Core Viewpoint - New Ji Pharmaceutical has submitted a listing application to the Hong Kong Stock Exchange, with Guotai Junan as the exclusive sponsor [1] Group 1: Technology Platforms - The company has developed two core technology platforms: soluble microneedle formulation technology platform and nasal inhalation formulation technology platform [1] Group 2: Core Products - The first core product is a dexmedetomidine microneedle patch aimed at providing a painless and convenient transdermal delivery method for preoperative sedation in both children and adult patients. This product is currently in Phase IIa clinical trials for pediatric patients in China, with Phase II trials for adult patients expected to begin in Q1 2026 [1] - The second core product, XJN010, is based on the nasal inhalation formulation platform and aims to deliver drugs rapidly through the nasal-brain pathway. It is currently in Phase II clinical trials in China [1] Group 3: Pipeline Products - The company has two additional products in the preclinical stage: XJN1102 (a soluble microneedle patch for adult type 2 diabetes and weight control, with plans to submit an IND application to NMPA and FDA in Q4 2026) and XJN2503 (a nasal inhalation formulation for the relief and prevention of chemotherapy-related nausea and vomiting, also planned for IND submission to NMPA in Q4 2026) [1]

Company Overview - Guangzhou Xinji Pharmaceutical Co., Ltd. is an innovative pharmaceutical technology company founded in 2007, headquartered in Guangzhou, China [2] - The company has developed two core technology platforms: (i) soluble microneedle formulation technology and (ii) nasal inhalation formulation technology [2] - Xinji Pharmaceutical has two core products and three additional pipeline products [2] Core Products - The first core product, Dexmedetomidine Hydrochloride Microneedle Patch, is designed for preoperative sedation in pediatric and adult patients, aiming to improve patient comfort and clinical efficiency by providing a transdermal delivery method [2] - As of December 18, 2025, the Dexmedetomidine patch has entered Phase IIa clinical trials for pediatric patients in China, with Phase II trials for adults expected to start in Q1 2026 [2] - The second core product, XJN010, is a nasal spray developed to deliver active pharmaceutical ingredients via the nasal-brain pathway, bypassing the gastrointestinal tract and blood-brain barrier, and is currently in Phase II clinical trials [3] - Additional products include XJN1102, a microneedle patch for treating type 2 diabetes, and XJN2503, a nasal inhalation formulation for nausea and vomiting related to chemotherapy and surgery, both expected to submit IND applications in Q4 2026 [3] Financial Information - Research and development expenses for the fiscal years 2023, 2024, and the first half of 2025 were approximately CNY 18.43 million, CNY 16.41 million, and CNY 11.62 million, respectively [4] - Revenue for the fiscal years 2023, 2024, and the first half of 2025 was approximately CNY 54.09 million, CNY 49.03 million, and CNY 28.14 million, respectively [5] Industry Overview - The preoperative sedation market in China is expected to grow from 9.06 million pediatric patients in 2020 to 10.23 million by 2032, with a compound annual growth rate (CAGR) increasing from 0.40% (2020-2024) to 1.79% (2028-2032) [6] - The adult sedation patient population is projected to grow from 35.49 million in 2020 to 39.04 million by 2032, with a stable growth trend [6] - The overall preoperative sedation market in China was valued at approximately CNY 7.36 billion in 2020, with expectations to exceed CNY 7.6 billion by 2024 and reach CNY 8.24 billion by 2032, driven by increased surgical volumes and demand for patient comfort [7] - The global sedation market is also expanding, with a projected growth from USD 8.64 billion in 2020 to USD 10.39 billion by 2032, with pediatric sedation growing at a faster rate than adult sedation [8]

Company Overview - Xinji Pharmaceutical, founded in 2007 and headquartered in Guangzhou, China, is an innovative pharmaceutical technology company in the clinical stage, focusing on two core technology platforms: soluble microneedle formulation technology and nasal inhalation formulation technology [3] - The company's first core product, Dexmedetomidine Hydrochloride Microneedle Patch, is designed for preoperative sedation in pediatric and adult patients, aiming to enhance patient comfort and clinical efficiency by overcoming the limitations of intravenous sedatives [3] - As of December 18, 2025, the Dexmedetomidine Hydrochloride Microneedle Patch has entered Phase IIa clinical trials for pediatric patients in China, with Phase II trials for adult patients expected to commence in Q1 2026 [3] Product Pipeline - The second core product, XJN010, is developed based on the nasal inhalation formulation platform, aiming to deliver active pharmaceutical ingredients through the nasal-brain pathway, bypassing the gastrointestinal tract and blood-brain barrier [4] - XJN1102, a soluble microneedle transdermal patch for treating type 2 diabetes and long-term weight control, is in the preclinical stage, with IND applications planned for submission to NMPA and FDA in Q4 2026 [4] - XJN2503, a clinical-stage nasal inhalation formulation for rapid relief and prevention of nausea and vomiting related to chemotherapy, radiotherapy, and postoperative recovery, is also set for IND submission to NMPA in Q4 2026 [4] Financial Information - Research and development expenses for the fiscal years 2023, 2024, and the first half of 2025 were approximately RMB 18.43 million, RMB 16.41 million, and RMB 11.62 million, respectively [5] - Revenue for the fiscal years 2023, 2024, and the first half of 2025 was approximately RMB 54.09 million, RMB 49.03 million, and RMB 28.14 million, respectively [6] Industry Overview - The preoperative sedation market in China is expected to grow steadily, with the pediatric sedation patient population projected to increase from 9.06 million in 2020 to 10.23 million by 2032, reflecting a compound annual growth rate (CAGR) of 1.79% from 2028 to 2032 [8] - The overall market for preoperative sedation in China was approximately RMB 7.36 billion in 2020, with expectations to exceed RMB 7.6 billion by 2024 and reach around RMB 8.24 billion by 2032, driven by rising surgical volumes and increased demand for comfort-oriented medical services [12] - The global sedation market is also expanding, with a projected growth from USD 8.64 billion in 2020 to USD 10.39 billion by 2032, with pediatric sedation showing a higher growth rate compared to adult sedation [14]

