Core Viewpoint - The phase III clinical trial of LZM012, a recombinant human IL-17A/F humanized monoclonal antibody injection developed by Zhuhai Lizhu Biotech Co., Ltd. and Beijing Xinkanghe Biopharmaceutical Technology Co., Ltd., has achieved its primary endpoint in patients with moderate to severe plaque psoriasis [1] Group 1: Clinical Trial Results - The trial was a multicenter, randomized, double-blind, positive-controlled study comparing LZM012 to the control group, Secukinumab [1] - At week 12, the PASI 100 response rate for LZM012 was 49.5%, compared to 40.2% for Secukinumab, indicating non-inferiority and superiority of LZM012 [1] - The PASI 75 response rate at week 4 was 65.7% for LZM012 versus 50.3% for Secukinumab, demonstrating a faster onset of action for LZM012 [1] - At week 52, the PASI 100 response rates for LZM012 in the 320mg Q4W and 320mg Q8W maintenance treatment groups were 75.9% and 62.6%, respectively, showing sustained benefits for psoriasis patients [1] Group 2: Safety and Regulatory Progress - The overall safety profile of LZM012 was good, with the incidence of common adverse events comparable to that of the control group [1] - Lizhu Group has submitted a communication application to the National Medical Products Administration (NMPA) for the marketing authorization of LZM012 for the treatment of adult patients with moderate to severe plaque psoriasis, advancing the drug's approval process [1]

Core Viewpoint - Heng Rui Medicine (600276.SH) has received approval from the National Medical Products Administration for clinical trial notifications for four drugs, indicating progress in its drug development pipeline [1] Drug Development Summary - SHR-8068 Injection: A fully human anti-CTLA-4 monoclonal antibody with a development investment of approximately 214 million yuan [1] - Abediterol Injection: A self-developed humanized anti-PD-L1 monoclonal antibody with a development investment of approximately 887 million yuan [1] - Bevacizumab Injection: A humanized anti-VEGF monoclonal antibody with a development investment of approximately 345 million yuan [1] - Apatinib Mesylate Tablets: An innovative small molecule targeted drug with a development investment of approximately 587 million yuan [1] Regulatory Process Summary - Following the approval of the clinical trial notifications, the drugs must undergo clinical trials and receive further review and approval from the National Medical Products Administration before they can be manufactured and marketed [1]

Core Viewpoint - Micron Biologics announced that the final results of the key Phase III clinical trial (DEB study) for its self-developed drug, Sidabone, targeting first-line treatment of diffuse large B-cell lymphoma (DLBCL), have shown that the event-free survival (EFS) of the trial group is significantly better than that of the control group, achieving the primary endpoint of the study [1] Group 1 - Sidabone combined with R-CHOP is the first treatment regimen in the world to demonstrate a significantly higher complete response (CR) rate than R-CHOP in a Phase III clinical trial for first-line DLBCL treatment [1] - The top-line analysis indicates that the EFS in the trial group shows statistically significant differences compared to the control group, further validating that the Sidabone combination regimen can provide significant and sustainable efficacy for newly treated MYC and BCL2 double-expressing DLBCL patients, with good safety [1] - The company is preparing to submit for routine approval for this indication [1] Group 2 - A comprehensive analysis of the final results of the study will be presented at upcoming academic conferences or journals [1]

Summary of Jasper Therapeutics (JSPR) Update / Briefing July 07, 2025 Company Overview - **Company**: Jasper Therapeutics (JSPR) - **Focus**: Development of therapies for chronic spontaneous urticaria (CSU) using the drug vaprolimab Key Points Industry and Company Context - The conference call was focused on updated data from the BEACON trial and initial data from the open label extension study evaluating vaprolimab in patients with CSU [4][20] Core Findings from the BEACON Trial - **Efficacy**: - A greater than 25 drop in UAS7 (Urticaria Activity Score over 7 days) was observed in the 240 mg and 360 mg single dose cohorts, with 78% complete response and 89% well-controlled disease by week four [4][21] - In the open label extension study, 73% of patients achieved complete response and 82% well-controlled disease at the 12-week assessment with a mean reduction in UAS7 scores of greater than 25 points [17][22] - **Safety Profile**: - Vaprolimab demonstrated a favorable safety profile with no dose-limiting toxicities reported. Treatment emergent adverse events were similar in both active and placebo groups [13][22] - Mild transient adverse events were observed, including taste changes and neutrophil count reductions, but these were self-resolving and did not lead to discontinuations [14][15] Issues Identified - **Confounding Results**: - Two cohorts (240 mg Q8 weeks and 240 mg followed by 180 mg Q8 weeks) showed confounded results due to an issue with a specific drug product lot (lot A34954), which resulted in lower than expected drops in mean tryptase levels and no discernible effect on UAS7 in 10 out of 10 patients dosed with this lot [5][12] - An investigation into the affected lot is ongoing, with results expected in the coming weeks [6][20] - **Next Steps**: - Additional 10 to 12 patients will be enrolled in the affected cohorts to ensure a robust data set for the Phase IIb CSU study expected to commence mid-2026 [6][20] Financial and Operational Insights - **Cash Runway**: - Current guidance into the fourth quarter remains unchanged, but the company is evaluating its cost structure and may need to raise additional capital to extend its runway [54] - **Regulatory Communication**: - The company is in communication with the FDA regarding the lot issue, but there are no safety concerns associated with the affected lot [48][41] Additional Observations - **Durability of Responses**: - The data suggests that the depth of triptase reduction correlates with the depth of UAS7 reductions, indicating a potential for durable effects with the 180 mg dosing regimen [55] - **Patient Management**: - Patients who received the inactive dose from the compromised lot will be transitioned to a new drug product that has demonstrated efficacy in other cohorts [20][48] Conclusion - Jasper Therapeutics is optimistic about the potential of vaprolimab as a differentiated therapeutic option for CSU, despite the setback from the compromised drug lot. The company is taking proactive steps to address the issue and continue its clinical development program.

