Core Viewpoint - The company, Xinji Pharmaceutical-B, is an innovative pharmaceutical technology enterprise that has submitted its IPO application to the Hong Kong Stock Exchange, aiming to raise funds for the development of its proprietary drug delivery technologies and products [1]. Company Overview - Xinji Pharmaceutical-B was founded in 2007 and is headquartered in Guangzhou, China, focusing on the development and commercialization of high-end formulation drugs to address limitations of traditional drug delivery methods [1]. - The company has developed two core technology platforms: (1) soluble microneedle formulation technology platform and (2) nasal inhalation formulation technology platform [1][5]. Financial Performance - The company's revenue for 2024 is projected at approximately RMB 0.49 billion, with a net loss of RMB 1.47 billion. For the first half of 2025, revenue is expected to be RMB 0.28 billion, with a reduced net loss of RMB 0.21 billion, showing a year-on-year improvement of over 50% [1]. - R&D expenditure accounts for over 40% of the company's revenue, indicating a strong focus on innovation [1]. - As of June 30, 2025, the company had cash reserves of approximately RMB 0.5 billion and short-term loans of RMB 0.24 billion, with an operating cash flow of approximately -RMB 0.19 billion for the first half of the year [8]. Product Pipeline - The core product, Dexmedetomidine Microneedle Patch, is the first soluble microneedle transdermal drug delivery system approved for clinical trials in China, targeting preoperative sedation for pediatric and adult patients. It is currently in Phase IIa clinical trials for children and Phase II trials for adults, expected to commence in Q1 2026 [3]. - Another product, XJN010, is a nasal inhalation formulation for on-demand treatment of "off" episodes in Parkinson's disease patients undergoing Levodopa therapy, currently in Phase II clinical trials in China [4]. Market Overview - According to Frost & Sullivan, the global sedative market is experiencing stable growth, with the market size expected to increase from USD 8.64 billion in 2020 to USD 9.11 billion in 2024, reflecting a compound annual growth rate (CAGR) of 1.33%. The growth is anticipated to accelerate to a CAGR of 1.58% from 2024 to 2028, reaching USD 10.39 billion by 2032 [9]. - The global Parkinson's disease "off" episode market has grown from USD 5.03 billion in 2020 to USD 7.22 billion in 2024, achieving a CAGR of 10.12%. It is projected to exceed USD 10.62 billion by 2028, with a CAGR of 11.27% from 2024 to 2028, and reach USD 15.03 billion by 2032 [9]. Comparable Companies - Comparable companies in the industry include Green Leaf Pharmaceutical and Health Yuan, with respective market capitalizations and financial metrics provided for comparison [15][16].

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]

Core Viewpoint - The company, Xinji Pharmaceutical, is a clinical-stage innovative pharmaceutical technology enterprise that relies heavily on CRO (Contract Research Organization) services and MAH (Marketing Authorization Holder) business, with no self-developed commercialized products to date [1][2]. Business Model and Operations - Xinji Pharmaceutical's core business focuses on the development and commercialization of high-end formulation new drugs, utilizing two main technology platforms: soluble microneedle formulations and nasal inhalation formulations [1]. - The company has no self-developed commercialized products, with revenue primarily derived from CRO services and MAH business [1]. - The MAH business previously included sales of esomeprazole magnesium sustained-release capsules and propofol emulsion injection, but the propofol product was discontinued in January 2024, leaving only esomeprazole magnesium sustained-release capsules [1]. Revenue and Changes - The company's revenue has shown volatility over the past three years, with a 9.4% decline in 2024 due to a contraction in MAH business, while the first half of 2025 saw a recovery driven by increased CRO service orders [2]. - Revenue figures (in million RMB) are as follows: 2023: 541.20, 2024: 490.0 (down 9.4%), 2025 (H1): 281.0 (up 23.8% compared to 2024) [2]. Profit and Loss - The company has experienced continuous net losses over the past three years, with a significant increase in losses of 131% in 2024, totaling over 300 million RMB in cumulative losses [3]. - Net loss figures (in million RMB) are as follows: 2023: 0, 2024: +131.0%, 2025 (H1): -22.1% compared to 2024 [3]. Gross and Net Margins - The company's gross margin has declined by 7.4 percentage points over three years, with a gross margin of 27.7% in the first half of 2025, primarily due to the increasing proportion of lower-margin CRO services [4]. - Gross margin figures are as follows: 2023: 35.1%, 2024: 33.7% (down 1.4 percentage points), 2025 (H1): 27.7% (down 6.0 percentage points) [4]. Revenue Composition - In 2024, CRO service revenue accounted for 72.3% of total revenue, while MAH business revenue dropped to 27.7% [7]. - Following the discontinuation of propofol emulsion injection, the MAH business now relies solely on esomeprazole magnesium sustained-release capsules, which face pricing and competition risks [7]. Customer and Supplier Concentration - The company has seen a significant increase in customer concentration, with the top five customers contributing 58.1% of revenue in the first half of 2025, up from 48.6% in 2023 [8]. - Supplier concentration is also high, with the top five suppliers accounting for 55.7% of purchases, indicating a reliance on a limited number of suppliers for core production [9]. Shareholder Structure - The company is controlled by the Wu Chuanbin family, holding 51.01% of shares, leading to a concentrated ownership structure that may pose risks related to decision-making and potential conflicts of interest [10]. Management Team - The management team, led by Chairman Wu Chuanbin, has a strong research background but lacks extensive commercial experience, raising concerns about the company's ability to effectively commercialize its products [11]. Financial Risks - The company faces significant financial risks, including a high debt-to-asset ratio of 687% and insufficient cash reserves to sustain operations beyond three months [13].

