Home Medtronic Invests $700 Million in Cornerstone Robotics; Akeso's Ivonescimab Achieves Positive OS Interim Analysis in HARMONi-2 Trial

Medtronic Invests $700 Million in Cornerstone Robotics; Akeso's Ivonescimab Achieves Positive OS Interim Analysis in HARMONi-2 Trial

Sep 03, 2026 19:40 CST Updated 19:40
Medtronic

Medical Device Manufacturer

Cornerstone Robotics

Innovative Surgical Robot Developer

HUTCHMED

Biopharmaceutical Manufacturer

GSK

Pharmaceutical R&D Manufacturer

AIPher

AI-Native Drug Discovery Company

Everest Medicines

Developer of Innovative Therapies

Akeso

Innovative Antibody Drug Developer

图片
Today’s key developments in the pharmaceutical industry include: Everest Medicines’ Xingbituo approved for acute episodes of paroxysmal supraventricular tachycardia (PSVT) in adults, filling a gap in out-of-hospital self-rescue medication; HUTCHMED licensed overseas rights to its KRAS-EGFR antibody-targeted conjugate HMPL-A830 to GSK, receiving an upfront payment of $110 million with potential total deal value reaching up to $1.295 billion; the National Medical Products Administration (NMPA) expanded consistency evaluation for chemical drugs to include dosage forms such as eye drops, patches, and sprays; Cornerstone Robotics secured approximately $700 million in strategic investment from Medtronic and entered into distribution partnerships for certain overseas markets; NuOshen Pharmaceuticals completed over $80 million in Series B financing; AIPher completed RMB 100 million in angel-round financing; Hengrui Medicine’s application for market approval of its oral small-molecule GLP-1 drug HRS-7535 was accepted; Gan & Lee Pharmaceuticals’ GZC8072 weekly oral formulation received approval to initiate clinical trials for type 2 diabetes; Fosun Pharma’s ruvomitinib gained approval for an additional indication in adult patients with plexiform neurofibroma; Betta Pharmaceuticals’ ensatinib received registration approval for adjuvant treatment of ALK-positive lung cancer post-surgery; and Akeso’s ivonescimab met a key secondary endpoint in the interim overall survival (OS) analysis of the HARMONi-2 study.
◍Market FlashPolicy · Industry Dynamics
9/3HUTCHMED Licenses HMPL-A830 to GSK: $110 Million Upfront Payment, with Total Potential Value of Up to $1.295 Billion
On September 3, HUTCHMED announced that its subsidiary, Hutchison MediPharma (Shanghai), has entered into an exclusive development and license agreement with a GlaxoSmithKline (GSK) affiliate, granting GSK the rights to develop and commercialize HMPL-A830, a KRAS-EGFR antibody-targeted toxin conjugate (ATTC), outside of Mainland China, Hong Kong, Macau, and Taiwan. The agreement includes an upfront payment of $110 million, up to $1.185 billion in development, regulatory, and commercial milestone payments, plus tiered royalties on net sales, for a potential total value of up to $1.295 billion. HUTCHMED will be responsible for global Phase I development, with trials expected to commence in the second half of 2026. GSK will handle subsequent overseas development and commercialization, with initial indications focusing on colorectal cancer, pancreatic cancer, and lung cancer.
Interpretation:The key to this deal is not “just another billion-dollar BD transaction,” but rather the evolution of domestically produced antibody-drug conjugates (ADCs) from traditional cytotoxic payloads toward a “dual strike on targets and pathways.” HMPL-A830 employs an EGFR antibody to deliver a KRAS inhibitor into tumors, simultaneously suppressing both EGFR and KRAS signaling in an effort to address the toxicity and resistance issues associated with systemic administration of pan-KRAS inhibitors. For HUTCHMED, retaining rights in mainland China, Hong Kong, Macao, and Taiwan means maintaining control over the domestic market. For GSK, acquiring global rights first and then leveraging its own development and commercialization capabilities to validate the new technology represents the purchase of a clinical option on a precision oncology platform.
9/2Expansion of the Scope of Consistency Evaluation: Ophthalmic Solutions to Launch First, with Patches and Sprays to Be Included Next Year
