Core Points - The company has successfully included several of its products in the National Medical Insurance Catalog for 2025, which is expected to enhance sales and improve operational performance [1] - The total estimated sales for the included drugs in 2024 is approximately 8.66 billion yuan, and for the first three quarters of 2025, it is about 7.55 billion yuan [1] Drug Inclusion in National Medical Insurance Catalog - The following drugs have been newly included: - Injection of Rukang Qutuzumab - Apixaban Famitinib Capsules - Injection of Funaqi Zhumab - Sulfate of Amatuximab Tablets - Injection of Phosphorola Pitant Palonosetron - Injection of Ruikasi Zhumab - Acetate of Abiraterone Tablets (II) - Lipid Injection of Irinotecan Hydrochloride (II) - Regaglitin Metformin Tablets (I)/(II) - Perfluorohexyl Octane Eye Drops [1] - The following drugs have successfully added new indications: - Injection of Karelizumab - Fluorazepam Capsules - Injection of Fumaric Acid Tegafur [1] - The following drugs have been renewed and retained in the National Medical Insurance Catalog: - Maleate of Pyrotinib Tablets - Hecorapam Ethanolamine Tablets - Phosphate of Regaglitin Tablets - Injection of Methylsulfonylmethane Remazolam - Sulfate of Pevonedistat Injection [1] - The following drugs have new indications and have been adjusted to regular catalog management: - Mesylate of Apatinib Tablets - Lipid Injection of Bupivacaine [1] Impact on the Company - The inclusion of these drugs in the National Medical Insurance Catalog is expected to positively impact sales, although the exact effect on the company's operational performance is currently indeterminate [1] - The National Medical Insurance Catalog will officially take effect on January 1, 2026, with further details on payment standards and reimbursement rules to be announced by relevant government departments [1]

Core Viewpoint - Heng Rui Medicine (01276) has seen a stock price increase of nearly 3%, currently trading at 72.35 HKD, following the announcement of receiving clinical trial approval for its drug, Fumaric Acid Tegeline Injection, from the National Medical Products Administration [1] Group 1: Company Developments - On November 17, Heng Rui Medicine announced that it received the clinical trial approval notice for Fumaric Acid Tegeline Injection from the National Medical Products Administration [1] - Fumaric Acid Tegeline Injection is a μ-opioid receptor (MOR) biased small molecule agonist, set to be approved for domestic market launch in January 2024, marking it as China's first independently developed Class 1 opioid analgesic innovation drug [1] - The company has invested approximately 200 million RMB in the research and development of Fumaric Acid Tegeline Injection to date [1] Group 2: Market Context - A similar product, Oliceridine (brand name: Olinvyk), developed by Trevena, was approved for sale in the United States in 2020 [1] - Jiangsu Enhua Pharmaceutical Co., Ltd. has obtained exclusive licensing from Trevena for Oliceridine, which was approved for sale in China in May 2023, although no sales data has been reported yet [1]

Core Viewpoint - Heng Rui Medicine (600276) has seen a nearly 3% increase in stock price, currently trading at 72.35 HKD, following the announcement of clinical trial approval for its drug, Fumaric Acid Tegeline Injection, by the National Medical Products Administration of China [1] Group 1: Company Developments - On November 17, Heng Rui Medicine announced that it received the clinical trial approval notice for Fumaric Acid Tegeline Injection from the National Medical Products Administration [1] - Fumaric Acid Tegeline Injection is a μ-opioid receptor (MOR) biased small molecule agonist, set to be approved for domestic market launch in January 2024, marking it as China's first independently developed Class 1 opioid analgesic innovation drug [1] - The company has invested approximately 200 million RMB in the research and development of Fumaric Acid Tegeline Injection to date [1] Group 2: Market Context - The drug has a comparable product, Oliceridine (brand name: Olinvyk), developed by Trevena, which was approved for sale in the United States in 2020 [1] - Jiangsu Enhua Pharmaceutical Co., Ltd. has obtained exclusive licensing from Trevena for Oliceridine, which was approved for sale in China in May 2023, although no sales data has been reported yet [1]

Policy Developments - The National Medical Products Administration (NMPA) has released new guidelines to streamline the registration process for new functional cosmetics, implementing an immediate review system [1] - The guidelines encourage the launch of international cosmetic products in China without the need for overseas sales proof and support the development of products targeting the elderly population [1] Drug and Device Approvals - Heng Rui Medicine has received clinical trial approval for Fumaric Acid Teglutik Injection, which is set to be the first domestically developed Class 1 opioid analgesic in China, expected to be approved for market in January 2024 [2] - Heng Rui Medicine also announced the approval for clinical trials of HRS-6209 capsules, a selective CDK4 inhibitor for advanced solid tumors, and HRS-2189 tablets, a KAT6 inhibitor for advanced malignancies, both of which have no similar products approved domestically or internationally [3] - Fuhong Hanlin's HLX11 (Pertuzumab) has been approved by the FDA for HER2-positive breast cancer treatment, marking it as the first interchangeable biosimilar for cancer treatment approved in the U.S. [4] Capital Markets - SenseTime Medical has initiated a Series A financing round, with post-investment valuation exceeding 3 billion yuan, following a recent strategic financing round [5] - Yabao Pharmaceutical plans to sell 62% of its stake in Taiyuan Pharmaceutical for approximately 87.19 million yuan, resulting in a significant change in ownership structure [6] Industry Developments - Kangfang Biotech has received approval for clinical trials of its dual-specific antibody new drug AK152 for Alzheimer's disease, marking a significant advancement in the treatment of this condition [7][8]

