Semaglutide Demonstrates Superior Cardiovascular Benefits Over Tirzepatide; GENESEQPRIME® Pan-Cancer 425-Gene NGS Panel Receives FDA Approval
Haisco
New Drug Research and Development, Production, and Sales
Hansoh Pharma
Pharmaceutical Research, Production, and Sales
Amino Observation - Original Production by the Innovative Drug Team
Author | Huang Kai
Another milestone has been established in the field of precision oncology in China.
On August 30, the high-throughput NGS large Panel genetic testing kit for pan-solid tumors, GENESeeqPrime® (Shihao No. 1), independently developed by Shihao Gene, was officially approved by the FDA for marketing. This follows the approval of the Shihao No. 1 large Panel TMB kit through the National Medical Products Administration's special approval channel for innovative medical devices in October 2023, marking another recognition of Shihao Gene’s technology by authoritative regulatory agencies.
Latest Results of the Semaglutide STEER Real-World Study Announced.
On August 31, Novo Nordisk presented the real-world data from the STEER study at the 2025 European Society of Cardiology (ESC) Congress held in Madrid, Spain. This evidence was collected from actual patient experiences. The STEER study investigated the risk of major adverse cardiovascular events (MACE) in patients with overweight or obesity and established cardiovascular disease but without diabetes, comparing treatment with Wegovy (semaglutide 2.4 mg) to treatment with tirzepatide.
Compared with Tirzepatide, Wegovy showed a significant advantage in reducing the risk of heart attack, stroke, cardiovascular death, or all-cause mortality among overweight or obese patients with cardiovascular disease whose treatment interruption did not exceed 30 days, with a risk reduction 57% higher.
In the past day, what hot topics in the pharmaceutical markets at home and abroad are worth paying attention to? Let Amino take you to explore.
/ 01 /
Capital Information
1) Fukang (Shanghai) Health Technology Co., Ltd. Submits IPO Application
On August 31, the Hong Kong Stock Exchange website showed that Fukang (Shanghai) Health Technology Co., Ltd. submitted its listing application. Founded in November 2015, Fukang Bio focuses on developing breakthrough therapies in the field of cancer-related disease treatment while also advancing the development and commercialization of innovative drugs targeting viral and age-related diseases. The company stated that it adopts a dual-track strategy emphasizing both commercialization and clinical development rather than solely focusing on research and development.
/ 02 /
Pharmaceutical News
1) Haisco HSK47977 Tablets Receive FDA Approval for Clinical Trials
On September 1, Haisco announced that the company had recently received the Study May Proceed Letter from the FDA, approving the clinical trial of HSK47977 tablets. HSK47977 tablets are an orally administered BCL6 PROTAC small molecule formulation independently developed by Haisco, intended for the treatment of lymphoma. Additionally, the drug received clinical trial approval from the National Medical Products Administration in August and has completed the enrollment of the first subject.
2) Hansoh Pharma's Inebilizumab Approved for New Indication
On September 1, according to the NMPA website, Inebilizumab, developed by Changzhou Hengbang Pharmaceuticals, a subsidiary of Hansoh Pharma, was approved for a new indication to treat adult patients with Immunoglobulin G4-Related Disease (IgG4-RD). Inebilizumab is the world's first approved drug for the treatment of IgG4-RD.
/ 03 /
Medical Device Daily
1) Shihedex® 425-Gene Pan-Solid Tumor Kit Receives FDA Approval for Market Launch
On August 30, the high-throughput sequencing NGS large Panel genetic testing kit for pan-solid tumors, GENESeeqPrime® (GENESEEQPRIME®), independently developed by Geneseeq, was officially approved for marketing by the FDA. This follows the approval of the GENESeeqPrime® large Panel TMB kit through the National Medical Products Administration's special approval channel for innovative medical devices in October 2023, marking another milestone in China's precision oncology field as Geneseeq’s technology gains recognition from authoritative regulatory bodies once again.
/ 04 /
Overseas Pharmaceutical News
1) STEER Real-World Study: Semaglutide Shows Superior Cardiovascular Benefits Over Tirzepatide, Risk Reduced by 57%
On August 31, Novo Nordisk presented the data from the STEER real-world study at the 2025 European Society of Cardiology (ESC) Congress held in Madrid, Spain. This evidence was collected from actual patient experiences. The STEER study investigated the risk of major adverse cardiovascular events (MACE) in patients with overweight or obesity and established cardiovascular disease but without diabetes, comparing treatment with Wegovy (semaglutide 2.4 mg) to treatment with tirzepatide.
Compared with Tirzepatide, Wegovy demonstrated a significant advantage in reducing the risk of heart attack, stroke, cardiovascular death, or all-cause mortality among overweight or obese patients with cardiovascular disease whose treatment interruption did not exceed 30 days, with a risk reduction 57% higher.
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