Hybio Pharmaceutical

What Hybio Pharmaceutical does

Shenzhen Hybio Pharmaceutical (SZSE: 300199), founded in 1998 and listed on the Shenzhen ChiNext Board in 2011, is a vertically integrated peptide drug company that discovers, develops, manufactures, and commercializes peptide active pharmaceutical ingredients, finished dosage formulations, and CRDMO services. Its 501-1,000 person organization operates four GMP-certified production bases across Shenzhen (Pingshan for injectables), Wuhan (peptide and oligonucleotide APIs and oral solids), Gansu Tianshui (pharmaceutical intermediates and medical devices, acquired 2015), and Dali (natural extracts), with annual peptide API capacity of 1,500 kg expanding toward 5,000-10,000 kg. The company holds nearly 500 patents, and its facilities have passed US FDA, EU EMA, Brazil ANVISA, South Korea KFDA, Australia TGA, Pakistan MOH, and Indonesia BPOM inspections, with the Wuhan API site and Longhua R&D lab both receiving FDA zero-defect conclusions in late 2024 and December 2025 respectively.

Hybio's product portfolio spans 40+ peptide APIs (including semaglutide, liraglutide, tirzepatide, degarelix, glatiramer, oxytocin, desmopressin, cetrorelix) and proprietary finished formulations targeting diabetes and weight management (GLP-1), reproductive health, multiple sclerosis, oncology, and cardiovascular indications. The company generated revenue across four streams: finished formulation sales (domestic and 90+ international markets), API sales to 20+ countries, third-party CRDMO services for mg-to-10-ton GMP production, and licensing/royalty income from regional commercialization partners including Torrent Pharma (US), MCG Pharma (Turkey), Vitamedic Health (Brazil), Hikma (global), and Dr. Reddy's. In 2024 it became the first company to receive US FDA approval of a generic liraglutide ANDA, and in February 2026 its self-developed glatiramer acetate injection received FDA approval for multiple sclerosis, targeting a USD 1.377 billion 2024 global market.

Hybio operates an enterprise B2B go-to-market combining direct export sales teams (international and domestic), CRDMO business development, and regional licensing partners, with quote-based B2B pricing that is not publicly disclosed. Recent strategic moves include a September 2025 strategic cooperation agreement with Huawei Cloud to develop an AI-powered peptide process optimization assistant using NLP large models trained on the company's 100,000+ historical process development records, a July 2025 strategic investment in Carbon Cloud Peptide to co-develop GLP-1 triple agonist candidates via AI peptide chip technology, and licensing deals covering the US, Turkey, Brazil, and global peptide markets. Q1 2025 revenue reached RMB 290-310 million (93%-106% YoY growth) with a return to net profitability, signaling the inflection point of an international scale-up driven by FDA approvals, AI-enabled R&D productivity, and capacity expansion.

Name

Hybio Pharmaceutical

Legal name

深圳翰宇药业股份有限公司

Website

https://hybio.com.cn

Company type

Public

Founded year

1998

Operating status

Operating

Headcount range

501–1,000 employees

Short description

Hybio Pharmaceutical is a Shenzhen-based, vertically integrated peptide drug company founded in 1998, developing and manufacturing peptide APIs, finished formulations, and CRDMO services for global generic and innovative pharmaceutical companies across 90+ countries.

Ownership category

akta.pro rank

Product category

Peptide Pharmaceuticals

NAICS

Pharmaceutical Preparation Manufacturing (325412), Pharmaceutical and Medicine Manufacturing (3254), Medicinal and Botanical Manufacturing (325411)

SIC

Pharmaceutical Preparations (2834), Medicinal Chemicals & Botanical Products (2833)

akta.pro primary industry

Generic ANDA/Regulatory Affairs & Submissions (HLAIABAJ)

Keywords

• Peptide drug manufacturing
• Peptide API supply
• CRDMO services
• Peptide formulations
• GLP-1 therapeutics

Headquarters

HQ city

Shenzhen

HQ country

China

HQ region

Asia

Offices6 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Supply Chain, Infrastructure, Personnel, Marketing or Sales, Operations

Revenue model

1. Finished Dosage Formulations (制剂): Sales of proprietary peptide pharmaceutical products including injections, pre-filled syringes, and other dosage forms. Products include liraglutide injection, semaglutide injection, glatiramer acetate injection, and other peptide drugs. Revenue generated from domestic China and international markets including the US, Europe, and 30+ other countries.
2. Active Pharmaceutical Ingredients (原料药): Production and sales of peptide APIs to global generic pharmaceutical companies. APIs include semaglutide, liraglutide, tirzepatide, degarelix, glatiramer, oxytocin, desmopressin, cetrorelix, and 40+ other peptide APIs. Supplies to 20+ countries.
3. CRDMO Services (Contract Research, Development and Manufacturing Organization): Comprehensive one-stop services for innovative drug companies including peptide API development and manufacturing from mg to 10-ton GMP scale, formulation development, quality research, and international regulatory support. Services include custom synthesis, process development, and commercial-scale production.
4. Licensing and Technology Transfer: Revenue from licensing proprietary products to international partners for commercialization in specific territories. Examples include licensing agreements with Torrent Pharma, MCG Pharma, Vitamedic Health, and Dr. Reddy's for various peptide products.

