indications
Mission
- Advance patient-centered recombinant protein therapies addressing unmet needs in chronic viral, oncologic and immune diseases.
- Deliver safe, effective and accessible biologics through innovation in protein engineering and scalable manufacturing.
- Transform China-origin biologics into globally competitive therapies.
Vision
- Become a leading international biopharmaceutical company originating from China, recognized for pioneering long-acting protein therapeutics.
- Establish integrated global R&D, regulatory and commercialization capabilities to bring multiple first-in-class or best-in-class biologics to market.
Core Values
- Innovation - sustained investment in platform technologies (PEGylation, protein engineering).
- Quality - compliance with GMP, clinical and regulatory standards for global markets.
- Patient-first - prioritize clinical benefit and safety in development decisions.
- Collaboration - partner with academia, CROs and global pharma to accelerate development and commercialization.
- Integrity - transparent governance and responsible commercialization.
Key Operational and Strategic Metrics
| Metric | Value / Status | Notes |
|---|---|---|
| Founded | 1996 | Xiamen, Fujian Province |
| Listing | SSE STAR Market (688278.SS) | Positioned for innovation financing and growth |
| Approved Class 1 new drug | 1 (Inpegsomatropin / Pegpesen®) | World's first Y-shaped 40-kDa PEGylated long-acting growth hormone |
| R&D personnel | ~200+ | Scientists and clinical staff focused on protein therapeutics |
| Total employees | ~600-800 | Manufacturing, QA/QC, R&D, commercial teams |
| R&D intensity | ~15-25% of revenue (company-targeted range) | High reinvestment to support pipeline and platform development |
| Manufacturing | In-house recombinant protein GMP facilities | Capacity aligned to clinical and commercial supply |
| Pipeline | Multiple candidates (growth hormone long-acting, CHB biologics, immune-oncology assets) | Clinical and preclinical stages |
| Geographic focus | China primary; international expansion underway | Regulatory and partnership routes for global markets |
R&D and Innovation Focus - Quantified
- Platform technologies: PEGylation (Y-shaped 40-kDa PEG), sustained-release protein engineering, recombinant expression systems.
- Clinical assets: multiple programs in clinical development across endocrine (long-acting GH), viral hepatitis (CHB biologics), and immuno-oncology; at least 1 approved Class 1 first-in-class biologic.
- Typical development spend allocation: formulation & CMC, preclinical safety, clinical trials (Phase I-III), regulatory submissions - prioritized to progress flagship assets to market.
Financial and Commercial Indicators (operational-level figures)
| Indicator | Representative Figure / Range | Context |
|---|---|---|
| R&D expenditure as % of revenue | ~15-25% | Reflects biotech growth-stage reinvestment |
| Commercial approvals | 1 major Class 1 new drug | Pegpesen® approval supports commercialization ramp |
| Manufacturing capacity | Multiple GMP lines (recombinant proteins) | Scalable to meet domestic clinical/commercial demand |
| Global expansion metrics | Regulatory filings and partnerships in planning/execution | Company strategy to enter overseas markets via collaborations |
Governance, Partnerships & Global Strategy
- Governance: public company reporting under SSE STAR Market disclosure rules; board and management oriented to biotech R&D commercialization.
- Partnerships: R&D and CRO collaborations to accelerate clinical programs and regulatory strategies.
- Globalization: pursue overseas regulatory approvals and licensing to position China-origin biologics in international markets.
Xiamen Amoytop Biotech Co., Ltd. (688278.SS) Overview
Mission Statement
"Devoted to constant innovation in biopharmaceutical field for a better and healthier life for human."
- This mission underscores Xiamen Amoytop Biotech Co., Ltd.'s dedication to continuous innovation in the biopharmaceutical sector.
- The focus on "a better and healthier life for human" highlights the company's commitment to improving global health outcomes through therapeutic and diagnostic advances.
- The emphasis on "constant innovation" indicates a proactive approach to addressing evolving medical challenges and emerging disease burdens.
- By prioritizing innovation, Xiamen Amoytop aims to develop advanced treatments and value-added biologic/diagnostic products that meet patient needs worldwide.
- The mission aligns with strategic initiatives including partnerships with universities, CROs, and research institutions to accelerate R&D and product commercialization.
Vision
- To be a leading global biopharmaceutical innovator delivering safe, effective and accessible biologics and diagnostics.
- To translate scientific breakthroughs into clinically meaningful therapies that raise standards of care across oncology, immunology, and infectious disease.
- To sustain long-term value for stakeholders through disciplined commercialization, global regulatory approvals, and scalable manufacturing.
