First Public Notice of the Completion Environmental Protection Acceptance for the Innovation Capacity Building Project of the Technical Center of Wuhan Qirui Pharmaceutical Co., Ltd.

In accordance with the Environmental Impact Assessment Law of the People’s Republic of China and the Interim Measures for Public Participation in Environmental Impact Assessment issued by the State Environmental Protection Administration under Document No. 28 [2006], the following announcement is hereby made regarding matters related to the “Innovation Capacity Building Project for the Technical Center of Wuhan Qirui Pharmaceutical Co., Ltd.”:

1. Name and Overview of the Construction Project

1. Project Name: Innovation Capability Development Project for the Technical Center of Wuhan Qirui Pharmaceutical Co., Ltd.

2. Construction Site: Miaoshan Community, Wuhan East Lake New Technology Development Zone.

3. Project Overview: Wuhan Qirui Pharmaceutical Co., Ltd. is located in Miaoshan Residential Area of the East Lake New Technology Development Zone in Wuhan. The company’s original project comprised two phases of construction. Phase I was the GMP-compliant construction project for Wuhan Qirui Pharmaceutical Co., Ltd., primarily producing arginine ornithine API, arginine ornithine injection, arginine ornithine solid dosage forms, and sofosbuvir solid dosage forms, among others. This phase received environmental impact assessment approval from the Jiangxia District Environmental Protection Bureau of Wuhan City in August 2005 (Document No. [2005]29 of the Jiangxia District Environmental Protection Bureau; see Appendix 5) and completed竣工 environmental protection acceptance inspection in May 2011 (see Appendix 6). Phase II was the Qirui Pharmaceutical Biopharmaceutical Industrial Base (Phase II) project, mainly producing arginine ornithine lyophilized powder for injection, fasudil mesylate lyophilized powder for injection, cinepazide maleate injection, quinapril hydrochloride tablets, sofosbuvir dry suspension, entecavir tablets,ertapenem lyophilized powder for injection, and quinapril tablets, among others. This phase received environmental impact assessment approval from the Wuhan Municipal Environmental Protection Bureau in April 2012 (Document No. [2012]16 of the Wuhan Municipal Environmental Protection Bureau; see Appendix 5) and completed竣工 environmental protection acceptance inspection in January 2015 (Document No. [2015]1 of the Wuhan Municipal Environmental Protection Bureau; see Appendix 6).

To further enhance its capabilities in biopharmaceutical R&D and industrialization, Wuhan Qirui Pharmaceutical Co., Ltd. has invested RMB 30.77 million, with actual environmental protection investment totaling RMB 300,000, to implement the Wuhan Qirui Pharmaceutical Co., Ltd. Technology Center Innovation Capacity Building Project within the formulation workshop of the existing Qirui Pharmaceutical Biopharmaceutical Industrial Base (Phase II). The main construction components include the establishment of a QC laboratory and a standard formulation R&D laboratory, along with the procurement of supporting laboratory instruments and equipment as well as information technology software.

This project is a renovation and expansion initiative that commenced on October 7, 2020, was completed on February 15, 2022, and entered trial operation on February 20, 2022. Currently, the plant employs a total of 245 staff; this acceptance inspection covers an additional 35 production personnel. The project operates on an eight-hour workday schedule with 250 working days per year. The scope of the acceptance inspection includes the QC laboratory, the formulation R&D standard laboratory, and the associated environmental protection facilities. The QC laboratory primarily conducts physicochemical testing—such as determination of drug physicochemical properties, including dissolution testing, particle size analysis, and liquid chromatography—and microbiological testing—specifically sterility testing for sterile preparations and microbial limit testing for other pharmaceutical products; however, it does not fall under the category of P3 or P4 biosafety laboratories. The formulation R&D standard laboratory is mainly engaged in small-scale formulation development, process validation and quality research, method validation, and stability studies, but does not involve pilot-scale trials.

This project is located within the formulation workshop (3rd floor) of Phase II of Wuhan Qirui Pharmaceutical Co., Ltd. It makes use of the vacant space on the third floor of the formulation workshop. To the east of the project lies the plant access road and perimeter wall, with Jinghu Road No. 1 immediately beyond the wall; to the south, across the plant access road, stands the Engineering Building (2nd floor); to the west, adjacent to the Comprehensive Warehouse (3rd floor); and to the north, across the plant access road, is the Comprehensive Production Plant (1st floor).

On September 21, 2022, Wuhan Qirui Pharmaceutical Co., Ltd. established an acceptance team to conduct an inspection and acceptance of the environmental protection measures implemented upon completion of the Technical Center Innovation Capacity Development Project. The acceptance team included representatives from Wuhan Qirui Pharmaceutical Co., Ltd. (the project proponent), and experts were invited to participate in the inspection and acceptance process.

II. Project Construction Entity and Contact Information

1. Project Owner: Wuhan Qirui Pharmaceutical Co., Ltd.

2. Contact Number: Manager Zhang, 15271845911

III. Procedures for Completion Environmental Protection Acceptance

Collecting data, conducting on-site surveys, performing investigative analysis, monitoring the current environmental conditions, forecasting and evaluating environmental impacts, carrying out comprehensive analyses (including total pollutant control, public participation, environmental management, environmental monitoring, and environmental protection measures), drawing conclusions, preparing the report form, and undergoing expert review.

IV. Main Issues for Public Consultation

(1) Are the public satisfied with the current environmental quality at the site of the proposed project?

(2) The main factors affecting local environmental quality and the primary sources of environmental pollution;

(3) The public’s awareness of and response to the construction project;

(4) After the public has become informed about the construction project, what is their attitude toward its implementation from an environmental protection perspective?

(5) What suggestions and requirements does the public have regarding the environmental protection aspects of this construction project?

V. Main Methods for Public Submission of Comments

Submit written comments to the project proponent, the environmental impact assessment agency, or the administrative department in charge of environmental protection by letter, email, or other means.

VI. Period for Public Submission of Comments

Within 20 working days from the date of public notice of this project, the general public may submit valuable comments to the project proponent, the environmental impact assessment agency, or the administrative authority for environmental protection.

November 17, 2022