Core Viewpoint - YKYY013 injection, developed by Yuyuan Pharmaceutical's subsidiary, has received FDA approval for clinical trials targeting chronic hepatitis B virus infection [1] Company Summary - Yuyuan Pharmaceutical's subsidiary, Beijing Yuyuan Kete Pharmaceutical Technology Co., Ltd., is responsible for the development of YKYY013 injection [1] - The injection is a chemically synthesized double-stranded siRNA drug that utilizes N-acetylgalactosamine (GalNAc) as a ligand [1] - The drug aims to silence the HBV genome transcription messenger RNA through RNA interference, thereby inhibiting the production of hepatitis B pathogen proteins and HBV replication [1] Industry Summary - The clinical application of YKYY013 injection is focused on treating chronic hepatitis B virus infections [1] - The drug is designed to create conditions for host immune reconstitution, ultimately aiming for functional cure of hepatitis B [1]

Core Viewpoint - YKYY013 injection, developed by the company and its subsidiary, has received FDA approval to proceed with clinical trials for the treatment of chronic hepatitis B virus infection [1] Group 1: Company Developments - The company’s subsidiary, Beijing YKang Kechuang Pharmaceutical Technology Co., Ltd., has obtained a Study May Proceed Letter from the FDA for YKYY013 injection [1] - YKYY013 is a chemically synthesized double-stranded siRNA drug that utilizes an N-acetylgalactosamine ligand for RNA interference to silence HBV mRNA [1] Group 2: Product Details - The drug aims to inhibit the production of HBV proteins, suppress HBV replication, and create conditions for host immune reconstruction, ultimately targeting functional cure for hepatitis B [1] - The clinical application is specifically focused on treating chronic hepatitis B virus infections [1]

Core Viewpoint - Yuyuan Pharmaceutical (688658) announced that its subsidiary, Beijing Yuyuan Ketech Pharmaceutical Technology Co., Ltd., has received approval from the U.S. Food and Drug Administration (FDA) to conduct clinical trials for YKYY013 injection for the treatment of chronic hepatitis B virus infection [1] Company Summary - Yuyuan Pharmaceutical's subsidiary has obtained FDA approval for clinical trials [1] - The drug YKYY013 is aimed at treating chronic hepatitis B virus infection [1] Industry Summary - The approval from the FDA highlights the ongoing developments in the pharmaceutical industry, particularly in the area of hepatitis B treatments [1]

Core Viewpoint - YKYY013 injection, developed by the company and its subsidiary, has received FDA approval to proceed with clinical trials for the treatment of chronic hepatitis B virus infection [1] Group 1: Company Developments - The company’s subsidiary, Beijing YK Innovation Pharmaceutical Technology Co., Ltd., has obtained a Study May Proceed Letter from the FDA for YKYY013 injection [1] - YKYY013 is a chemically synthesized double-stranded siRNA drug that utilizes an N-acetylgalactosamine ligand [1] Group 2: Product Details - YKYY013 works through RNA interference to effectively silence the HBV genome's messenger RNA, thereby inhibiting the production of hepatitis B viral proteins and replication [1] - The drug aims to create conditions for host immune reconstitution, ultimately achieving functional cure for hepatitis B [1]

悦康药业公告，其子公司悦康科创的YKYY13注射液近日获得美国FDA批准进行临床试验，用于治疗慢 性乙型肝炎病毒感染。YKYY13注射液是一种由悦康科创和杭州天龙药业自主研发的双链siRNA药物， 旨在通过RNA干扰作用，抑制乙肝病毒复制和病原蛋白产生，从而实现乙肝的功能性治愈。临床前研 究显示，该药物在体内外具有显著的HBV抑制活性，并在动物试验中表现出良好的安全性和耐受性。 FDA的批准标志着该药物研发的阶段性成功，但公司提醒投资者药物研发具有不确定性。 ...

