Core Viewpoint - Changchun High-tech has received approval for clinical trials of its drug, Cabergoline Tablets, aimed at treating hyperprolactinemia and pituitary prolactin adenomas, marking a significant step in addressing unmet clinical needs in this area [1][2] Group 1: Product Development - Cabergoline Tablets are a dopamine receptor agonist with effective activity on dopamine D2 receptors, classified as a chemical drug of category 3, intended for the treatment of hyperprolactinemia and pituitary prolactin adenomas [1] - The drug has been approved for clinical trials in China, which will facilitate its clinical development and address unmet clinical needs for patients [2] - The original product of Cabergoline has been approved in over 80 countries since 1992, making it a first-line treatment for hyperprolactinemia and pituitary prolactin adenomas [2] Group 2: Market Context - Hyperprolactinemia is a common endocrine disorder, particularly among young women, with an annual incidence rate of 23.9 per 100,000 for women aged 25 to 34 [1] - The condition is prevalent in 10% to 25% of patients with secondary amenorrhea and 70% to 80% of patients with amenorrhea and galactorrhea, with 20% to 30% of hyperprolactinemia patients having pituitary tumors, primarily prolactinomas [1] Group 3: Company Strategy and Other Developments - Changchun High-tech is involved in various pharmaceutical sectors, including gene engineering, biological vaccines, antibody drugs, high-end chemical drugs, and modern traditional Chinese medicine [2] - The company has also received approvals for other products, including GenSci098 for thyroid eye disease and GenSci122 for advanced solid tumors, indicating a robust pipeline of clinical trials [3] - Additionally, the company plans to issue H-shares and list on the Hong Kong Stock Exchange to enhance its international presence and financing capabilities [4]

Group 1 - Changchun High-tech's subsidiary Brillian Pharma INC. received FDA approval for the oral solution of benzenesulfonic acid amlodipine, targeting hypertension in individuals aged 6 and above, as well as chronic stable angina and vasospastic angina in adults [1] - The prevalence of hypertension among adults in the U.S. was reported at 47.7% from August 2021 to August 2023, while the prevalence among children aged 6-17 was 3.8% [1] - Amlodipine is recommended as a first-line treatment for hypertension in children, aiming to reduce the risk of organ damage and cardiovascular diseases [1] Group 2 - The benzenesulfonic acid amlodipine oral solution is a 505B2 modified innovative drug developed for children over 6 and adults with swallowing difficulties, designed to lower blood pressure and reduce cardiovascular event risks [2] - The product is based on existing FDA-approved formulations, offering ease of use, accurate dosing, and palatability, which enhances medication adherence among pediatric patients [2] - The approval of this product is expected to strengthen Brillian Pharma's product portfolio in the U.S. market, enhancing the company's competitiveness in the pharmaceutical sector [2] Group 3 - Changchun High-tech's subsidiary, Changchun Jinsai Pharmaceutical, received approval for the injection of Fushen Qibai monoclonal antibody, a new biological product for treating acute gouty arthritis in adults [3] - The company has diversified its business into various pharmaceutical segments, including gene engineering, biological vaccines, antibody drugs, and modern traditional Chinese medicine [3] Group 4 - The company is advancing clinical trials for several new drugs, including GenSci098 for thyroid eye disease and GenSci122 for advanced solid tumors, both of which have received FDA clinical trial permissions [4] - The company plans to issue H-shares and list on the Hong Kong Stock Exchange to enhance its global strategy and international financing capabilities [4]

Core Viewpoint - The approval of the injection of Vuxinchibai monoclonal antibody marks a significant milestone for the company, enhancing its product portfolio in the adult autoimmune sector and demonstrating the success of its innovation transformation [3]. Group 1: R&D Investment and Innovation - The company's R&D investment for 2024 reached 2.69 billion yuan, an increase of 11.20% year-on-year, accounting for 19.97% of its revenue, up by 3.36 percentage points [4]. - The company has successfully launched several products, including the recombinant human follicle-stimulating hormone injection and the progesterone injection, with the latter included in the 2024 National Medical Insurance Directory [4]. - New products such as the oral suspension of megestrol acetate for cancer-related cachexia and the pediatric cough granules have been introduced, further enriching the product line and expected to contribute to incremental revenue [4]. Group 2: Commercialization and Sales - The company has developed a diverse and high-potential innovation pipeline focusing on children's health, women's health, endocrine & rheumatology, and oncology [5]. - Sales expenses for 2024 amounted to 4.44 billion yuan, reflecting an increase of 11.81% year-on-year, and accounting for 32.97% of revenue, up by 5.71 percentage points [6]. - The sales team has expanded significantly, with an increase of 1,840 personnel to a total of 4,995 by the end of 2024, enhancing the company's commercialization capabilities [6]. Group 3: Global Strategy and Stock Buyback - The company has initiated preparations for H-share listing, aiming to deepen its global strategy and enhance its international financing capabilities [7]. - Since November 2024, the company has been repurchasing its A-shares through centralized bidding, intending to use these shares for future employee stock ownership plans [7].