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]

Core Insights - Guangzhou Xinji Pharmaceutical Co., Ltd. has submitted its listing application to the Hong Kong Stock Exchange, with Guotai Junan acting as the sole sponsor [1] - Founded in 2007, the company is an innovation-driven pharmaceutical technology enterprise based in Guangzhou, China, currently in the clinical stage [1] - The company has developed two core technology platforms: (i) soluble microneedle formulation technology platform and (ii) nasal inhalation formulation technology platform [1] - Xinji Pharmaceutical has two core products and three additional pipeline products, with the first core product being a microneedle patch of dexmedetomidine hydrochloride for preoperative sedation in pediatric and adult patients [1] - As of December 18, 2025, the microneedle patch has entered Phase IIa clinical trials for pediatric patients in China, with NMPA approval for Phase II clinical trials in adult patients expected to start in Q1 2026 [1] - The second core product, XJN010, is a nasal inhalation formulation developed for on-demand treatment of "off" episodes in Parkinson's disease patients, which has also entered Phase II clinical trials in China as of December 18, 2025 [1]

Group 1 - The core viewpoint of the article is that Guangzhou Xinji Pharmaceutical Co., Ltd. has submitted its listing application to the Hong Kong Stock Exchange, with Guotai Junan as its sole sponsor [1] - Xinji Pharmaceutical, founded in 2007, is an innovative pharmaceutical technology company based in Guangzhou, China, currently in the clinical stage [1] - The company has developed two core technology platforms: (i) soluble microneedle formulation technology platform and (ii) nasal inhalation formulation technology platform [1] Group 2 - Xinji Pharmaceutical has developed two core products and three additional pipeline products [1] - The first core product, dexmedetomidine microneedle patch, is designed for preoperative sedation in pediatric and adult patients, with IIa clinical trials for children already initiated in China [1] - The second core product, XJN010, is a nasal inhalation formulation developed for on-demand treatment of Parkinson's disease patients during "off" periods, currently in II phase clinical trials in China [1]

Group 1 - Guangzhou New Ji Pharmaceutical Co., Ltd. (New Ji Pharmaceutical) has submitted a listing application to the Hong Kong Stock Exchange, with Guotai Junan as its sole sponsor [1] - Founded in 2007, New Ji Pharmaceutical is an innovation-driven pharmaceutical technology company based in Guangzhou, China, currently in the clinical stage [1] - The company has developed two core technology platforms: (i) soluble microneedle formulation technology platform and (ii) nasal inhalation formulation technology platform [1] Group 2 - New Ji Pharmaceutical has developed two core products and three additional pipeline products, with the first core product being dexmedetomidine microneedle patch for preoperative sedation in pediatric and adult patients [1] - As of December 18, 2025, the dexmedetomidine microneedle patch has entered Phase IIa clinical trials for pediatric patients in China, with NMPA approval for Phase II clinical trials for adult patients expected to start in Q1 2026 [1] - The second core product, XJN010, is a nasal inhalation formulation developed for on-demand treatment of "off" episodes in Parkinson's disease patients, which has also entered Phase II clinical trials in China as of December 18, 2025 [1]

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 ...