Summary of Sino Biopharmaceutical Conference Call Company Overview - **Company**: Sino Biopharmaceutical (1177.HK) - **Industry**: Pharmaceuticals, specifically focusing on oncology treatments Key Points and Arguments Clinical Efficacy - **Anlotinib and Benmelstobart Combination**: Demonstrated superior efficacy in first-line (1L) non-small cell lung cancer (NSCLC) without brain or liver metastasis compared to current standard of care (SoC) treatments - **PFS Comparison**: Anlotinib/benmelstobart combination showed a progression-free survival (PFS) of 11.0 months versus 7.1 months for Keytruda (HR=0.70) [2] - **Squamous Subtype**: Stronger PFS benefits observed in squamous subtype (HR=0.63) compared to non-squamous (HR=0.83) [2] - **Sequential Treatment**: In patients with wild-type NSCLC, the combination of benmelstobart plus chemotherapy followed by anlotinib resulted in longer PFS (10.12 months) compared to tislelizumab plus chemotherapy (7.79 months, HR=0.64) [2] Safety Concerns - **Adverse Events**: Notable safety concerns with the anlotinib/benmelstobart combination, particularly VEGF-related adverse events - **Hemoptysis**: 21.3% vs 3.4% for Keytruda - **Hypertension**: 51.1% vs 14.2% for Keytruda [2] Market Potential and Innovative Assets - **Emerging Assets**: Focus on innovative assets with global potential - **TQ05105**: First-in-class JAK/ROCK inhibitor for myelofibrosis and GVHD, currently in phase 3 trials - **TQC3721**: PDE3/4 inhibitor showing preliminary efficacy for COPD - **TQB2102**: HER2 bispecific ADC with anti-tumor effects in various solid tumors [2] Financial Outlook - **Price Target**: Buy-rated with a 12-month sum-of-the-parts (SOTP) based target price of HK$3.92 - **Valuation Breakdown**: Innovative pipeline valued at HK$41.5 billion and generics at HK$32.1 billion [7] - **Revenue Projections**: Expected revenue growth from Rmb 28.87 billion in 2024 to Rmb 37.42 billion by 2027 [10] Risks - **Key Risks**: - Broader price cuts on generics portfolio - Delays in regulatory approval for key products - Low return on R&D investment due to resource allocation issues - Below-expectation ramp-up of innovative drugs [7] Additional Important Information - **Market Capitalization**: Approximately HK$83.0 billion (US$10.6 billion) [10] - **Enterprise Value**: HK$92.1 billion (US$11.7 billion) [10] - **Analyst Contact Information**: Ziyi Chen and Honglin Yan from Goldman Sachs [4] This summary encapsulates the critical insights from the conference call regarding Sino Biopharmaceutical's clinical advancements, market positioning, financial outlook, and associated risks.

Core Insights - China Biologic Products (01177.HK) announced the latest results of a Phase III clinical study for Bemesumab injection combined with or without Anlotinib capsules for the treatment of unresectable stage III non-small cell lung cancer (NSCLC) at the 2025 ASCO annual meeting [1][3] Group 1: Clinical Study Results - The study (R-ALPS) demonstrated that the combination of Bemesumab and Anlotinib significantly extended the median progression-free survival (PFS) to 15.1 months compared to 4.2 months in the placebo group, reducing the risk of disease progression or death by 51% [1][2] - A total of 553 patients were randomized in the study, with 209 in the treatment group receiving Bemesumab and Anlotinib, 212 receiving Bemesumab and placebo, and 132 in the control group receiving placebo, with a median follow-up of 19.4 months [1][2] Group 2: Safety Profile - The safety profile of the treatment was consistent with known risks, with no new safety signals reported; the incidence of grade 3 or higher treatment-related adverse events was 48.8%, 29.4%, and 19.7% for the three groups respectively [2] Group 3: Industry Context - Lung cancer has the highest incidence and mortality rates among all malignancies globally, with 2.48 million new cases reported in 2022, of which 1.061 million were in China; NSCLC accounts for approximately 80%-85% of all lung cancer cases [2] - The R-ALPS study is the first of its kind in the field of combined therapy following concurrent or sequential chemoradiotherapy for unresectable stage III NSCLC, potentially reshaping clinical practice guidelines and benefiting more NSCLC patients [3]

