Core Viewpoint - Heng Rui Medicine's subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., has received a "Notice of Acceptance" from the National Medical Products Administration for the new indication application of SHR-A1811, an injection for treating locally advanced or metastatic HER2-positive breast cancer in adults who have previously received one or more anti-HER2 therapies. The application has been included in the priority review process [1] Company Summary - Heng Rui Medicine's subsidiary has made progress in the development of SHR-A1811, which targets a specific patient population with HER2-positive breast cancer [1] - The acceptance of the new indication application signifies a potential expansion of the company's product offerings in the oncology market [1] - The inclusion in the priority review process may expedite the approval timeline, enhancing the company's competitive position in the biopharmaceutical sector [1]

Market Overview - The Shanghai Composite Index rose by 0.37% on September 17, with 20 industries experiencing gains, led by the power equipment and automotive sectors, which increased by 2.55% and 2.05% respectively [1] - Conversely, the agriculture, forestry, animal husbandry, and fishery sectors, along with retail, saw declines of 1.02% and 0.98% respectively [1] - The pharmaceutical and biotechnology sector fell by 0.23% [1] Capital Flow Analysis - The main capital outflow from the two markets totaled 38.306 billion yuan, with five industries seeing net inflows [1] - The power equipment sector led the net inflow with 1.835 billion yuan, followed by the automotive sector with 1.142 billion yuan [1] - The non-bank financial sector experienced the largest net outflow, totaling 5.229 billion yuan, followed by the computer sector with a net outflow of 4.455 billion yuan [1] Pharmaceutical and Biotechnology Sector - The pharmaceutical and biotechnology sector saw a net outflow of 3.977 billion yuan, with 474 stocks in the sector; 135 stocks rose while 327 fell [2] - The top net inflow stocks included WuXi AppTec with 352 million yuan, followed by Hengrui Medicine and Boteng Co., with inflows of 312 million yuan and 55.426 million yuan respectively [2] - Nine stocks in the sector experienced net outflows exceeding 100 million yuan, with the largest outflows from Guangsheng Tang, Sino Medical, and Ganli Pharmaceutical, amounting to 253 million yuan, 164 million yuan, and 140 million yuan respectively [2] Top Gainers in Pharmaceutical Sector - WuXi AppTec: +2.09%, turnover rate 2.01%, net inflow 351.585 million yuan [2] - Hengrui Medicine: +1.42%, turnover rate 0.92%, net inflow 312.024 million yuan [2] - Boteng Co.: -0.93%, turnover rate 6.09%, net inflow 55.426 million yuan [2] Top Losers in Pharmaceutical Sector - Guangsheng Tang: -4.40%, turnover rate 9.74%, net outflow -252.737 million yuan [3] - Sino Medical: -1.74%, turnover rate 5.85%, net outflow -164.152 million yuan [3] - Ganli Pharmaceutical: -1.74%, turnover rate 2.88%, net outflow -139.861 million yuan [3]

Group 1 - The chemical pharmaceutical sector experienced a decline of 0.2% on September 17, with Warner Pharmaceuticals leading the drop [1] - The Shanghai Composite Index closed at 3876.34, up 0.37%, while the Shenzhen Component Index closed at 13215.46, up 1.16% [1] - Notable gainers in the chemical pharmaceutical sector included ST Tian Sheng, which rose by 4.97% to a closing price of 5.28, and Bai Li Tian Heng, which increased by 4.08% to 372.00 [1] Group 2 - Warner Pharmaceuticals saw a significant decline of 9.22%, closing at 57.92, contributing to the overall downturn in the sector [2] - Other notable decliners included Anglikang, down 4.53% to 41.28, and Guangsheng Tang, down 4.40% to 111.91 [2] - The sector experienced a net outflow of 1.541 billion yuan from major funds, while retail investors saw a net inflow of 1.516 billion yuan [2][3] Group 3 - Major fund inflows were observed in companies like Heng Rui Pharmaceutical, which had a net inflow of 3.43 million yuan, while retail investors showed a net outflow of 58.13 million yuan [3] - The top net inflows from retail investors were seen in Hai Zheng Pharmaceutical, with 34.03 million yuan, and Hua Yuan Biological, with 30.05 million yuan [3] - The overall trend indicates a shift in investment dynamics within the chemical pharmaceutical sector, with retail investors showing resilience despite major fund outflows [3]

Core Viewpoint - Heng Rui Medicine's subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., has received a "Notice of Acceptance" from the National Medical Products Administration for the new indication of SHR-A1811, a drug for treating HER2-positive breast cancer in patients who have previously received one or more anti-HER2 therapies [1] Group 1 - The drug SHR-A1811 is now accepted for a new indication to treat locally advanced or metastatic HER2-positive adult breast cancer patients [1] - The application has been included in the priority review process by the National Medical Products Administration [1] - SHR-A1811 is already approved in China for treating non-small cell lung cancer (NSCLC) patients with HER2 activation mutations who have received at least one systemic therapy [1]

Core Viewpoint - Heng Rui Medicine announced that its subsidiary, Fujian Shengdi Pharmaceutical Co., Ltd., has had its HRS-5635 injection included in the list of proposed breakthrough therapeutic products by the National Medical Products Administration, with a public announcement period of 7 days [1] Group 1 - HRS-5635 injection is a new generation liver-targeted HBV siRNA drug independently developed by the company [1] - The phase II clinical study results indicate that HRS-5635 has the potential to improve functional cure rates for chronic hepatitis B, while also demonstrating good safety characteristics [1]

