Sustainable development

Environmental Criteria Management Policy for the Development of New Products and Services


Release time:

2026-09-11

LIVZON PHARMACEUTICAL GROUP INC.

Environmental Criteria Management Policy

for the Development of New Products and Services

 

Article 1 Purpose

This Policy aims to integrate environmental criteria into the full life-cycle management of new products, new services and material changes, covering project initiation, design, process development, technology transfer, production, distribution, use and discontinuation. While ensuring quality, safety, regulatory compliance and access to medicines, environmental impacts shall be assessed in parallel and reduced, so as to mitigate potential environmental compliance and liability risks and to capture opportunities in green and low-carbon products.

 

Article 2 Governance

This Policy is overseen by the Board of Directors and the ESG Committee under the Board. Relevant business units shall implement this Policy in accordance with their respective responsibilities. The ESG Committee shall report regularly to the Board on the implementation of this Policy and provide recommendations for the Board’s decision-making and supervision.

 

Article 3 General Requirements

Environmental assessment shall be conducted for new product development across five stages: selection of raw materials and components; production and manufacturing; distribution, storage and transportation; use-phase operation and servicing; and end-of-life management. Priority shall be given to reducing water use, energy use, material consumption, pollutant emissions, hazardous waste and toxic or hazardous substances. Circular economy requirements shall be embedded in design, production and waste management, promoting green procurement, efficient utilization, segregated recycling and resource recovery. Environmental assessment shall be implemented in parallel with quality risk management and shall cover all stages from development through discontinuation.

 

Article 4 Raw Materials and Components

Environmental evaluation of raw materials and components shall be completed at project initiation and at the finalization of formulation and packaging. The evaluation shall cover active ingredients, excipients, intermediates, primary packaging materials in direct contact with medicinal products, printed packaging materials and other critical components. Subject to compliance with pharmacopoeial, registration and product quality and safety requirements, preference shall be given to renewable, recyclable or biodegradable materials, and water use, energy use, material intensity and the use of hazardous and toxic substances shall be reduced. Primary packaging materials in direct contact with medicinal products shall be subject to categorized qualification and admission. For suppliers of active pharmaceutical ingredients, intermediates and materials with high environmental impact, energy intensity, process emissions, pollution-control capability and compliant hazardous-waste disposal shall be assessed, and the results shall inform supplier selection and retention. For Chinese medicinal materials and other raw materials that are climate-sensitive or subject to elevated supply risk, a dual-source arrangement combining primary and alternative production areas shall be established to reduce the risk of supply disruption and of forced substitution with higher-impact materials. Product and packaging structures shall be optimized at the design stage to reduce unnecessary material use. Where alternative materials are to be introduced or substituted, concurrent quality, regulatory and environmental verification shall be completed before incorporation into the process.

 

Article 5 Production and Manufacturing

Process development, pilot production and technology transfer for new products shall include concurrent environmental evaluation of production operations, covering exhaust gas, wastewater, solid waste, energy consumption and water consumption. Process routes shall preferentially improve yield and raw-material utilization and reduce by-products, pollutants and hazardous waste at source. Measures such as solvent recovery and reuse, waste-heat utilization, cleaner production and pollution control shall be incorporated into approved process documentation before technology transfer and shall be verified and implemented in commercial production. Commercial production shall comply with management systems for solid waste and for exhaust gas, wastewater and noise, ensuring segregated collection, standardized storage, and compliant transfer and disposal, with full traceability of hazardous waste. Resource recovery of medicinal residues, microbial residues, sludge and recoverable solvents is encouraged to reduce final disposal volumes. Production sites shall include energy intensity, water intensity, hazardous waste and general industrial solid waste associated with newly commercialized products in environmental monitoring and improvement plans, so that environmental performance is measurable and verifiable.

 

Article 6 Distribution, Storage and Transportation

Subject to product quality, storage conditions and transportation safety, packaging and logistics arrangements for new products shall be included in environmental evaluation. Packaging specifications, materials and structures shall balance protective function and material reduction, lowering packaging weight per unit of product, transport volume, damage rates and transport-related emissions. Where permitted by regulation and quality requirements, reusable transit containers shall be adopted, centrally managed and circulated, so as to reduce single-use packaging waste. Warehouse layout, temperature and humidity control and protective measures shall reduce material loss, additional energy use and waste arising from climate conditions or improper storage. Transportation shall take into account routing, load efficiency and the environmental and safety management capability of carriers. Reasonable inventory and routing arrangements shall be established for critical raw materials and finished products to reduce logistics disruption and inefficient transport. Quality and customer feedback relating to packaging, warehousing, transportation and delivery shall inform the continual improvement of packaging and logistics solutions.

 

Article 7 Use Phase

New product development shall assess resource consumption and waste generation in clinical, healthcare institution, primary-care and home-use settings. Package inserts, labelling, packaging design and accompanying administration or testing devices shall improve correct use and reduce wastage of medicinal products, repeated reconstitution, unnecessary consumables and medical waste caused by improper operation. For diagnostic reagents, medical devices and products requiring maintenance, energy, water and consumable use and durability during the use phase shall be assessed, and instructions for operation, storage and maintenance that help reduce resource consumption shall be provided. Information from medication enquiries, quality complaints, adverse events and customer satisfaction that relates to wastage, damage, inconvenience of use or excessive consumables shall be fed back to research and development and change control as input for subsequent product improvement. No environmental optimization shall compromise product safety, efficacy, regulatory compliance or patient access.

 

Article 8 End-of-Life Management

New product development shall assess in advance the pathways for recovery, reuse or compliant disposal of discontinued, expired or damaged products and of residues after use. Expired medicinal products, medical waste and production residues shall be classified as hazardous waste or general solid waste and entrusted to qualified operators for disposal in accordance with law. Illegal dumping or mixing with household waste is prohibited. Subject to pharmaceutical regulatory requirements, packaging and separable components shall, to the extent practicable, be designed to be recyclable, reusable or biodegradable, and such attributes shall be documented in the design file. Product cessation and discontinuation shall be incorporated into quality risk management, with concurrent plans for the clearance and compliant disposition of inventories, packaging materials, samples and waste, so as to avoid residual environmental and compliance risks.

 

Article 9 Miscellaneous

This Policy has been reviewed and approved by the ESG Committee under the Board of Directors. The ESG Committee shall report regularly to the Board on the implementation of this Policy and provide recommendations for the Board’s decision-making and supervision.

The ESG Committee has overall responsibility for the implementation, supervision and periodic review of this Policy. The ESG Committee is responsible for the interpretation and amendment of this Policy.

Matters not covered herein shall be handled in accordance with applicable laws, regulations and normative documents.

This Policy shall take effect from the date of issuance.

Livzon Pharmaceutical Group Inc.

September 2026

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