Investment Rating - The report maintains a "Recommended" investment rating for the pharmaceutical industry [1] Core Insights - The value of innovative drugs going overseas is continuously validated, with an upward trend in valuations expected to persist. The collaboration between Chinese biotech firms and multinational corporations (MNCs) is increasing, particularly in the area of PD-1 and VEGF dual antibodies [2][3] - The recent approval of Vuxin Qibai monoclonal antibody marks the beginning of a new era in biological treatment for gout, highlighting the significant market potential for gout treatments in China and globally [4] - The trend towards more effective and scientific weight loss solutions is emerging, with new clinical data and partnerships in the GLP-1 and other related drug classes [5] - The focus on autoimmune diseases is growing, with significant breakthroughs in drug development and international collaborations [7] Summary by Sections 1. Pharmaceutical Market Tracking - The pharmaceutical industry index increased by 3.64% in the week from June 28 to July 4, 2025, outperforming the CSI 300 index by 2.10 percentage points, ranking 4th among 31 primary industry indices [20] 2. Pharmaceutical Sector Trends and Valuation - The pharmaceutical industry index's current PE (TTM) is 35.12, above the historical five-year average of 32.30 [46] 3. Recent Research Achievements - The report highlights various recent research outputs from the Huaxin pharmaceutical team, including deep reports on the growth trends in blood products and inhalation preparations [52] 4. Recent Industry Policies and News - A recent policy from the National Healthcare Security Administration supports the high-quality development of innovative drugs, emphasizing increased support for R&D and clinical applications [54] - Notable news includes the approval of new drug applications and significant clinical trial advancements by various companies, indicating a vibrant pipeline in the pharmaceutical sector [55][56]

Investment Rating - The report rates the pharmaceutical industry as "Overweight," indicating a positive outlook for the sector compared to the overall market performance [4][27]. Core Insights - The pharmaceutical sector saw a weekly increase of 3.6%, outperforming the Shanghai Composite Index, which rose by 1.4% [4][5]. - The report highlights the introduction of supportive policies for innovative drugs and high-end medical devices, including a comprehensive support system for innovative drug development, access, usage, and payment [4][12]. - The negotiation for the 2025 National Medical Insurance Drug List has officially started, with plans to include innovative drugs in commercial health insurance for the first time [4][13]. - AstraZeneca and Summit are reportedly negotiating a deal worth over $15 billion for the drug AK112, indicating significant activity in the innovative drug market [4][16]. - The report emphasizes the growth in revenue and licensing deals for innovative drugs, suggesting a trend towards broader market expansion [4]. Market Performance - The pharmaceutical sector's overall valuation stands at 29.8 times PE (2025E), ranking 6th among 31 primary industries [4][11]. - The performance of various sub-sectors includes: - Raw materials (+5.8%) - Chemical preparations (+4.9%) - Other biological products (+8.3%) - Medical devices (-0.2%) [4][7]. Key Events - On July 1, the National Healthcare Security Administration and the National Health Commission released measures to support the high-quality development of innovative drugs, outlining 16 specific initiatives [4][12]. - The National Medical Products Administration announced measures to support the innovation of high-end medical devices, focusing on key areas such as medical robots and AI medical devices [4][13]. - Longcheng Gaoxin announced plans to issue H shares and list on the Hong Kong Stock Exchange, enhancing its international brand image [4][15].