On September 2, the National Medical Products Administration (NMPA) issued an announcement deciding to gradually expand the quality and efficacy consistency evaluation of chemical generic drugs to dosage forms other than oral solid preparations and injections. The announcement specified that the consistency evaluation for ophthalmic solutions will commence upon the date of issuance, while the consistency evaluation for patches and sprays will begin on July 1, 2027. Marketing Authorization Holders (MAHs) shall select reference listed drugs based on the reference drug catalog published by the NMPA and conduct research and development for submission. For varieties requiring clinical trials, applicants must submit a clinical trial application to the Center for Drug Evaluation (CDE) and obtain approval before implementation.
Interpretation:The expansion of the consistency evaluation from oral solid dosage forms and injections to include eye drops, patches, and sprays signifies that quality competition among generic drugs has moved from “mainstream dosage forms” into more specialized therapeutic scenarios. The sterility, device compatibility, and local delivery stability required for eye drops, as well as the transdermal efficiency and adhesion properties of patches, cannot be assessed by simply replicating the evaluation logic used for oral medications. For pharmaceutical companies, this represents both a mandate for quality upgrading and a reshuffling of product portfolios: older products lacking reference listed drugs, clinical evaluations, or adequate manufacturing capabilities may face heightened compliance pressures and an increased risk of market elimination in the future.
9/1Medtronic Invests Approximately $700 Million in Cornerstone Robotics: Sentire Accelerates Overseas Commercialization
On September 1, Cornerstone Robotics announced a strategic partnership with Medtronic. Medtronic will make a strategic investment of approximately $700 million in Cornerstone Robotics and secure distribution rights for the Sentire laparoscopic surgical robot system in certain approved markets outside the United States. Sentire received approval from China’s National Medical Products Administration (NMPA) in 2024, and obtained EU CE marking and approval from Singapore’s Health Sciences Authority (HSA) in May 2026. The system supports minimally invasive procedures across general surgery, gynecology, thoracic surgery, and urology. Medtronic stated that Sentire will complement its Hugo robotic-assisted surgery system.
Interpretation:The challenges for surgical robot manufacturers expanding overseas have never been limited to obtaining regulatory approval; they lie more in the simultaneous rollout of hospital access, physician training, after-sales service, and consumables systems. Cornerstone Robotics brings its product and R&D capabilities to the partnership, while Medtronic provides global channels and clinical resources, forming a combination of “technical assets + commercial networks.” The approximately $700 million strategic investment also indicates that the overseas expansion of Chinese-made medical devices is beginning to feature deep binding relationships different from one-time distribution licenses: international giants are not just selling products, but are locking in next-generation platforms in advance.
◍Capital InformationMarket Trends · Financing · IPO
9/3NeuOrchard Pharma Completes Over $80 Million in Series B Financing: Betting on Global Clinical Development in CNS
On September 3, NeuShen Therapeutics announced the completion of an oversubscribed Series B financing round exceeding USD 80 million. Participants included B Capital, Legend Capital, Matrix Partners China, Zhenmai Investment, and Shanghai State-owned Capital Venture Guidance Fund, among others, with existing shareholder Lilly Asia Ventures continuing to increase its investment. The proceeds from this round will be primarily used to expand the company’s innovative pipeline in the central nervous system (CNS) field and accelerate the global clinical development of its core projects. Currently, all three of the company’s core assets are in clinical development: NS-079 has initiated its first-in-human trial in Australia; NS-136 is undergoing Phase 2 studies for agitation symptoms associated with schizophrenia and Alzheimer’s disease; and NS-041 is in the Phase 2 multicenter enrollment stage for focal epilepsy.
