Overall H1 Development Overview

Time moves forward and so does our effort.

In H1 2026, Nanjing Zhihe upheld its mission of "clinical-demand oriented, innovation-first, customer-centered."

While delivering generic-drug R&D services, it simultaneously advanced proprietary pipelines and innovative-drug layout.

It achieved a strong mid-year scorecard on both approvals and filing dimensions.

27 Specifications Approved

In H1 2026, Zhihe helped partners and its own projects secure approvals for 27 specifications across 20 projects.

R&D delivery efficiency and project quality continued at high levels.

(1) Helping Partner Projects Win Approval

Assisted partners in approving products including ioversol injection, polyvinyl alcohol eye drops, and compound potassium phosphate injection.

(2) Proprietary Pipeline in Concentrated Harvest Period

The proprietary pipeline saw a concentrated harvest: ebastine oral solution, magnesium sulfate sodium potassium concentrated oral solution, terlipressin for injection, tobramycin eye drops and other self-developed products obtained marketing authorization.

These launches further improved the proprietary product network and enriched the commercial product matrix.

This is an important pillar for Zhihe's deepening "R&D services + proprietary products" twin-engine strategy and lays a solid foundation for long-term core competitiveness.

(3) Innovation R&D Achieves Key Breakthrough

The innovation R&D track achieved a key breakthrough; the generic-plus-innovation strategy delivered results.

An antiviral Category 1 chemical drug formulation that the company successfully out-licensed obtained clinical-trial implied permission.

This project is a milestone in Zhihe's upgrade from pure generic-drug work to a "generic-plus-innovation" strategy.

It validates the company's ability to leap from generic development to source innovation, and lays a foundation for client cooperation and out-licensing of dozens of existing PPC molecules.

21 Filing Acceptances Obtained

The filing side also maintained an efficient pace.

In H1 2026, Zhihe and its partners received 21 drug registration filing acceptances.

These span anti-infection, cardiovascular, ophthalmology, and gastroenterology core therapeutic areas, and cover injections, oral, and ophthalmic dosage forms.

This fully demonstrates the company's multi-area, multi-form R&D service capability.

(1) Key Accepted Filings

Accepted filings include erythromycin lactobionate for injection, diphenhydramine hydrochloride injection, aztreonam-avibactam sodium for injection, and candesartan cilexetil-hydrochlorothiazide tablets.

(2) Manufacturing Site Inspection Passed

Additionally, in May 2026, one of the company's projects passed the on-site drug-development inspection.

R&D compliance and quality management systems were once again validated by authorities.

R&D Strength and Future Outlook

Behind the impressive results is Zhihe's long-term deep cultivation in pharmaceutical R&D.

(1) Full-Chain R&D Service Capability

The company has full-chain development capability for both generics and innovative drugs across API, peptide, oral solid, injection, topical, inhaled, and ophthalmic dosage forms.

It provides one-stop services including corporate development planning, product portfolio assessment and pipeline planning, pharmaceutical research, nonclinical study design, clinical research, and regulatory filing.

(2) H2 Development Plan

Steady progress, then greater achievement.

In H2 2026, Zhihe will stay true to its R&D roots, on one hand continuously refining one-stop CRO services to create more value for industry partners.

On the other hand, it will deepen the "generic-plus-innovation" strategy and accelerate proprietary pipelines and innovative-drug R&D.

Empowering client transformation with professional strength, working with partners for a brighter future.

About Zhihe

Nanjing Zhihe Pharmaceutical Technology Co., Ltd., established in 2018 in Nanjing Gulou District, is a CXO company founded by leading industry experts, providing professional drug R&D technical services.

Guided by clinical demand, innovation, and customer needs, the company provides high-quality one-stop services including corporate strategy and market-cap management, product portfolio assessment and pipeline planning, pharmaceutical research, nonclinical study design and project management, clinical research, and regulatory filing.

Through high-quality, efficient, cost-effective R&D services, the company helps clients seize opportunities in consistency evaluation, MAH policy, and centralized procurement.

Empowering enterprise growth, partners have all achieved rapid high-quality development.

In recent years, the company has strengthened CXO capacity in Beijing, Heze (Shandong), and Shijiazhuang (Hebei).

"Beijing Zhihe Aikang," "Shandong Ruzhi Biotech," and "Shijiazhuang Dishikaiwei" were established.

These subsidiaries aim to provide closer, high-quality services and create synergy with Nanjing Zhihe.

The TCM Research Institute, Improved Innovation Research Institute, and Peptide Innovation Institute strengthen Zhihe's CRO growth.

It is also a professional CMO/CDMO base with nearly 12 production lines, including vial lyophilization/aqueous injection, BFS aqueous injection/inhalation solution, BFS eye drops, hormonal nebulized inhalation, antitumor liposome, antitumor BFS aqueous injection, prefilled syringe, and oral solution/syrup.

The company owns more than 160 sets of HPLC, LC-MS, and other precision instruments from Agilent, Shimadzu, and Thermo Fisher.

It has full formulation R&D equipment for APIs, peptides, tablets, injections, topical, inhaled, and ophthalmic preparations.

The company has full-chain drug-development capability across multiple dosage forms, from preclinical PCC, API, formulation CMC, to clinical services.

The company has established multiple municipal R&D platforms, including the Nanjing Engineering Technology Research Center.

It holds honors including ISO 9001, Jiangsu Sci-Tech SME, Jiangsu Three-Star Cloud Enterprise, Jiangsu Private Sci-Tech Enterprise, Jiangsu Entrepreneurship Competition Excellent Enterprise, Nanjing Innovative SME, National High-Tech Enterprise, Jiangsu Specialized and Sophisticated SME, and National Specialized and Sophisticated "Little Giant."