Investment Rating - The report maintains a "Recommended" investment rating for the pharmaceutical industry as of September 21, 2025 [1] Core Insights - The trend of Chinese innovative drugs going global is a significant industry trend, with a notable increase in License-out transactions in the first half of 2025, surpassing the total number for 2024 by over half and increasing transaction amounts by 16% [2] - The report highlights the importance of structural opportunities within the industry, emphasizing the need to select high-quality companies amidst the competitive landscape [2] - The report notes that while the trend of innovative drugs going abroad continues, concerns have arisen due to fewer major transactions and proposed U.S. regulations affecting Chinese drug licensing [2] - The report identifies significant breakthroughs in small nucleic acid drugs, particularly in chronic disease areas such as hypertension, with notable partnerships and potential milestone payments [3] - The report discusses promising clinical data from Chinese ADCs presented at the World Lung Cancer Conference, showcasing competitive advantages in efficacy and safety [4] - The report mentions the advancements in GLP-1 analogs for weight loss, with ongoing developments from both multinational corporations and domestic companies [5] - The CXO sector is expected to gradually recover, driven by an increase in orders and favorable policy changes [6] - The report outlines the completion of expert reviews for the 2025 medical insurance negotiation and commercial insurance innovative drug directories, indicating potential impacts on participating companies [7] Summary by Sections 1. Pharmaceutical Market Tracking - The pharmaceutical industry index has underperformed compared to the CSI 300 index, with a recent weekly decline of 2.07% [22] - Over the past month, the industry has lagged behind the CSI 300 index by 7.79 percentage points [23] 2. Pharmaceutical Sector Trends and Valuation - The current PE (TTM) for the pharmaceutical industry index is 39.77, above the five-year historical average of 31.50 [48] 3. Recent Research Achievements - The report includes various recent research outputs, highlighting the ongoing focus on innovative drug development and market opportunities [50] 4. Recent Industry Policies and News - The report details recent policy updates from the National Medical Insurance Administration regarding drug directory adjustments and the implications for the industry [52][54]

Investment Rating - The report maintains a "Buy" rating for the company with a target price of 25.35 CNY, based on a 65x PE valuation for 2026 [4][9]. Core Views - The company's performance is under pressure due to the price adjustment of its core product, Ginkgo biloba extract injection, which has significantly impacted revenue and profit margins [12]. - The company is accelerating its small nucleic acid drug pipeline, which shows potential for international expansion, with several products already in clinical trials in both China and the United States [12]. - Increased investment in R&D is evident, with R&D expenses rising to 2.1 billion CNY, accounting for 17.9% of revenue, indicating a commitment to innovation [12]. Financial Performance Summary - Revenue is projected to decline from 4,196 million CNY in 2023 to 3,107 million CNY in 2025, reflecting a year-on-year decrease of 17.8% [6]. - Operating profit is expected to drop significantly to 76 million CNY in 2025, down from 232 million CNY in 2023, with a projected recovery in subsequent years [6]. - The net profit attributable to the parent company is forecasted to decrease to 57 million CNY in 2025, a decline of 53.7% compared to 2023 [6]. - The gross margin is expected to decline to 49.3% in 2025, with a gradual recovery projected thereafter [6].

Investment Rating - The report maintains a "Buy" rating for the company with a target price of 25.35 CNY, based on a 65 times PE valuation for 2026 [4][9]. Core Views - The company's performance is under pressure due to the price adjustment of its core product, Ginkgo biloba extract injection, which has significantly impacted revenue and profit margins [12]. - The company is accelerating its small nucleic acid drug pipeline, which shows potential for international market expansion [12]. - Increased investment in R&D is noted, with R&D expenses projected to rise, indicating a commitment to innovation [12]. Financial Performance Summary - Revenue for 2025 is expected to decline to 3,107 million CNY, a decrease of 17.8% year-on-year, with a gradual recovery projected in subsequent years [6]. - Operating profit is forecasted to drop to 76 million CNY in 2025, reflecting a 52.0% decline, but is expected to rebound significantly in 2026 [6]. - Net profit attributable to the parent company is projected to be 57 million CNY in 2025, down 53.7% from the previous year, with a recovery anticipated in 2026 [6]. - The company’s gross margin is expected to decrease to 49.3% in 2025, with a gradual improvement in the following years [6]. R&D and Product Pipeline - The company has 42 ongoing R&D projects, including 21 innovative drugs and 21 generic drugs, with several key products in the NDA review stage [12]. - The small nucleic acid drug YKYY015 and YKYY029 are undergoing clinical trials in both China and the US, indicating strong development activity [12]. - The company has also received FDA approval for its RSV and VZV mRNA vaccines, showcasing its expanding product portfolio [12].