Core Viewpoint - The company ST HuLuWa (605199) has received approval from the National Medical Products Administration for clinical trials of its new product, a modified version of the existing "Pediatric Lung Heat Cough and Asthma Granules," now targeting adult influenza patients [1] Group 1: Product Development - The new product is an improvement on the already marketed "Pediatric Lung Heat Cough and Asthma Granules" [1] - The modified formulation expands its indications to include "heat toxin attacking the lung syndrome" associated with influenza in adults [1] - The product is designed to clear heat and detoxify, relieve cough, and reduce phlegm and wheezing, applicable for conditions like cold, bronchitis, wheezing bronchitis, and bronchopneumonia [1]

Group 1 - The core objective of the study is to evaluate the clinical effectiveness of self-administered selatogrel in preventing all-cause mortality and treating acute myocardial infarction (AMI) in subjects with a recent history of AMI [1] - The study is a multicenter, randomized, double-blind, placebo-controlled trial, marking the first registered global clinical trial initiated by the cardiology department of Dongying People's Hospital [1] - The kickoff meeting included detailed discussions on the research background, study design, inclusion and exclusion criteria, efficacy and safety indicators, and drug administration protocols [1] Group 2 - The successful convening of the kickoff meeting highlights the clinical research capabilities of Dongying People's Hospital in the field of cardiovascular diseases [2] - The hospital's drug clinical trial institution aims to maintain a scientific and rigorous approach, deepen domestic and international research cooperation, and promote the standardization of clinical research [2] - This initiative is expected to enhance the hospital's overall strength and influence in the cardiovascular discipline [2]

Group 1 - The 2025 Zhejiang Listed Companies Investor Online Reception Day and 2024 Annual Performance Briefing was held on May 13, 2025 [1] - East China Pharmaceutical's board secretary Chen Bo announced that the oral small molecule GLP-1 receptor agonist HDM1002 (conveglipron) completed the first subject enrollment for weight management indication in the Phase III clinical study in April 2025, with plans to complete all subject enrollments by the end of June 2025 [1] - The Phase II clinical study for diabetes indication is progressing smoothly, with topline results expected in Q3 2025 and entry into Phase III clinical research planned for the second half of 2025 [1] Group 2 - The GLP-1R/GIPR dual-target long-acting peptide agonist HDM1005 (poterepatide) is currently undergoing Phase II clinical trials for weight management indication, with all subjects enrolled by April 2025 and expected to enter Phase III clinical research in Q4 2025 [1] - The Phase II clinical trial for diabetes indication also completed the first subject enrollment in April 2025, and new indication IND applications for HDM1005 have been approved by NMPA for the treatment of obstructive sleep apnea (OSA) with obesity or overweight, and heart failure with preserved ejection fraction (HFpEF) with obesity or overweight [1] Group 3 - The FGF21R/GCGR/GLP-1R tri-target agonist DR10624 injection is currently conducting Phase II clinical research in China for the treatment of metabolic-associated fatty liver disease with high-risk liver fibrosis and metabolic-associated alcoholic fatty liver disease, with the first subject enrolled in April 2025 [2] - Another Phase II clinical study for DR10624 targeting severe hypertriglyceridemia in China has completed all patient enrollments, with topline results expected in Q3 2025 [2] - DR10624 has also received approval for clinical trial applications in China for type 2 diabetes and weight indications, and key research data for DR10624 in treating obesity with hypertriglyceridemia was presented at the EASL Congress 2025 in Amsterdam [2]