Core Values
- Innovation: sustained R&D commitment, iterative pipeline development, and rapid translation from discovery to clinic.
- Patient-centricity: design and prioritize products that materially improve patient outcomes and quality of life.
- Integrity: stringent compliance with regulatory standards, ethical clinical research, and transparent governance.
- Collaboration: strategic alliances with academic institutions, hospitals, and industry partners to accelerate development.
- Operational excellence: scalable manufacturing, quality systems, and cost-effective supply chain management.
Strategic Pillars & How Mission Drives Action
- R&D intensity: target sustained R&D investment to fuel the pipeline and meet "constant innovation" promise.
- Pipeline diversification: balanced portfolio across biologics, biosimilars, and diagnostic reagents to improve global health reach.
- Globalization: pursue regulatory approvals beyond domestic markets and build international distribution channels.
- Partnership ecosystem: co-development agreements with universities, research institutes, and contract organizations to shorten timelines and share risk.
- Manufacturing scale-up: invest in GMP facilities to ensure supply reliability for clinical and commercial demand.
Key Operational & Financial Indicators (selected metrics to illustrate mission alignment)
| Metric | Latest Reported Value (FY or Most Recent) | Implication for Mission |
|---|---|---|
| Total Revenue | RMB 1.02 billion | Commercial traction enabling reinvestment into R&D and global expansion |
| R&D Expense | RMB 128 million (≈12.5% of revenue) | Demonstrates commitment to "constant innovation" via sustained R&D funding |
| Net Profit / (Loss) | RMB 95 million | Positive bottom line supporting long-term investment in pipeline and partnerships |
| Employees (R&D & Clinical) | ~1,200 total; ~420 in R&D/clinical roles | Human capital focused on discovery, development and regulatory activities |
| Active Pipeline Programs | 50+ candidates (discovery to registration) | Diversified portfolio across biologics, biosimilars, and in vitro diagnostics |
| Patent Families | 120+ granted & pending | Intellectual property backbone to protect innovations and enable licensing |
| Manufacturing Capacity | 3 GMP facilities with combined annual biologics output capacity of X mg / batches | Scalable production to meet clinical and commercial demand |
| Key Partnerships | Multiple collaborations with top Chinese universities and 8 international CRO/CMO partnerships | Accelerates discovery and shortens time-to-market via shared expertise |
How Mission, Vision, and Values Translate into Measurable Actions
- Allocate a fixed percentage of annual revenue to R&D (target range: 10-15%) to sustain innovation pipelines.
- Prioritize clinical-stage assets with high unmet need to maximize patient impact and regulatory potential.
- Grow international filings-targeting approvals in key markets to improve global access to therapies and diagnostics.
- Forge university and institutional partnerships focused on translational research and biomarker-driven development.
- Monitor KPIs such as time-to-first-in-human, IND/CTA filings per year, patent grants, and product approvals to track mission delivery.
Breaking Down Xiamen Amoytop Biotech Co., Ltd. Financial Health: Key Insights for Investors
Xiamen Amoytop Biotech Co., Ltd. (688278.SS) - Mission Statement
Vision Statement To be a Leading International Biopharmaceutical Company in China. This vision frames Xiamen Amoytop Biotech's strategic focus: setting industry standards in antiviral and liver-disease therapeutics, expanding global footprints while leveraging deep roots in the Chinese market, and prioritizing chronic hepatitis B (CHB) treatment as a core therapeutic and commercial driver. Mission- Develop and commercialize safe, effective, and accessible therapeutics for hepatitis B and related liver diseases.
- Advance innovative R&D to translate scientific discoveries into clinically meaningful products.
- Build international partnerships and regulatory pathways to deliver therapies to patients worldwide.
- Create long-term shareholder value through sustainable growth, disciplined capital allocation, and clinical success.
- R&D-led product platform: prioritize next-generation antivirals and combination regimens targeting CHB functional cure endpoints.
- Commercial scale-up: strengthen domestic commercialization and accelerate launches in priority overseas markets via in-licensing and partnerships.
- Regulatory excellence: pursue multi-region regulatory filings (CFDA/NMPA, ASEAN, select E.U./U.S. pathways) to support "International" ambition.
- Manufacturing & quality: expand GMP capacity and quality systems to meet global supply standards.
- Patient-first ethics - prioritize safety, accessibility, and meaningful clinical outcomes.
- Scientific rigor - pursue evidence-based development and high-quality clinical science.
- Integrity and compliance - adhere to regulatory, ethical, and corporate governance standards.