Core Viewpoint - Yuyuan Pharmaceutical experienced a 5.08% increase in stock price, reaching 25.88 CNY per share, with a total market capitalization of 11.646 billion CNY as of September 18 [1] Group 1: Company Overview - Yuyuan Pharmaceutical Group Co., Ltd. was established on August 14, 2001, and went public on December 24, 2020 [1] - The company focuses on the research and production of high-end chemical drugs, with significant revenue contributions from cardiovascular, digestive, diabetes, and anti-infection medications [1] - Major products include Ginkgo biloba extract injection, Tianma injection, Lansoprazole injection, Omeprazole enteric-coated capsules, Metformin sustained-release tablets, Cefuroxime sodium injection, and Ceftriaxone sodium injection, which are expected to drive future growth [1] Group 2: Revenue Composition - The revenue composition of Yuyuan Pharmaceutical is as follows: - Cardiovascular drugs: 55.67% - Anti-infection drugs: 20.88% - Raw materials: 8.73% - Digestive system drugs: 6.87% - Diabetes drugs: 4.85% - Others: 2.62% - Supplementary: 0.36% - Technical services: 0.02% [1] Group 3: Shareholder Information - Yuyuan Pharmaceutical's top circulating shareholder includes a fund from E Fund Management, specifically the E Fund Healthcare Industry Mixed A (110023), which entered the top shareholders list in Q2 with 6.8551 million shares, representing 1.52% of circulating shares [2] - The fund has achieved a year-to-date return of 48.1% and a one-year return of 57.01% [2]

Investment Rating - The report maintains a "Recommended" investment rating for the pharmaceutical industry as of September 15, 2025 [1] Core Insights - The trend of Chinese innovative drugs going overseas continues, with a focus on selective opportunities. The report highlights that the global pharmaceutical transaction volume reached 456 deals in the first half of 2025, a 32% year-on-year increase, with upfront payments totaling $11.8 billion, a 136% surge, and total transaction value hitting $130.4 billion, up 58% year-on-year [2] - The report emphasizes the promising clinical data from Chinese innovative drugs presented at the World Lung Cancer Conference, particularly in the ADC (Antibody-Drug Conjugate) field, showcasing significant efficacy advantages [3] - The report discusses the potential of small nucleic acid drugs and innovative delivery systems, indicating new market opportunities arising from strategic collaborations between Chinese companies and multinational corporations [4] - The CXO (Contract Research Organization) sector is expected to gradually recover, with a notable increase in orders anticipated in the third quarter of 2025, driven by improved innovation environments and funding from license-out transactions [5] - The 2025 medical insurance negotiation and commercial insurance innovative drug directory work has commenced, with a focus on orphan drugs and breakthrough treatment varieties [6] Summary by Sections 1. Pharmaceutical Market Tracking - The pharmaceutical industry underperformed the CSI 300 index by 1.75% in the past week, with a recent one-month increase of 3.32%, lagging behind the CSI 300 by 5.81% [22][26] - The medical device sector showed the highest weekly increase of 2.23%, while the chemical pharmaceutical sector experienced a decline of 2.57% [31] 2. Pharmaceutical Sector Trends and Valuation - The pharmaceutical industry index's current PE (TTM) stands at 40.60, above the five-year historical average of 31.60 [46] - The report notes that the pharmaceutical sector has shown a 15.06% increase over the past three months, outperforming the CSI 300 by 16.11% [43] 3. Recent Research Achievements - The report outlines recent research achievements by the Huaxin pharmaceutical team, including various in-depth and commentary reports on innovative drug developments and market trends [50] 4. Recent Industry Policies and News - The report details recent policy updates from the National Healthcare Security Administration regarding the 2025 drug directory adjustments and the approval of new drug applications [52][55]