Group 1 - HSBC raised the target price for China Biologic Products (01177.HK) by 34%, from HKD 3.8 to HKD 5.1, while maintaining a "Buy" rating [1] - The company is expected to see adjusted net profit forecasts increased by 39% and 45% for 2025 and 2026, respectively, due to encouraging data presented at the 2025 ASCO conference [1] - The outlook for the company's ability to achieve double-digit profit growth from 2025 to 2027 is optimistic, driven by faster-than-expected sales growth of PD-L1 and G-CSF, new drug launches, and improved operational efficiency [1] Group 2 - The company's stock price has increased by 36% year-to-date, reflecting positive market sentiment [1] - The industry is undergoing multiple commercial developments, contributing to improved sentiment within the sector [1] - The current valuation of the company is considered attractive given the industry's positive outlook [1]

Core Viewpoint - China Biopharmaceutical announced the latest results of a Phase III clinical study comparing Bemesumab injection combined with Anlotinib capsules to Pembrolizumab injection for first-line treatment of PD-L1 positive advanced non-small cell lung cancer (NSCLC), achieving the primary endpoint of progression-free survival (PFS) [1][2]. Group 1: Clinical Study Results - The CAMPASS study included 531 PD-L1 positive (TPS≥1%) patients with locally advanced (IIIB/C) or recurrent/metastatic NSCLC, randomized in a 2:1 ratio to receive either Bemesumab combined with Anlotinib or Pembrolizumab combined with placebo [1]. - In the overall population, the median PFS for the Bemesumab and Anlotinib group was 11.0 months, an increase of 3.9 months compared to the Pembrolizumab group (7.1 months), with a 30% reduction in the risk of disease progression/death (HR=0.70) [2]. - In the subgroup with TPS≥50%, the median PFS for the Bemesumab and Anlotinib group was extended by 6.1 months compared to the Pembrolizumab group, with a 40% reduction in the risk of disease progression/death (HR=0.60) [2]. Group 2: Safety and Tolerability - The common treatment-related adverse events in the Bemesumab and Anlotinib group were consistent with those seen in multi-targeted anti-angiogenic tyrosine kinase inhibitors (TKIs) or immunotherapy, with no new safety signals observed [3]. - Despite the extended median treatment duration due to efficacy advantages, tolerability was not significantly affected, with the rate of treatment discontinuation due to adverse events being 7.1%, lower than the Pembrolizumab group (8.0%) [3]. - The study is the first global Phase III clinical trial of an anti-PD-L1 monoclonal antibody combined with multi-targeted anti-angiogenic TKI for first-line treatment of PD-L1 positive advanced NSCLC, highlighting its significant clinical value [3].

Core Insights - A new Chinese innovative drug combination, "Defu Combination," has outperformed the global leader, Pembrolizumab (K drug), in treating PD-L1 positive advanced non-small cell lung cancer (NSCLC) [2][3] - The results were presented at the 2025 American Society of Clinical Oncology (ASCO) annual meeting, showcasing significant improvements in median progression-free survival (PFS) [2][4] Company Insights - China National Pharmaceutical Group (HK01177) reported that the "Defu Combination" achieved a median PFS of 11 months, surpassing K drug by 3.9 months, with a 30% reduction in the risk of disease progression or death [4] - The "Defu Combination" consists of two first-class innovative drugs: Anlotinib, a multi-targeted anti-angiogenic TKI approved in May 2018, and Bemarituzumab, a PD-L1 monoclonal antibody approved in May 2024 [3][4] Industry Insights - The CAMPASS study, a randomized controlled phase III trial, included 531 PD-L1 positive patients and demonstrated that the "Defu Combination" significantly benefits nearly all subgroups, especially those with high PD-L1 expression (TPS≥50%) [3][4] - The trend of increasing head-to-head clinical trials in China is notable, with domestic companies challenging established drugs like K drug, indicating a competitive landscape for innovative therapies [5][6] - The number of head-to-head trials initiated by domestic companies has risen from 2 in 2020 to 8 in 2023, reflecting a growing commitment to developing competitive treatments [6]