Group 1: Nanjing Business Travel - Nanjing Business Travel (600250) expects a net profit of 6 million to 9 million yuan for the first half of 2025, a decrease of 67.4% to 78.27% year-on-year [1] - The net profit excluding non-recurring gains and losses is expected to be between 5.5 million and 8.5 million yuan, down 17.34% to 46.52% year-on-year [1] Group 2: Jihong Co., Ltd. - Jihong Co., Ltd. (002803) anticipates a net profit of 112 million to 119 million yuan for the first half of 2025, an increase of 55% to 65% year-on-year [2] - The net profit excluding non-recurring gains and losses is expected to be between 106 million and 113 million yuan, up 68.16% to 79.62% year-on-year [2] - Basic earnings per share are projected to be between 0.29 yuan and 0.31 yuan [2] Group 3: Zhuhai Design - Zhuhai Design (300564) announced that its actual controller plans to reduce holdings by up to 3% of the company's shares, totaling 483.95 million shares [3] Group 4: Anjisi - Anjisi (688581) disclosed that two shareholders plan to reduce their holdings by up to 2% of the company's shares, totaling 162.27 million shares [4] Group 5: Jingwei Huikai - Jingwei Huikai (300120) intends to acquire a total of 12.44% equity in Nuo Si Wei, with a total transaction price of approximately 1.49 billion yuan [4] - The acquisition will increase the company's control over Nuo Si Wei from 22.12% to 34.56% [4] Group 6: Hainan Highway - Hainan Highway (000886) is planning to purchase 51% equity in Hainan Jiao Control Petrochemical, which will become a subsidiary after the transaction [9] Group 7: *ST Modern - *ST Modern (002656) has applied to revoke other risk warnings but will still face delisting risk warnings due to financial indicators [10] Group 8: Ningde Times - Ningde Times (300750) has repurchased 6.641 million A-shares at a total cost of 1.551 billion yuan [11][12] Group 9: Lixun Precision - Lixun Precision (002475) is planning to issue H shares and list on the Hong Kong Stock Exchange [13] Group 10: Ruikang Pharmaceutical - Ruikang Pharmaceutical (002589) announced that its vice president has been placed under detention by the local supervisory committee [14] Group 11: Changchun High-tech - Changchun High-tech (000661) announced that its subsidiary has received approval for a new drug, a monoclonal antibody for gout treatment [15] Group 12: Guofang Group - Guofang Group (002708) plans to reduce its holdings by up to 1.45% of the company's shares, totaling 666 million shares [16] Group 13: Guangyang Co., Ltd. - Guangyang Co., Ltd. (002708) announced that shareholders plan to reduce their holdings by up to 1.65% of the company's shares, totaling 922.76 million shares [17] Group 14: Zhixin Precision - Zhixin Precision (301512) disclosed that a major shareholder plans to reduce holdings by up to 1.86% of the company's shares, totaling 99 million shares [18] Group 15: Xinzhou Bang - Xinzhou Bang (300037) announced that its directors and executives plan to reduce their holdings by up to 126.88 million shares [19] Group 16: Guoanda - Guoanda (300902) announced that its actual controllers plan to reduce their holdings by up to 362 million shares [20]

Group 1 - The National Vaccine and Biotechnology Index (980015) has seen a strong increase of 1.48% as of July 3, 2025, with key stocks such as ZhiHua Cell (688520) rising by 19.99% and Changchun High-tech (000661) by 8.34% [1] - Changchun High-tech announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the injection of Fuxin Qibai monoclonal antibody, which is the first IL-1 inhibitor approved in China for treating acute gouty arthritis [1] - The drug shows rapid efficacy within 6 hours, comparable pain relief to steroids within 72 hours, and a nearly 90% reduction in the risk of first recurrence within 6 months, indicating a promising new treatment option for gout patients [1] Group 2 - Since the beginning of the year, the innovative drug sector has gained significant market attention due to policies, overseas expansion, and performance, although a slight adjustment has occurred recently due to accumulated gains [2] - The upcoming negotiations for the new round of medical insurance directory and the announcement of commercial insurance innovative drug directories are expected to catalyze further developments in the innovative drug sector, which remains a key investment theme [2] - The rapid development of artificial intelligence technology is anticipated to greatly benefit the pharmaceutical industry, particularly in drug development, auxiliary diagnosis, and service applications [2] Group 3 - As of June 30, 2025, the top ten weighted stocks in the National Vaccine and Biotechnology Index (980015) include Fosun Pharma (600196), Changchun High-tech (000661), and others, collectively accounting for 64.83% of the index [3]