Major Events - Shandong Xinhua Pharmaceutical Co., Ltd. received the approval notice for the listing application of fumaric acid vonoprazan chemical raw materials [1] - HeYue Pharmaceutical showcased long-term efficacy and safety data from the clinical III MANEUVER study of pitmiprazole at the CTOS 2025 conference [1] - China Software International partnered with Deep Open Hong and Yiswei Computing to build a new ecosystem for "open-source HarmonyOS + RISC-V" digital infrastructure [1] - China General Nuclear Power Corporation's Zhaoyuan Unit 1 is set to begin full construction [1] - Hengrui Medicine's fumaric acid teglutide injection received approval for clinical trials [1] - China National Nuclear Corporation signed an intention procurement agreement for cobalt-60 irradiation sources with the Brazilian National Nuclear Energy Commission [1] Operating Performance - China Railway Construction Corporation recently won several major projects with a total investment of 49.629 billion yuan [1] - Geely Automobile reported a net profit of 3.82 billion yuan for the third quarter, a year-on-year increase of 59% [1] - China Resources Power's subsidiary power plants achieved a cumulative electricity sales volume of 185 million megawatt-hours in the first ten months, a year-on-year increase of 6.5% [1] - Leap Motor reported a net profit of 150 million yuan for the third quarter, maintaining the top sales position among new force brands in China for eight consecutive months [1] - Huazhu Group's net profit attributable to shareholders for the third quarter was 1.5 billion yuan, a year-on-year growth of 15.4% [1] - Air China saw a year-on-year increase of 8.7% in passenger turnover in October [1] - China Eastern Airlines reported a year-on-year increase of 10.58% in passenger turnover in October [1]

Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for the clinical trial of fumaric acid tegafur injection, indicating progress in its drug development pipeline [1] Group 1 - The company announced the receipt of the clinical trial approval notice on November 17 [1] - The approval is a significant step for the company's research and development efforts in the pharmaceutical sector [1]

Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of Fumaric Acid Tegeline Injection, marking a significant step in the development of China's first independently developed Class 1 opioid analgesic [1] Group 1: Product Development - Fumaric Acid Tegeline Injection is a μ-opioid receptor (MOR) biased small molecule agonist [1] - The product is expected to be launched in China in January 2024 [1] - The company has invested approximately 200 million yuan in the research and development of this project [1] Group 2: Market Context - Oliceridine, a similar product developed by Trevena, was approved for sale in the United States in 2020 [1] - Jiangsu Enhua Pharmaceutical Co., Ltd. has obtained exclusive licensing from Trevena for Oliceridine, which was approved for sale in China in May 2023 [1] - No sales data for Oliceridine in China has been reported as of now [1]

Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for the clinical trial of Fumaric Acid Tegilide Injection, which will be conducted soon [1] Group 1: Drug Information - Drug Name: Fumaric Acid Tegilide Injection [1] - Dosage Form: Injection [1] - Application Matter: Clinical Trial [1] - Acceptance Numbers: CXHL2500912, CXHL2500913 [1] Group 2: Approval Details - Approval Conclusion: The clinical trial application for Fumaric Acid Tegilide Injection, accepted on August 28, 2025, meets the requirements for drug registration [1] - Purpose of Clinical Trial: To conduct clinical trials for pain relief in mechanically ventilated patients in intensive care [1]

Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of Fumaric Acid Tegeline Injection, aimed at providing analgesia for patients on mechanical ventilation in intensive care [1] Company Summary - Fumaric Acid Tegeline Injection is a μ-opioid receptor (MOR) biased small molecule agonist [1] - The product is set to be approved for domestic market launch in January 2024, marking it as China's first independently developed Class 1 innovative opioid analgesic [1]

Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for the clinical trial of Fumaric Acid Tegilide Injection, marking a significant step in the development of China's first independently developed class 1 opioid analgesic [1] Company Summary - Heng Rui Medicine's Fumaric Acid Tegilide Injection is a μ-opioid receptor (MOR) biased small molecule agonist, expected to be approved for domestic market launch in January 2024 [1] - The company has invested approximately 199.99 million yuan in the research and development of Fumaric Acid Tegilide Injection to date [1] Industry Summary - Fumaric Acid Tegilide Injection is positioned as a novel opioid analgesic in China, with a similar product, Oliceridine (brand name: Olinvyk), developed by Trevena, already approved in the U.S. in 2020 [1] - Jiangsu Enhua Pharmaceutical Co., Ltd. has obtained exclusive licensing from Trevena for Oliceridine, which was approved for sale in China in May 2023, although sales data is currently unavailable [1]