Core Viewpoint - China Biologic Products (01177.HK) announced preliminary data from a Phase II clinical study of TQB2868, a PD-1/TGF-β dual-function fusion protein, in combination with Anlotinib and AG chemotherapy for first-line treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC) at the 2025 ASCO annual meeting [1][2] Group 1: Clinical Study Results - The TQB2868-ALTN-II-01 study evaluated the efficacy and safety of TQB2868 combined with Anlotinib and AG chemotherapy (Gemcitabine + Albumin-bound Paclitaxel) in mPDAC patients [1] - As of January 2025, 40 patients with stage IV mPDAC were enrolled, with 36 being evaluable; the objective response rate (ORR) was 63.9%, significantly higher than the historical data for AG chemotherapy (23%-36%) [1] - The disease control rate (DCR) reached 100%, compared to 62.3% for AG chemotherapy, and the 6-month progression-free survival (PFS) rate was 86%, double that of AG chemotherapy (43.2%) [1] - The median overall survival (OS) has not yet been reached, but it is expected to exceed one year [1] Group 2: Safety Profile - The safety profile of the TQB2868 combination therapy was favorable, with a rate of grade 3 or higher adverse reactions at 52.5%, lower than the 68.1%-77% range reported for AG chemotherapy [1] Group 3: Future Developments - The company is in communication with the Chinese National Medical Products Administration (NMPA) regarding the registration of a Phase III clinical trial for the TQB2868 combination therapy [2] - This combination therapy is anticipated to become the first-line treatment for pancreatic cancer using immune checkpoint inhibitors, potentially leading to significant improvements in overall survival and quality of life for patients [2]

Core Viewpoint - The company announced preliminary data from a Phase II clinical study of TQB2868, a PD-1/TGF-β dual-function fusion protein, in combination with Anlotinib and chemotherapy for first-line treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC) at the 2025 ASCO annual meeting [1] Group 1: Clinical Study Results - The study has enrolled 40 patients with stage IV mPDAC, with 36 patients being evaluable as of January 2025 [1] - The objective response rate (ORR) for TQB2868 combined with Anlotinib and AG chemotherapy reached 63.9%, which is 2-3 times higher than historical data for AG chemotherapy [1] - The disease control rate (DCR) was 100%, 1.6 times higher than that of AG chemotherapy [1] - The median progression-free survival (PFS) has not yet been reached, but the 6-month PFS rate is 86%, which is double that of AG chemotherapy [1] - The median overall survival (OS) has not yet been reached, but it is expected to exceed one year [1] Group 2: Safety Profile - The combination therapy demonstrated good safety and tolerability, with a rate of grade 3 or higher adverse reactions at 52.5% [1] - The company is in communication with the Center for Drug Evaluation (CDE) of the National Medical Products Administration regarding the registration of a Phase III clinical trial for the TQB2868 combination therapy [1]

