Nanjing Haiwei Pharmaceutical Technology Co.

What Nanjing Haiwei Pharmaceutical Technology Co. does

Nanjing Haiwei Pharmaceutical Technology Co. (南京海维医药科技有限公司) is a Nanjing-headquartered contract R&D services company founded in 2018 that delivers pharmaceutical formulation development and stability science to large drug developers and FMCG companies. Its core asset is the Asia-Pacific exclusive license for the ASAPprime® Stability Prediction Platform, a proprietary degradation kinetics modeling technology that combines isoconversion principles with humidity-corrected Arrhenius-based kinetic models to predict long-term drug product stability from accelerated data within 2–4 weeks — versus months of ICH stability testing. The platform has regulatory validation across 50+ INDs, 30+ NDAs, and 15+ post-approval applications in 31+ countries, and is used by 18 of the top 20 global small molecule innovative drug companies.

The company operates four integrated technology platforms: the ASAPprime® stability prediction core; a high-throughput micro-scale formulation screening platform featuring 96-channel amorphous solid dispersion (ASD) screening with under 200mg API consumption; a poorly-soluble drug formulation development platform covering ASDs, nanocrystals, and self-emulsifying systems; and a solid-phase chemistry R&D platform for crystal form, salt, and co-crystal screening using XRD, DSC, TGA, DVS, and 96-channel slow evaporation. Equipment extends to GMP-like 3kg ASD production via spray dryer, hot-melt extruder, and tablet press, sufficient for IND batch requirements.

The company generates revenue through project-based fee-for-service engagements covering drug stability prediction, formulation design and process development, quality research and analytical development, and solid-phase chemistry research. The named customer base spans domestic Chinese pharmaceutical majors (Hengrui, Hansoh, BeiGene, Simcere, Chia Tai Tianqing, Beta, Grandpharm), global pharmaceutical (J&J), and FMCG multinationals (P&G, Kalbe, SK Chemical). The firm was co-founded by senior pharmaceutical scientists including former Janssen Belgium and Hengrui R&D leadership, is privately held with no disclosed funding rounds, and operates with a 11–50 employee headcount from its Nanjing facility in Qixia District.

Name

Nanjing Haiwei Pharmaceutical Technology Co.

Legal name

南京海维医药科技有限公司

Website

https://haiwei-tech.com

Company type

Private

Founded year

2018

Operating status

Operating

Headcount range

11–50 employees

Short description

Nanjing Haiwei Pharmaceutical Technology Co. is a Nanjing-based contract R&D firm providing drug stability prediction, formulation development, and analytical services to large pharmaceutical and FMCG companies, anchored by an Asia-Pacific exclusive license for the ASAPprime® stability prediction platform.

Ownership category

akta.pro rank

Product category

Pharmaceutical Contract R&D Services

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714), Pharmaceutical Preparation Manufacturing (325412)

SIC

Services-Commercial Physical & Biological Research (8731), Services-Testing Laboratories (8734), Pharmaceutical Preparations (2834)

akta.pro primary industry

Stability Testing (ICH Programs) (HLAGADAD)

akta.pro secondary industries

CMC & Pharmaceutical Development (Formulation/Process/Analytical Development) (HLAIALAD), Solid-State Chemistry & Preformulation (Polymorph/Crystallization) (HLAGAHAI), Method Development & Validation (ICH/USP) (HLAGADAB), Small-Molecule Analytical Development & Method Validation (CMC) (HLAGAHAF), Crystallization, Particle Engineering & Micronization Services (HLAGAHAJ)

Keywords

• Drug stability prediction
• Pharmaceutical formulation development
• Analytical method development
• Amorphous solid dispersion
• Solid-phase chemistry

Headquarters

HQ city

Nanjing

HQ country

China

HQ region

Asia

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Technology or R&D

Revenue model

1. Contract R&D Services: The company provides fee-for-service pharmaceutical R&D contract services, including drug stability prediction, formulation development, quality research, and solid-phase chemistry services. Revenue is generated through project-based engagements with pharmaceutical and FMCG companies, covering new drug development, improved new drugs, and marketed products. The company has served multiple billion-yuan-scale pharmaceutical companies (恒瑞, 豪森, 远大, 百济神州) and FMCG leaders (Kalbe, P&G, SK Chemical).

