Core Viewpoint - China Biopharmaceutical (01177) has announced that its self-developed national class 1 new drug TQ-B3234 capsule, a selective MEK1/2 inhibitor, has been included in the Breakthrough Therapy Designation (BTD) program by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for the treatment of symptomatic, unresectable neurofibromatosis type I (NF1) related adult plexiform neurofibromas [1] Group 1 - TQ-B3234 is a selective MEK1/2 inhibitor that targets the upstream regulatory factor of the extracellular signal-regulated kinase (ERK) pathway, which can inhibit tumor growth by suppressing the activity of the RAS-regulated RAF/MEK/ERK pathway [1] - The phase III registration clinical study for TQ-B3234 in treating adult plexiform neurofibromas has been approved by the CDE, aiming to confirm its efficacy and safety in a larger patient population to fill the domestic treatment gap [1] - The inclusion of TQ-B3234 in the BTD program will accelerate the drug's market launch process, potentially benefiting more patients sooner [1]

Core Viewpoint - China National Pharmaceutical Group's TQ-B3234, a selective MEK1/2 inhibitor, has been included in the Breakthrough Therapy Designation (BTD) program by the Center for Drug Evaluation (CDE) for the treatment of symptomatic, unresectable neurofibromatosis type I (NF1) related plexiform neurofibromas in adults [1] Group 1 - TQ-B3234 is a selective MEK1/2 inhibitor that targets the RAS-regulated RAF/MEK/ERK pathway to inhibit tumor growth [1] - The Phase III registration clinical study for TQ-B3234 in treating adult plexiform neurofibromas has been approved by CDE, aiming to confirm its efficacy and safety in a larger patient population [1] - Inclusion in the BTD program will accelerate the drug's market launch process, potentially benefiting more patients sooner [1]

（於開曼群島註冊成立之有限公司） 網站：www.sinobiopharm.com （股份編號：1177） 香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性或完 整性亦不發表任何聲明，並明確表示，概不對因本公告全部或任何部份內容而產生或因倚賴該等內 容而引致的任何損失承擔任何責任。 1 NF1是由NF1基因突變引起的常染色體顯性遺傳疾病，約佔所有神經纖維瘤病的96%，在中國新生兒 中預估發病率為百萬分之五[2]，2023年9月被納入中國《第二批罕見病目錄》。其中，約30%-60%的 NF1患者會發展為PN，導致疼痛、毀容甚至惡變。目前，手術是主要治療手段，但面臨高難度和易 復發等挑戰。 根據2025年《叢狀神經纖維瘤全病程管理專家共識》，對於無法手術的患者，首選MEK抑制劑進行靶 向治療以控制疾病。MEK抑制劑已證實在兒童患者中有效並有藥物在中國獲批上市，但國內的成人 PN患者目前仍缺乏有效治療藥物，治療需求遠未得到滿足。 TQ-B3234用於治療成人PN的Ⅲ期註冊臨床研究已獲CDE批准。該研究旨在更大規模的患者群體中確 證其療效與安全性，以填補國內治療空白。此次TQ-B323 ...

Core Insights - The 2025 European Society for Medical Oncology (ESMO) annual meeting will take place in Germany from October 17 to 21, where several significant oral reports from domestic innovative pharmaceutical companies are expected to be disclosed [1] - China National Pharmaceutical Group is set to present key data on its CDK2/4/6 inhibitor, Kumosili, and HER2 dual-target ADC, TQB2102, highlighting its comprehensive coverage in the breast cancer treatment landscape [1] Industry Overview - Breast cancer is the second most common cancer globally, following lung cancer, and has the highest incidence and mortality rates among women [1] - The breast cancer market is highly competitive, particularly in the HR+/HER2- subtype, which accounts for approximately 65%-70% of all breast cancer cases [2] - The global market for CDK4/6 inhibitors is projected to approach $13 billion by 2024, with ongoing growth driven by products from Pfizer, Eli Lilly, and Novartis [2] Company Developments - Kumosili capsules, a new generation CDK2/4/6 inhibitor, are expected to receive approval for second-line treatment of HR+/HER2- locally advanced or metastatic breast cancer by the end of this year [3] - The company is also advancing its clinical trials for Kumosili in first-line and adjuvant settings, aiming for comprehensive coverage across treatment lines [3] - TQB2102, another product from China National Pharmaceutical Group, will present phase Ib clinical data for HER2-positive recurrent/metastatic breast cancer at ESMO [3] Competitive Landscape - The ADC market for HER2-positive breast cancer is evolving, with significant sales from existing products like DS-8201, which reached $3.8 billion last year and is projected to peak at $10 billion [4] - TQB2102 has been optimized in terms of target binding, toxin load, and payload compared to DS-8201, and has been recognized as a breakthrough therapy for multiple indications [4] - The company has a diverse pipeline covering various cancer types, including breast, colorectal, lung, bile duct, and gastric cancers, with several indications entering phase III clinical trials [4]