Core Viewpoint - Heng Rui Medicine announced that its subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., received a "Notice of Acceptance" from the National Medical Products Administration for the new indication application of SHR-A1811 (Injection of Rukang Qutuzumab) for the treatment of locally advanced or metastatic HER2-positive adult breast cancer patients who have previously received one or more anti-HER2 therapies. The application has been included in the priority review process [1] Group 1 - The application for SHR-A1811 has been accepted for a new indication [1] - The drug is intended for patients with locally advanced or metastatic HER2-positive breast cancer [1] - The application has been prioritized for review by the National Medical Products Administration [1]

Group 1: Key Insights on Macro Economy - In August, industrial added value and retail sales growth rates fell below expectations, with industrial added value growing by 5.2% year-on-year, and retail sales increasing by 3.4% year-on-year [6][8][9] - Fixed asset investment growth for January to August was only 0.5%, with private investment declining by 2.3% [7][9] - The report highlights the need for macro policies to stabilize growth, particularly in light of external uncertainties and domestic climate factors [6][9] Group 2: Real Estate Industry Analysis - In August, new home prices in 70 major cities fell by 0.3% month-on-month, while second-hand home prices decreased by 0.6% [10][11] - The sales area for residential properties in August was 57.44 million square meters, down 10.6% year-on-year, marking the lowest level since 2009 [17][18] - Real estate development investment in August was 672.9 billion yuan, a year-on-year decline of 19.5%, with new construction area down 20.3% [17][20] Group 3: Transportation Sector Insights - SF Holding reported a revenue of 146.858 billion yuan for the first half of 2025, a year-on-year increase of 9.26%, with net profit rising by 19.37% [25][26] - The company’s express logistics segment grew by 10.4%, while supply chain and international segments increased by 9.7% [27]

Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of three injectable drugs, indicating progress in its oncology pipeline [1] Group 1: Clinical Trial Approvals - The company's subsidiaries, Suzhou Shengdiya Biopharmaceutical Co., Ltd. and Shanghai Shengdi Medicine Co., Ltd., have been granted clinical trial approval for SHR-1826, Adebali monoclonal antibody injection, and Bevacizumab injection [1] - SHR-1826 is an antibody-drug conjugate targeting c-MET, designed to selectively bind to tumor cell surface antigens and induce cell death [1] - Adebali monoclonal antibody injection, a humanized anti-PD-L1 monoclonal antibody, aims to block the PD-1/PD-L1 pathway, reactivating the immune system's anti-tumor activity [1] Group 2: Product Development and Market Status - Adebali monoclonal antibody injection (brand name: Ailili) was approved for market in March 2023 for first-line treatment of extensive-stage small cell lung cancer in combination with carboplatin and etoposide [1] - Bevacizumab, a humanized anti-VEGF monoclonal antibody, was co-developed by domestic and foreign pharmaceutical companies and has been marketed since 2004 in the U.S. under the brand name Avastin [1] - The company's Bevacizumab injection was approved for market in June 2021, with multiple formulations currently available in China and globally [1]

Core Viewpoint - The company has received approval from the National Medical Products Administration for clinical trials of three injectable drugs, indicating progress in its oncology pipeline [1] Group 1: Drug Approvals - The company's subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., and Shanghai Shengdi Pharmaceutical Co., Ltd. have received clinical trial approval for SHR-1826, Adebali monoclonal antibody injection, and Bevacizumab injection [1] - SHR-1826 is an antibody-drug conjugate targeting c-MET, designed to selectively bind to tumor cell surface antigens and induce cell death [1] - Adebali monoclonal antibody injection, a humanized anti-PD-L1 monoclonal antibody, aims to block the PD-1/PD-L1 pathway, reactivating the immune system's anti-tumor activity [1] - Adebali monoclonal antibody injection (brand name: Ailili) was approved for market in March 2023 for first-line treatment of extensive-stage small cell lung cancer in combination with carboplatin and etoposide [1] - Bevacizumab is a humanized anti-VEGF monoclonal antibody, co-developed by Genentech and a Chinese pharmaceutical company, and has been marketed globally since its approval in the U.S. in 2004 [1] - The company's Bevacizumab injection was approved for market in June 2021, with multiple formulations currently available in China [1]

Core Viewpoint - Heng Rui Medicine (600276) has announced a 2025 A-share employee stock ownership plan aimed at establishing a profit-sharing mechanism among the company, shareholders, and employees to enhance employee motivation, creativity, cohesion, and overall competitiveness, thereby promoting the company's long-term and sustainable development [1] Summary by Relevant Sections - The employee stock ownership plan involves the repurchase of up to 14 million A-shares, accounting for approximately 0.21% of the company's total share capital as of the announcement date [1] - The repurchase price is set at 30.95 yuan per share, with the final number of shares held under the plan to be determined based on actual execution [1] - The total number of employees participating in the plan is expected to be no more than 1,316 (excluding reserved shares), with a maximum of 9 individuals from the board (excluding independent directors), supervisors, and senior management [1]