Core Insights - China Biologic Products (01177.HK) announced preliminary data from the first human Phase I clinical study of TQB2102, a HER2 bispecific antibody-drug conjugate (ADC), presented at the 2025 American Society of Clinical Oncology (ASCO) annual meeting [1] Efficacy Summary - The trial included 181 patients with advanced solid tumors who had no standard treatment options as of October 1, 2024, including both HER2-positive and HER2 low-expressing patients [1] - In terms of efficacy, the objective response rate (ORR) for HER2-positive breast cancer in the 6mg/kg and above dose group was 51.3%, while for HER2 low-expressing breast cancer, the ORR was 51.5% [1] - The ORR for HER2 high-expressing (HER2 IHC 3+) colorectal cancer was 34.8%, and for HER2-positive gastric or gastroesophageal junction adenocarcinoma, the ORR was 70% [1] - Among the subgroup of HER2-positive breast cancer patients with brain metastases, the ORR was 70%, with one case achieving complete resolution of intracranial lesions [1] - 31% of breast cancer patients who were resistant to T-DM1/DS-8201 still responded to TQB2102 treatment [1] Safety Summary - In terms of safety, the main ≥3 grade adverse events (AE) in the overall population included neutropenia (21.7%), decreased white blood cell count (10.6%), anemia (8.9%), and decreased platelet count (6.1%) [2] - Notably, only one case (0.55%) of grade 2 interstitial lung disease (ILD) was reported, which is significantly lower than the incidence seen with similar drug DS-8201 (greater than 10%) [2] - TQB2102 has shown significant clinical benefits across multiple advanced malignancies while maintaining a low incidence of ILD, achieving a balance between efficacy and safety [2] - Currently, TQB2102 is undergoing Phase III clinical trials and has the potential to reshape the treatment landscape for HER2 ADCs [2]

Core Viewpoint - China Biologic Products (01177) announced positive results from a Phase III clinical trial comparing Bemesumab injection combined with chemotherapy and Anlotinib hydrochloride capsules against Tislelizumab injection combined with chemotherapy for first-line treatment of advanced squamous non-small cell lung cancer (sq-NSCLC) [1][2] Group 1: Clinical Trial Results - The trial involved 565 patients randomly assigned to treatment and control groups, showing a median progression-free survival (mPFS) of 10.12 months for the trial group compared to 7.79 months for the control group, resulting in a 36% reduction in disease progression risk [2] - The objective response rates (ORR) were 71.9% for the trial group and 65.1% for the control group, with a median duration of response (DoR) of 9.69 months versus 8.34 months, indicating a significant improvement in the trial group [2] - Subgroup analysis revealed benefits across nearly all subgroups, particularly in the PD-L1 expression 1-49% population, with a hazard ratio (HR) of 0.47 [2] Group 2: Clinical Significance - The study addresses unmet clinical needs, as lung cancer has the highest incidence and mortality rates globally, with sq-NSCLC accounting for approximately 30% of all NSCLC cases [3] - The innovative treatment regimen may change existing treatment paradigms for advanced sq-NSCLC patients, who have limited options due to low mutation rates for targeted therapies [3] - The company aims to leverage its innovation and commercialization capabilities to accelerate the global market entry of this product, benefiting more patients [3]

Group 1 - The core finding of the ASCO annual meeting is the announcement of the phase III clinical trial data for the "Defu Combination" (Bemarituzumab + Anlotinib) as a first-line treatment for locally advanced or metastatic squamous non-small cell lung cancer (sq-NSCLC), showing a median progression-free survival (PFS) of 10.12 months, outperforming the comparative drug [1] - This study represents the first positive phase III clinical research result comparing immune checkpoint (PD-1) inhibitors combined with chemotherapy for the first-line treatment of squamous non-small cell lung cancer [1] - The innovative clinical trial design involved sequential treatment with Bemarituzumab combined with chemotherapy followed by Bemarituzumab combined with Anlotinib, breaking through traditional treatment standards [1] Group 2 - Based on the clinical research results, the company has submitted a new indication application for the "Defu Combination," which was accepted by the National Medical Products Administration (NMPA) on April 22 [2] - Anlotinib has already been approved for 8 indications, with 5 more in the NDA stage, while the "Defu Combination" has received approval for 3 indications and has 3 more in the new drug application stage [2] - The ASCO annual meeting is a highly regarded event in the clinical oncology field, serving as an industry benchmark, with over 70 original research projects from Chinese researchers selected for oral presentations this year, including many "First in Class" and "Best in Class" studies [2]