Go-to-market motion2 records

Distribution channels4 records

Marketing channels3 records

Core offering

Hybio Pharmaceutical is a high-tech pharmaceutical company focused on the research, development, manufacturing, and commercialization of peptide-based drugs. The company produces peptide active pharmaceutical ingredients (APIs) supplied to global generic drug manufacturers, finished dosage formulations (injections, pre-filled syringes, lyophilized powder, nasal sprays) for therapeutic areas including diabetes, weight management, multiple sclerosis, reproductive health, and oncology, and offers CRDMO (Contract Research, Development, and Manufacturing Organization) services to innovative drug companies worldwide.

Differentiator

Problem solved

Functional benefit

Brands

• 翰仁: Brand for cetrorelix acetate injection product.
• 翰真
• 翰贝
• 翰宝
• 翰固
• 翰康
• 翰唯
• 翰源

Products and services

• Liraglutide Injection (利拉鲁肽注射液)
• Glatiramer Acetate Injection (醋酸格拉替雷注射液)
• Semaglutide API (司美格鲁肽原料药)
• Tirzepatide API (替尔泊肽原料药)
• Lanreotide Acetate Sustained-Release Injection (Prefilled) (醋酸兰瑞肽缓释注射液(预充式))
• CRDMO Services (Contract Research, Development and Manufacturing Organization)

Quantifiable outcome

• Process development cycle reduced by 50%+ (example: 5-step API process development from 18 months to 8.2 months)
• +4 more outcomes

Named customers8 records

Segments3 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability6 records

Feature8 records

Partnerships

14 partnerships are on record, tiered supporting, core, major and exploratory.

• Shanghai Zhengfan Technology (上海正帆科技)supportingTechnology or Integration · 25 April 2026Cooperation on organic waste liquid resource treatment and reduction in peptide production. Introduction of advanced waste liquid treatment and solvent recovery systems for peptide synthesis, cleavage, and purification processes.
• MCG PharmacoreChannel Partner/ Reseller/ Distributor · 10 April 2026Exclusive commercialization rights for liraglutide and semaglutide injection products in Turkey. Full cooperation in product registration, market access, local promotion, and follow-up services.
• Vitamedic HealthmajorChannel Partner/ Reseller/ Distributor · 7 January 2026Licensing agreement for semaglutide injection for Brazilian pharmaceutical market. Partnership to expand into Brazil's growing GLP-1 market.
• Dr. Reddy's LaboratoriescoreChannel Partner/ Reseller/ Distributor · 25 December 2025Non-binding terms sheet for strategic cooperation in peptide API and related formulations. Global peptide cooperation covering multiple markets.
• Huawei Cloud (华为云)coreTechnology or Integration · 18 September 2025Comprehensive cooperation agreement focusing on AI-powered pharmaceutical applications. Jointly developed peptide AI process optimization assistant using NLP large models, leveraging Huawei's cloud infrastructure and Hybio's 100,000+ historical process development records. Significantly improves R&D efficiency and reduces process development cycles.
• China Academy of Sciences Process Engineering Research Institute (中科院过程工程研究所)coreStrategic or Co-development Partner · 20 August 2025Strategic cooperation to establish 'Peptide High-End Sustained-Release Formulation Industry Transformation Innovation Consortium'. Focus on sustained-release microsphere technology for GLP-1 triple agonist weight loss peptides and peptide self-assembly technology applications.
• Sansure (三生蔓迪)majorChannel Partner/ Reseller/ Distributor · 19 August 2025Series of commercialization agreements for semaglutide injection (weight loss indication). Commissioned production, supply agreement, and quality agreements signed.
• BoRui Pharmaceuticals (博瑞医药)majorChannel Partner/ Reseller/ Distributor · 7 August 2025Strategic cooperation for overseas supply chain of innovative drugs. BoRui's innovative drug overseas commercialization with Hybio providing peptide API supply.
• KuCoinexploratoryOthers · 4 August 2025Strategic cooperation意向书 to explore China's first RWA (Real World Asset) tokenization pilot project for innovative drug R&D future revenue rights in Hong Kong.
• Carbon Cloud Peptide (碳云智肽)coreStrategic or Co-development Partner · 1 July 2025Strategic investment of RMB 10 million plus CRDMO service agreement. Joint development of GLP-1R/GIPR/GCGR triple agonist peptide innovative drugs using AI-powered peptide chip technology. Hybio holds strategic equity stake in Carbon Cloud Peptide.
• Yihua (怡和嘉业)supportingStrategic or Co-development Partner · 12 May 2025Strategic cooperation in sleep health management. Three-party cooperation between Hybio, Hybio Health, and Yihua covering scenario applications, technology collaboration, R&D cooperation, market collaboration and user reach.
• China National Pharmaceutical Group (国药股份)majorStrategic or Co-development Partner · 29 April 2025Strategic cooperation covering CBD innovative drug R&D, peptide and oligonucleotide drug technology integration, and commercialization promotion. Also includes cooperation with Hanyu Dali subsidiary.
• Torrent PharmacoreChannel Partner/ Reseller/ Distributor · 20 April 2025Second collaboration after abaloparatide injection partnership. Exclusive development, manufacturing and commercialization agreement for acetic acid lanreotide sustained-release injection (prefilled) in US market. Torrent handles US market commercialization while Hybio provides technical development and production.
• Hikma PharmaceuticalscoreChannel Partner/ Reseller/ Distributor · 1 January 2025Global partner for peptide products. CEO Riad Mishlawi led team visit in April 2025 to review strategic cooperation achievements and explore future collaboration directions.