Core Insights - Trevi Therapeutics, Inc. reported positive topline results from its Phase 2b CORAL trial of Haduvio for chronic cough in patients with idiopathic pulmonary fibrosis (IPF), achieving the primary endpoint with statistically significant reductions in 24-hour cough frequency across all dose groups at week six [1][2]. Group 1: Trial Results - The 108 mg BID, 54 mg BID, and 27 mg BID dose groups achieved reductions from baseline of 60.2%, 53.4%, and 47.9%, respectively, compared to a placebo reduction of 16.9% [2]. - A rapid reduction in 24-hour cough frequency was observed at week two, with 65% of patients on 108 mg BID, 63% on 54 mg BID, and 60% on 27 mg BID experiencing a 50% reduction at week six, compared to 19% of placebo patients [5]. - Statistically significant improvements were noted in secondary endpoints for the 108 mg BID and 54 mg BID dose groups, including a mean reduction of 3.0 points for 108 mg BID and 3.2 points for 54 mg BID on the cough-severity numerical rating scale, compared to a 1.5-point reduction for placebo [5]. Group 2: Safety and Discontinuation - Discontinuation rates due to adverse events were similar between the Haduvio (5.6%) and placebo groups (5%) [4]. Group 3: Stock Performance - Following the announcement, Trevi Therapeutics' stock declined by 10.45%, trading at $5.83 [4].

Financial Performance - Karyopharm Therapeutics reported quarterly losses of $2.77 per share, which was better than the analyst consensus estimate of losses of $4.16 per share [1] - The company reported quarterly sales of $30.02 million, missing the analyst consensus estimate of $35.24 million [1] Clinical Trial Update - The Phase 3 SENTRY trial in patients with JAKi-naïve myelofibrosis has passed its pre-specified futility analysis and continues as planned without modifications [2] - New data in hard-to-treat myelofibrosis patients showed spleen volume reduction, symptom improvement, hemoglobin stabilization, and evidence of disease modification with selinexor monotherapy [2] Sales Guidance and Market Reaction - Karyopharm affirmed FY2025 sales guidance of $140.00 million to $155.00 million, compared to market estimates of $149.32 million [3] - Following the earnings announcement, Karyopharm shares fell 15.6% to trade at $5.17 [3] Analyst Ratings and Price Targets - Baird analyst Michael Ulz maintained an Outperform rating and lowered the price target from $54 to $42 [8] - Barclays analyst Peter Lawson maintained an Overweight rating and raised the price target from $5 to $10 [8] - RBC Capital analyst Brian Abrahams maintained an Outperform rating and lowered the price target from $34 to $33 [8]

Financial Data and Key Metrics Changes - Total revenue for Q1 2025 was $30 million, down from $33.1 million in Q1 2024 [46] - U.S. XPOVIO net product revenue decreased to $21.1 million from $26 million year-over-year, attributed to a $5 million increase in product return reserves [47] - Gross to net provisions for XPOVIO were 45% in Q1 2025 compared to 29.3% in the same period in 2024 [47] - Cash, cash equivalents, and investments at the end of Q1 2025 were $70.3 million, down from $109.1 million at the end of 2024 [48] Business Line Data and Key Metrics Changes - Demand growth for Q1 was 5% year-over-year, with net product revenue impacted by atypical returns of expired products [40] - Royalty revenue increased by 57% to $1.7 million in Q1 2025 compared to Q1 2024, reflecting growing global demand for XPOVIO [42] Market Data and Key Metrics Changes - The multiple myeloma market remains highly competitive, with expectations of additional new entrants this year [41] - The company anticipates a peak revenue potential of approximately $1 billion in the U.S. for selinexor in myelofibrosis if approved [10] Company Strategy and Development Direction - The company is focused on completing enrollment in the Phase III SENTRY trial for myelofibrosis and advancing the Phase III trial in endometrial cancer [7][38] - The strategy includes leveraging a profitable commercial organization in multiple myeloma to drive rapid commercialization in new disease areas [7] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of selinexor to redefine the standard of care in myelofibrosis, with encouraging clinical data supporting its efficacy [8][10] - The company is exploring various opportunities to extend its cash runway while focusing on advancing clinical trials and commercial performance [51][53] Other Important Information - The Phase III SENTRY trial successfully passed its pre-specified futility analysis, allowing the study to continue as planned [35] - The company expects to complete enrollment in the SENTRY trial by June-July 2025 [35][67] Q&A Session Summary Question: Can you talk about the futility analysis and its basis? - The futility analysis was based on efficacy and safety data from the first 61 patients, with thresholds for no worsening compared to ruxolitinib alone [55][56] Question: What are the assumptions for achieving full enrollment in June and July? - The company is currently 80% enrolled and expects to complete enrollment in the June-July timeframe, with a press release to follow [67] Question: What is driving utilization in multiple myeloma? - The company reported 5% growth in demand, with utilization driven by its flexible combination therapy positioning in both community and academic settings [82] Question: What is the normal run rate of return product? - The atypical returns of $5 million were related to high-dose products, and the company does not expect this to continue into future quarters [89] Question: How confident is the company in reaching its revenue guidance? - The company believes it can deliver at the lower end of its revenue guidance due to strong demand growth and global partner revenue [97]