Core Viewpoint - The report from GF Securities initiates coverage on China Biopharmaceutical (01177) with a "Buy" rating, projecting EPS of 0.23, 0.26, and 0.28 CNY per share for 2025-2027, and a fair value of HKD 11.54 per share, highlighting the company's transformation from a generic drug manufacturer to an R&D-driven international pharmaceutical group [1][2]. Group 1 - The company has established a strong product matrix through self-research, mergers and acquisitions, and pipeline introductions, covering four core therapeutic areas: oncology, liver disease, respiratory system, and surgical/pain management [1][2]. - R&D investment has been increasing year-on-year from 2018 to the first half of 2025, with the R&D expense ratio rising from 9.9% to 18.1%, and R&D expenses reaching CNY 3.188 billion in the first half of 2025, with approximately 78% allocated to innovative drug development [2]. Group 2 - In the oncology field, key products include: - "Defu" combination therapy with Anlotinib, which is a flagship product, and its combination with anti-PD-(L)1 for first-line indications [2]. - HER2 dual antibody ADC TQB2102, which is leading globally and has entered Phase III for treating HER2 low-expressing and HER2-positive breast cancer [2]. - CDK2/4/6 inhibitor Kumosilib, a global first, has submitted for marketing approval for HR+/HER2- breast cancer [2]. - CCR8 monoclonal antibody LM-108, a global first, is currently in Phase II [2]. - In the respiratory field, PDE3/4 inhibitors are expected to become a blockbuster drug for COPD, with TQC3721 being in the second position globally [2]. - In the liver disease area, the pan-PPAR agonist Lanifibranor may become the first MASH drug in China, while FGF21 fusion protein could be the most effective MASH drug [2]. - In the surgical and pain management sector, the company has established four transdermal patch technology platforms, solidifying its position as a leader in transdermal formulations [2].

Core Viewpoint - GF Securities initiates coverage on China Biologic Products (01177) with a "Buy" rating, projecting EPS of 0.23, 0.26, and 0.28 CNY per share for 2025-2027, with a fair value of HKD 11.54 per share, highlighting the company's transformation from a generic drug manufacturer to an R&D-driven international pharmaceutical group [1][2] Group 1 - The company has established a strong product pipeline covering four core therapeutic areas: oncology, liver disease, respiratory system, and surgical/pain management, successfully transitioning from a generic drug company to an innovative pharmaceutical leader [1][2] - R&D investment has been increasing annually from 2018 to H1 2025, with the R&D expense ratio rising from 9.9% to 18.1%, and R&D expenses reaching CNY 3.188 billion in H1 2025, with approximately 78% allocated to innovative drug development [2] Group 2 - In the oncology field, key products include: - "DeFu" combination therapy with Anlotinib, which is a flagship product, expanding first-line indications through combination with anti-PD-(L)1 therapy, with approvals for SCLC, endometrial cancer, and renal cell carcinoma [2] - HER2 bispecific antibody ADC TQB2102, which is leading globally and is in Phase III for treating HER2 low-expressing and HER2-positive breast cancer [2] - CDK2/4/6 inhibitor Kumosi Li, the world's first of its kind, has submitted for marketing approval for HR+/HER2- breast cancer [2] - CCR8 monoclonal antibody LM-108, a global first, is currently in Phase II [2] Group 3 - In the respiratory field, PDE3/4 inhibitors are expected to become a blockbuster drug for COPD, with TQC3721 being in the second position globally [2] - In the liver disease area, the pan-PPAR agonist Lanifibranor may become the first MASH drug in China, while FGF21 fusion protein could be the most effective MASH drug [2] - In the surgical and pain management sector, the company has established four transdermal patch technology platforms, solidifying its position as a leader in transdermal formulations [2]

Core Insights - China Biopharmaceutical presented positive Phase II clinical results for its PDE3/4 inhibitor TQC3721 at the European Respiratory Society 2025 conference, showing rapid improvement in lung function and symptoms for COPD patients [1][2] Group 1: Clinical Results - TQC3721 demonstrated significant improvements in FEV1 peak values compared to the placebo group, with increases of 100ml and 147ml for the 3mg and 6mg groups respectively after 4 weeks of treatment [1] - In the subgroup of patients using LAMA and LABA/LAMA, the 6mg group showed a FEV1 peak increase of 239ml compared to the placebo group [1] - The safety profile of TQC3721 was favorable, with no significant adverse effects observed in gastrointestinal, cardiovascular, or liver and kidney functions during the clinical trial [1] Group 2: Comparative Analysis - TQC3721's clinical data suggests it has best-in-class potential, with the 6mg group showing FEV1 peak values consistent with those of the recently approved drug ensifentrine [2] - The baseline characteristics of TQC3721 trial participants were poorer compared to those in the ensifentrine trials, indicating a greater potential for clinical benefit in real-world COPD patients [2] Group 3: Market Potential - The global COPD market is substantial, with nearly 480 million affected individuals worldwide, and over 100 million in China, making it a significant health and economic burden [3] - The recent acquisition of Verona by Merck for $10 billion highlights the market potential for PDE3/4 inhibitors, with ensifentrine's sales showing strong growth [3] - TQC3721, being the second globally in development and the only PDE3/4 inhibitor in Phase III trials, is positioned for significant overseas licensing opportunities [3]