Scale indicators9 records

Recent moves8 records

Expansion highlights6 records

Direct peers

• Bachem: Bachem is a leading Swiss-based peptide and oligonucleotide CDMO with global manufacturing capacity and deep expertise in complex peptide synthesis. As one of the dominant Western peptide API manufacturers serving innovator and generic pharma, Bachem is the most direct comparable to Hybio's peptide API and CRDMO business.
• AmbioPharm: AmbioPharm is a US-China based peptide CDMO specializing in custom peptide synthesis from mg to commercial scale. Their dual presence in the US and China, plus focus on complex generic peptide APIs, makes them a closely comparable peer to Hybio's peptide API and CRDMO operations.
• PolyPeptide Group: PolyPeptide Group is a specialist peptide API manufacturer headquartered in Switzerland with global manufacturing footprint. Their focus on custom peptide synthesis for pharmaceutical and cosmetic applications directly mirrors Hybio's core peptide API business model and target customer segments.
• CordenPharma: CordenPharma is a global CDMO with strong peptide manufacturing capabilities across API and finished dosage forms, including complex formulations and drug-device combinations. Their peptide platform and integrated service offering closely match Hybio's vertical integration strategy.
• Sinopep Allsino Biopharmaceutical: Sinopep is a Chinese peptide API manufacturer specializing in complex peptide synthesis including GLP-1 APIs such as semaglutide and tirzepatide. As a domestic Chinese peptide competitor pursuing international regulatory approvals, Sinopep directly competes with Hybio in the same peptide API markets.

Broad incumbents

• Asymchem Laboratories: Asymchem is a major Chinese CDMO with strong small molecule API capabilities that has been expanding into peptide and oligonucleotide manufacturing. As a fellow Chinese CRDMO with international GMP certifications, Asymchem represents both a competitor and benchmark for Hybio's international growth.
• WuXi AppTec: WuXi AppTec is a leading global CRDMO with broad capabilities across peptides, oligonucleotides, small molecules, and biologics. While not exclusively focused on peptides, WuXi competes with Hybio in peptide API and CRDMO services and represents a much larger incumbent alternative for global pharma customers.
• Novo Nordisk: Novo Nordisk is the global leader in GLP-1 peptide drugs (semaglutide/Ozempic/Wegovy, liraglutide/Victoza) and the dominant innovator whose patent expiries drive the generic peptide opportunity Hybio is pursuing. As the upstream patent holder and dominant commercial player, Novo Nordisk defines the competitive landscape for Hybio's core API and formulation business.
• Teva Pharmaceutical Industries: Teva is a global leader in generic and specialty pharmaceuticals with significant peptide and complex injectable capabilities, including the originator glatiramer acetate franchise (Copaxone). As both a potential competitor and partner for Hybio's generic peptide launches, Teva is highly relevant to Hybio's competitive positioning in the US generics market.

Regional players

• Ferring Pharmaceuticals: Ferring Pharmaceuticals is a Swiss-headquartered specialty pharma with strong peptide franchise in reproductive health and gastroenterology. As a partner and customer of Hybio (per company history), Ferring provides a benchmark for branded peptide commercialization that Hybio is increasingly pursuing with its own proprietary launches.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks6 records

Key highlights8 records

Customer concentration

• LinkedInlinkedin.com/company/hybio-pharmaceutical

Revenue estimate

Valuation estimate

Number of profiles

Profiles12 records

Subsidiaries6 records

Funding overview

Funding rounds2 records

Investors2 records

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

M&A1 record

Investments3 records

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

Frequently asked questions about Hybio Pharmaceutical