Go-to-market motion1 record

Distribution channels1 record

Marketing channels4 records

Core offering

Nanjing Haiwei provides contract pharmaceutical R&D services spanning drug stability prediction, formulation design for poorly soluble drugs, quality research and analytical development, and solid-phase chemistry (crystal/salt/co-crystal screening, crystallization process development). The company is the Asia-Pacific exclusive licensee of the ASAPprime® accelerated stability assessment platform, which predicts long-term drug stability in 2–4 weeks using isoconversion-based degradation kinetics modeling, supported by high-throughput 96-channel micro-scale formulation screening, compaction simulation, and GMP-like ASD manufacturing equipment.

Product overview

Nanjing Haiwei Pharmaceutical Technology Co. is a pharmaceutical technology service company that has developed multiple integrated technology platforms. The core offering is the ASAPprime® Stability Prediction Platform, which uses proprietary accelerated stability assessment program (ASAP) technology for rapid stability prediction. Supporting platforms include the High-Throughput Micro-Scale Formulation Screening Platform (featuring 96-channel screening technologies), the Poorly Soluble Drug Formulation Development Platform (covering amorphous solid dispersions, nanocrystals, and self-emulsifying formulations), and the Solid-Phase Chemistry R&D Platform (for crystal form, salt, and co-crystal screening). The company provides comprehensive services across drug stability prediction, formulation development, quality research, and solid-phase chemistry.

Differentiator

Problem solved

Functional benefit

Brands

• ASAPprime®: Stability prediction platform using accelerated stability assessment program technology for predicting long-term stability and shelf life of pharmaceutical products
• ASAPprime® 稳定性预测平台

Products and services

• ASAPprime® Stability Prediction Platform (ASAPprime® 稳定性预测平台) Proprietary software platform for shelf-life prediction based on short-term accelerated stability data. Uses isoconversion principles and humidity-corrected Arrhenius degradation kinetics models to predict long-term product stability within 2–4 weeks, supporting impurity, assay, color, dissolution, and crystallinity predictions. Globally, 18 of the top 20 small molecule innovative drug companies use this technology; used in 50+ IND, 30+ NDA, and 15+ post-approval applications across 31+ countries.
• High-Throughput Micro-Scale Formulation Screening Platform (高通量微量化制剂筛选平台) High-throughput screening platform featuring 96-channel amorphous solid dispersion (ASD) screening technology capable of evaluating hundreds of formulations using less than 200 mg of API, plus a 96-channel Skin PAMPA parallel artificial membrane permeation assay for transdermal drug delivery evaluation. Each channel produces an independent, representative ASD thin film enabling physiologically relevant dissolution testing and physical stability assessment via polarized light microscopy.
• Poorly Soluble Drug Formulation Development Technology Platform (难溶性药物制剂开发技术平台) Full-workflow platform for poorly soluble drug formulation development, covering the full chain from prescription screening to process development and material characterization. Includes amorphous solid dispersion, nanocrystal, and self-emulsifying formulation capabilities with comprehensive amorphous material characterization.
• Solid-Phase Chemistry R&D Platform (固相化学研发平台) Solid-phase chemistry R&D platform providing crystal form screening, salt screening, co-crystal screening, crystallization process development and optimization, and amorphous material characterization using XRD, DSC, TGA, DVS, and 96-channel slow evaporation technologies, plus parallel crystallization.
• Drug Stability Prediction Service (药物稳定性预测服务) Fee-for-service degradation kinetics modeling service that accurately predicts long-term product stability in 2–4 weeks, quantifies stability risks, and enables scientific establishment of impurity limits for APIs and formulations. Supports impurity, content, color, dissolution, and crystallinity predictions. Used by 18 of the top 20 global small molecule innovative drug companies.
• Formulation Design and Process Development Service (制剂处方与工艺开发服务) Formulation design and process development service for poorly soluble drugs, covering amorphous solid dispersion design, nanocrystal suspension screening and evaluation, Skin PAMPA 96-channel transdermal formulation screening, and tablet compaction simulation using milligram-to-gram-scale API. Supports gram-level scale-up of tablet processes via compaction simulation technology.
• Quality Research and Analytical Development Service (质量研究与分析开发服务)

Quantifiable outcome

• 2–4 weeks to predict product long-term stability and shelf life (vs. months of ICH testing)
• +5 more outcomes

Named customers11 records

Segments1 record

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature7 records

Partnerships

Four partnerships are on record, tiered core.