Core Insights - The pharmaceutical index increased by 0.36% from September 29 to October 10, underperforming the CSI 300 index by -1.11% [1] - The "Most-Favored-Nation Pricing" agreement catalyzed significant stock price increases for U.S. MNCs, which also positively impacted Hong Kong's innovative drug sector, although there was a notable decline in the following trading days [1] - Anticipated catalysts in October include ESMO, BD, and medical insurance negotiations, which may stabilize and rebound innovative drug stocks [1] Market Performance - From September 29 to October 10, 316 stocks rose while 148 fell, with notable gainers including Zhendong Medical (+31.82%) and Wanbangde (+21.21%), while major losers included Nanxin Pharmaceutical (-28.67%) and ST Fuhua (-13.64%) [2] - Q3 performance expectations indicate a significant trend in innovative drug volume, with traditional pharmaceutical companies like Heng Rui expected to maintain Q2 trends [2] - Blood products and vaccines are projected to face continued pressure, while CXO and upstream research are expected to show good external demand growth [2] Investment Opportunities - The Chinese pharmaceutical industry has transitioned to new growth drivers, particularly in innovative drugs, with companies like Heng Rui and Han Sen making significant strides [3][4] - The demand for chronic disease treatments is increasing due to an aging population, supported by a stable growth in medical insurance revenue [4] - The AI wave is anticipated to unlock new growth logic in the pharmaceutical sector [4] Recommended Stocks - Current recommendations include Xintai, Rejing Bio, and China National Pharmaceutical, with a focus on companies like Heng Rui and Sanofi for October [5]

Investment Rating - The report suggests a positive outlook for the oligonucleotide drug industry, indicating that it is on the verge of a therapeutic paradigm revolution, particularly in the treatment of common diseases [3]. Core Insights - The oligonucleotide drug market is approaching a critical point of explosion, with significant advancements in delivery technologies and therapeutic targets [3]. - The report highlights the potential for multiple innovative treatment paradigms for common liver diseases over the next five years, focusing on lipid-lowering, blood pressure reduction, and hepatitis B [3]. - The report emphasizes the importance of differentiated delivery technologies and the potential for business development (BD) opportunities in the industry [3]. Summary by Sections Industry Overview - The report revisits the previous assessment from January 2021, which predicted that oligonucleotide drugs would become the third major class of therapeutics after small molecules and monoclonal antibodies [3]. - It notes that the market has seen a significant increase in the number of approved siRNA/ASO drugs since 2022, addressing unmet medical needs [4]. Market Dynamics - The report identifies key players in the industry, including Alnylam, Arrowhead, and Ionis, and discusses their market capitalization changes from 2021 to 2025, highlighting Alnylam's significant growth due to successful drug launches [7]. - It mentions that the market for oligonucleotide drugs is expanding into common diseases, with Alnylam's drugs like Amvuttra and Inclisiran showing strong sales potential [20]. Technological Advancements - The report discusses advancements in delivery technologies, particularly the GalNAc conjugation platform, which has significantly improved the efficacy and safety of oligonucleotide drugs [41][42]. - It highlights the ongoing research into dual-target oligonucleotide drugs, which may become a new trend in the industry [36]. Competitive Landscape - The report outlines the competitive landscape, noting that multinational corporations (MNCs) are actively acquiring clinical-stage FIC drugs and exploring collaborations with biotech firms [3]. - It emphasizes the need for targeted delivery systems for different organs, indicating that the advancement and differentiation of delivery platforms will be crucial for the future success of oligonucleotide drug companies [26][27].

Core Insights - China National Pharmaceutical Group's self-developed drug TQB2102 has been included in the Breakthrough Therapy Designation (BTD) program by the National Medical Products Administration (NMPA) for the treatment of HER2 IHC 3+ advanced colorectal cancer that has failed previous treatments with oxaliplatin, irinotecan, and fluorouracil [1][2] - TQB2102 is a dual-targeting antibody-drug conjugate (ADC) that targets HER2 protein ECD2 and ECD4 non-overlapping epitopes, showing significant efficacy in colorectal cancer treatment [1] - Preliminary data from the Phase I clinical trial presented at the 2025 American Society of Clinical Oncology (ASCO) annual meeting indicates an objective response rate (ORR) of 34.8% in patients with HER2 high expression (HER2 IHC 3+) [1] Industry Context - There is currently a lack of specific targeted treatment options for advanced colorectal cancer with HER2 overexpression, with existing second-line treatments showing low efficacy [2] - The objective response rate (ORR) for third-line treatment options is only 1.0%-2.0%, with progression-free survival (PFS) ranging from 1.9 to 3.7 months and overall survival (OS) between 6.4 to 7.4 months, highlighting the urgent need for effective treatment solutions [2] - The inclusion of TQB2102 in the BTD program is expected to accelerate its market entry, potentially transforming the treatment landscape for HER2 IHC 3+ colorectal cancer [2]