Company Overview - Xinji Pharmaceutical, founded in 2007 and headquartered in Guangzhou, China, is an innovative pharmaceutical technology company in the clinical stage, developing two core technology platforms: soluble microneedle formulation technology and nasal inhalation formulation technology [3] - The first core product, dexmedetomidine hydrochloride microneedle patch, is designed for preoperative sedation in pediatric and adult patients, aiming to enhance patient comfort and clinical efficiency by providing a painless alternative to intravenous sedation [3] - The second core product, XJN010, is based on the nasal inhalation platform, intended for rapid drug delivery to the brain, bypassing the gastrointestinal tract and blood-brain barrier, particularly suitable for patients with sudden onset conditions [4] Financial Information - Research and development expenses for the fiscal years 2023, 2024, and the first half of 2025 were approximately RMB 18.43 million, RMB 16.41 million, and RMB 11.62 million respectively [5] - Revenue for the fiscal years 2023, 2024, and the first half of 2025 was approximately RMB 54.09 million, RMB 49.03 million, and RMB 28.14 million respectively [6] Industry Overview - The preoperative sedation market in China is expected to grow steadily, with the pediatric sedation patient population projected to increase from 9.06 million in 2020 to 10.23 million by 2032, reflecting a compound annual growth rate (CAGR) of 1.79% from 2028 to 2032 [8] - The overall market size for preoperative sedation in China was approximately RMB 7.36 billion in 2020, with expectations to exceed RMB 7.6 billion by 2024 and reach around RMB 8.24 billion by 2032, driven by increased surgical volumes and a growing demand for comfort-oriented medical services [12] - The global sedation market is also experiencing stable growth, with the market size projected to increase from USD 8.64 billion in 2020 to USD 10.39 billion by 2032, with pediatric sedation showing a higher growth rate compared to adult sedation [14]

The Stock Exchange of Hong Kong Limited and the Securities and Futures Commission take no responsibility for the contents of this Application Proof, make no representation as to its accuracy or completeness and expressly disclaim any liability whatsoever for any loss howsoever arising from or in reliance upon the whole or any part of the contents of this Application Proof. Application Proof of Guangzhou Novaken Pharm Co., Ltd. 廣州新濟醫藥股份有限公司 (the "Company") (A joint stock company established in the People's R ...

香港聯合交易所有限公司與證券及期貨事務監察委員會對本申請版本的內容概不負責，對其準確性或完整性亦 不發表任何意見，並明確表示概不就因本申請版本全部或任何部分內容而產生或因倚賴該等內容而引致的任何 損失承擔任何責任。 Guangzhou Novaken Pharm Co., Ltd. 廣州新濟醫藥股份有限公司 （「本公司」） （於中華人民共和國註冊成立的股份有限公司） 的申請版本 警告 本申請版本乃根據香港聯合交易所有限公司（「聯交所」）及證券及期貨事務監察委員會（「證監會」） 的要求而刊發，僅用作向香港公眾人士提供資料。 本申請版本為草擬本，其內所載資料並不完整，亦可能會作出重大變動。 閣下閱覽本文件， 即代表 閣下知悉、接納並向本公司、其獨家保薦人、獨家整體協調人、顧問或包銷銀團成員 表示同意： 倘於適當時候向香港公眾人士提出要約或邀請，有意投資者務請僅依據與香港公司註冊處處長 註冊的本公司招股章程作出投資決定；招股章程的文本將於發售期內向公眾人士刊發。 (i) 本文件僅為向香港公眾人士提供有關本公司的資料，概無任何其他目的。投資者不應根據 本文件中的資料作出任何投資決定； (ii) 在聯交所網站登載本文件 ...