• Koppers Group (科佩集团)coreGTM or Marketing PartnerKoppers Group (科佩集团) co-organized the 2024 Shanghai seminar and the 2025 Chengdu seminar on drug stability, excipient-compatibility, and packaging material screening alongside Nanjing Haiwei and German Mettler Toledo. The partnership focuses on joint industry education and market development in the pharmaceutical stability space.
• Mettler Toledo (德国美剂乐集团上海代表处)coreGTM or Marketing PartnerMettler Toledo's Shanghai representative office co-organized the 2024 Shanghai and 2025 Chengdu technical seminars with Nanjing Haiwei and Koppers Group. The partnership leverages Mettler Toledo's instrumentation expertise (thermal analysis, moisture analysis) in pharmaceutical stability and formulation, with joint marketing and seminar delivery to Chinese pharmaceutical companies.
• Spektra Consultation (Americas)coreStrategic or Co-development PartnerNanjing Haiwei established a strategic collaboration with Spektra Consultation (Americas) using Zeneth software for drug degradation pathway prediction and derek/sarah software for genotoxic impurity prediction. Spektra provides expert review services supporting Haiwei's quality research services for regulatory submissions.
• GEA-NUS PPRL (Singapore)coreStrategic or Co-development PartnerIn 2023, Haiwei obtained advanced pilot-scale formulation equipment from GEA-NUS PPRL (Process and Product Realization Lab at the National University of Singapore). Dr. Paul Heng, director of Haiwei and founder of GEA-NUS, facilitates technology transfer of advanced formulation equipment and processes to Haiwei's Nanjing facility.

Scale indicators7 records

Recent moves6 records

Expansion highlights6 records

Broad incumbents

• Hovione: Particle engineering and poorly-soluble drug specialist (spray drying, ASD) with global scale, overlapping Haiwei's stated particle-engineering ambition and poorly-soluble formulation platform.
• WuXi STA (STA Pharmaceutical): WuXi AppTec's small-molecule CDMO arm providing formulation, analytical and solid-form services in China, an incumbent that can bundle Haiwei's niche into broader programs.
• Quotient Sciences: Integrated formulation development and CMC services provider comparable to Haiwei's formulation/process development offering, at larger international scale.
• Catalent: Global CDMO with extensive formulation, poorly-soluble drug and stability testing capabilities, a large incumbent offering overlapping services on a broader scale.

Regional players

• Pharmaron: Large China-headquartered CRO/CDMO offering CMC, formulation and analytical services; competes for the same Chinese pharma R&D outsourcing budgets as Haiwei.
• Porton Pharma Solutions: Chinese CDMO offering API, formulation and CMC development services, competing regionally across overlapping development capabilities.

Direct peers

• Crystal Pharmatech: China-based CRO specializing in solid-state chemistry, crystal/salt/co-crystal screening, and pharmaceutical development—directly overlapping Haiwei's solid-phase chemistry and formulation services.
• Triclinic Labs: US CRO focused on solid-state characterization, polymorph/salt screening and analytical development, closely mirroring Haiwei's solid-state and analytical service lines.
• FreeThink Technologies: Founded by Ken Waterman (Haiwei advisor), FreeThink pioneered ASAP-based predictive stability services—the same methodology at the core of Haiwei's flagship offering.

Emerging players

• XtalPi: China-based firm using computational/AI models for crystal structure and solid-form prediction, intersecting Haiwei's predictive solid-state and stability modeling positioning.

Market position

Strengths5 records

Weaknesses4 records

Competitive moat5 records

Key risks5 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/nanjing-haiwei-pharmaceutical-technologies

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Nanjing Haiwei Pharmaceutical Technology Co.