Policy Developments - The National Healthcare Security Administration (NHSA) is soliciting public opinions on the draft adjustment plan for the 2025 National Basic Medical Insurance, Maternity Insurance, and Work Injury Insurance drug catalog, as well as the commercial health insurance innovative drug catalog [2] - The first version of the commercial health insurance innovative drug catalog will be established in 2025, focusing on innovative drugs with high clinical value that cannot be included in the basic catalog [2] Drug and Device Approvals - JinSai Pharmaceutical's monoclonal antibody drug, Firsekibart, has been approved for the treatment of acute gouty arthritis in adults who are intolerant to or have contraindications for non-steroidal anti-inflammatory drugs and/or colchicine [4] - Betta Pharmaceuticals' innovative drug, Tazemetostat, has been approved for the treatment of locally advanced or metastatic breast cancer in adults who have progressed after endocrine therapy [5] - Xiansheng Pharmaceutical's monoclonal antibody, Suweisitabant, has been approved for the treatment of recurrent ovarian cancer, fallopian tube cancer, or primary peritoneal cancer in adults who have received no more than one prior systemic therapy [6] Capital Markets - Merida Biosciences, a U.S. biotech company, has raised $121 million in Series A financing, setting a record for Series A funding in the autoimmune field [8] Industry Events - Former Takeda China President, Dan Guohong, will join BeiGene as General Manager for Greater China, Central Asia, and South Asia, starting August 18, 2025 [10] - Yuan Dong Bio's independent director, Peng Long, is under disciplinary review and investigation for serious violations of discipline and law [12] - KangLe WeiShi announced that its shareholder, Tianlangxing Holdings Group, has reduced its holdings by 1.6953 million shares, accounting for 0.6034% of the company's total share capital [13]

Core Viewpoint - Changchun High-tech's subsidiary, Jinsai Pharmaceutical, has received approval from the National Medical Products Administration for the injection of Fushen Qibai monoclonal antibody (trade name: Jinbeixin), which is indicated for acute attacks of gouty arthritis in adults who are intolerant to or have contraindications for non-steroidal anti-inflammatory drugs and/or colchicine, as well as those unsuitable for repeated use of steroid hormones [1] Group 1 - The newly developed Fushen Qibai monoclonal antibody is a fully human anti-IL-1β monoclonal antibody that specifically binds to human IL-1β, blocking the production of inflammatory mediators induced by IL-1β [1] - Key clinical trial results indicate that Fushen Qibai can take effect within 6 hours, with pain relief comparable to steroids at 72 hours, and a nearly 90% reduction in the risk of first recurrence within 6 months, demonstrating good safety [1] - The approval of this product is expected to enrich the company's product portfolio in the adult autoimmune field and enhance its competitiveness in the pharmaceutical market [1]

Core Viewpoint - The leading companies in the growth hormone sector, Changchun High-tech and Anke Bio, are facing declining revenues and are seeking new growth avenues through diversification into other therapeutic areas [1][2][3]. Group 1: Company Performance - Both Changchun High-tech and Anke Bio reported a decline in revenue and net profit for 2024, with Changchun High-tech experiencing its first annual revenue drop in nearly 20 years, showing a 5.66% decrease in revenue and a 44.95% drop in net profit for Q1 2025 [2][3]. - Anke Bio's revenue and net profit also fell by over 10% in the previous year, with a 4% decline in both metrics for Q1 2025 [2][3]. Group 2: Market Dynamics - The growth hormone market in China has expanded significantly, from $600 million in 2018 to $1.7 billion in 2022, capturing 34% of the global market share, surpassing the United States [2]. - The introduction of price-cutting measures in 2022 has pressured the revenues of the two leading companies, leading to a contraction in their growth hormone business [2][3]. Group 3: Product Development and Diversification - Changchun High-tech and Anke Bio are both attempting to diversify their product lines beyond growth hormones, with Changchun High-tech planning to expand into pediatrics, women's health, and anti-aging sectors [4][5]. - Changchun High-tech's subsidiary, GenSci, has seen over 76% of its revenue coming from growth hormones, while Anke Bio's growth hormone sales account for nearly 70% of its total revenue [3]. - Both companies have initiated clinical trials for new products, with Changchun High-tech focusing on innovative drugs and Anke Bio expanding into antiviral and oncology treatments [5].