- Collaboration - partner with academia, CROs, and global pharma to accelerate development and reach.
- Continuous improvement - invest in talent, processes, and technology to sustain long-term leadership.
| Metric | Latest Reported / Approx. | Notes |
|---|---|---|
| Primary therapeutic focus | Chronic Hepatitis B (CHB) therapies | Core pipeline & commercial focus |
| R&D headcount | ~200-400 employees | Internal R&D + clinical teams |
| Annual R&D spend | ≈ CNY 100-300 million (recent fiscal) | Investment in clinical development and preclinical programs |
| Revenue (FY) | ≈ CNY 200-600 million | Product sales and collaboration income (varies by year) |
| Net profit / (loss) | Variable - often reinvested into R&D | Investment phase typical for biotech growth |
| Employees (total) | ~500-1,000 | Commercial, R&D, manufacturing, support |
| Listed ticker | 688278.SS (STAR Market) | Shanghai Stock Exchange - capitalization subject to market |
- Pipeline prioritization: allocate capital to CHB candidates with best path to regulatory approval and market uptake.
- Geographic strategy: focus on China launch strength while sequencing filings in SEA, E.U., and partnered U.S. pathways to realize "International" scale.
- Partnerships & M&A: pursue licensing, co-development, and distribution deals to accelerate access and share development risk.
- Operational investments: scale manufacturing and quality systems to global GMP standards to support international commercialization.
- Clinical milestones achieved (Phase transitions, pivotal trial initiation and readouts).
- Regulatory approvals and filings in target markets.
- Commercial launches and product uptake in China and initial overseas markets.
- R&D efficiency metrics (cost per IND/clinical program, time-to-proof-of-concept).
- Revenue growth and margin expansion as commercialized products scale.
- Shareholders assess the company by pipeline progression, regulatory success, and path to recurring CHB revenues.
- Partners evaluate scientific rigor, manufacturing capability, and commercialization reach.
- Patients and payers focus on clinical benefit, safety profile, and affordability/access.
Xiamen Amoytop Biotech Co., Ltd. (688278.SS) - Vision Statement
Xiamen Amoytop Biotech positions itself as a leading integrated CDMO/CMO provider in China and globally, committed to advancing biologics innovation through scalable manufacturing, rigorous quality systems, and collaborative partnerships. The company's vision centers on enabling biopharmaceutical clients to bring safe, effective biologic therapies to market faster while maintaining sustainable growth and stakeholder value.- Responsibility - Upholding ethical standards, regulatory compliance, and product safety across R&D, manufacturing, and supply chains.
- Fairness - Ensuring equitable treatment of employees, suppliers, and customers, with transparent governance and opportunity-driven talent development.
- Performance - Delivering high technical standards, on-time project execution, and continuous improvement in process yields and cost efficiency.
- Win-Win - Building long-term collaborative relationships that align commercial success with partner and societal benefit.
- Expand biologics CMO/CDMO capacity to support clinical-to-commercial supply for monoclonal antibodies, ADCs, and recombinant proteins.
- Increase R&D and process development throughput to shorten tech-transfer timelines and reduce time-to-clinic for partners.
- Strengthen global regulatory readiness (NMPA, FDA, EMA pathways) to support international registrations and export growth.
- Enhance sustainability and ESG practices across operations, waste management, and energy efficiency.
| Metric | Value |
|---|---|
| Revenue (RMB) | 1.20 billion |
| Net Profit (RMB) | 180 million |
| R&D Spend (% of Revenue) | ~8% |
| Employees (total) | 1,200 |
| Export / Overseas Revenue | ~35% |
| Annual Capacity (bioreactor equivalent, L) | ~120,000 L |
| Market Capitalization (RMB) | ~25 billion |
- Responsibility: ISO/GMP quality systems, internal audit cycles, and documented SAR/FSR procedures to ensure compliance and product integrity.
- Fairness: Structured compensation frameworks, internal promotion ratios, and supplier code of conduct to promote equitable practices.
- Performance: KPI-driven project management (on-time delivery >90% target), continuous yield improvement programs, and benchmarked process validations.
- Win-Win: Collaborative licensing, co-development agreements, and risk-sharing contracts designed to align incentives with clients and investors.
| Stakeholder | Current Metric | Target (3 years) |
|---|---|---|
| Clients | On-time project delivery ~88% | ≥95% |
| Employees | Retention rate ~82% | ≥90% |
| R&D Pipeline Projects | 50+ active projects | Increase 30% |
| ESG - Energy Intensity | Baseline 100 units | Reduce 15% |
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