Interpretation:Innovative CNS drugs have long been the most challenging sector for capital investment, yet they offer potentially substantial returns upon success: disease mechanisms are complex, clinical endpoints are highly subjective, and trial failures often occur in late stages. The highlight of Neuora’s latest funding round lies in the fact that the capital is not dedicated to supporting a single star molecule, but rather covers multiple unmet needs across depression, schizophrenia, Alzheimer’s disease, and epilepsy. The continued investment by Lilly Asia Ventures adds an layer of industry endorsement to the company’s global clinical development strategy; however, whether it can ultimately navigate the uncertainties inherent in CNS R&D will still depend on randomized controlled trial data.
9/3AIPher Completes Hundred-Million-Yuan Angel Round: AI Drug Discovery Evolves from Tools to R&D Systems
On September 3, AI-native drug discovery company AIPher announced the completion of a RMB 100 million angel financing round, led by Xianghe Capital, with participation from StarLink Capital and industrial funds. The funding will be used for the research, development, and iteration of its DrugCLIP foundational model for drugs and the PharmAgents AI-driven drug discovery engine; to establish a multimodal closed-loop system integrating computational (dry) and experimental (wet) drug discovery processes; and to advance its proprietary and collaborative innovative drug pipelines. The company’s fastest-moving in-house pipeline has entered the pre-PCC stage, and it is currently engaged in joint development collaborations with more than five pharmaceutical companies and biotech firms in areas including metabolism, central nervous system (CNS) disorders, autoimmune diseases, and drug delivery.
Interpretation:AI drug discovery is undergoing a significant bifurcation: the first stage involves using models to perform single-point tasks such as virtual screening and structure prediction, while the next stage entails engaging AI in R&D decision-making regarding “what experiments to conduct next.” AIPher has chosen to start with organizational structure and processes, integrating foundation models, agents, medicinal chemistry, and wet-lab experiments into a unified feedback loop, aiming to have experimental results inversely train the system. The true barrier in this direction lies not in model demonstrations, but in the ability to consistently produce reproducible candidate molecules and shorten the cycle from hypothesis to preclinical validation.
◍Pharmaceutical UpdatesDomestic Approval · Clinical Progress
9/3Everest Medicines’ Xingbituo Approved: Out-of-Hospital Rescue Medication Now Available for Acute Episodes of Supraventricular Tachycardia in Adults
On September 3, Everest Medicines announced that the National Medical Products Administration (NMPA) has approved Xingbituo (etripamil nasal spray) for the treatment of acute episodes of paroxysmal supraventricular tachycardia (PSVT) in adults, facilitating conversion to sinus rhythm. The company stated that Xingbituo is the first innovative therapy in China for acute PSVT episodes that can be self-administered by patients outside of healthcare settings. It takes effect as early as 5 minutes after administration, with nearly two-thirds of patients restoring sinus rhythm within 30 minutes and a median time to conversion of 17.2 minutes. This approval is based on the global Phase III RAPID study and the Chinese Phase III JX02002 study. In the RAPID study, the conversion rate within 30 minutes was 64% in the Xingbituo group versus 31% in the placebo group.
Interpretation:Long-term management of paroxysmal supraventricular tachycardia (PSVT) has heavily relied on emergency care, with patients often left to wait for spontaneous resolution or seek hospital treatment during sudden episodes of palpitations. The nasal spray shifts the treatment window from in-hospital settings to the site of onset, transforming not only the route of administration but also the management pathway for acute arrhythmias: patients can self-administer the medication as needed, while the healthcare system has the opportunity to reduce unnecessary emergency department visits. For Everest Medicines, Xingbituo represents its first approved innovative drug in the cardiovascular field. The true test of commercialization now lies in whether physician education, patient ability to identify episodes, prescription accessibility, and payment coverage can collectively establish an out-of-hospital self-rescue scenario.
9/3Hengrui’s Oral GLP-1 New Drug HRS-7535: Marketing Application Accepted; Submission Supported by Two Phase III Trials
On September 3, Shandong Shengdi Pharmaceutical, a subsidiary of Hengrui Medicine, received an acceptance notice from the National Medical Products Administration (NMPA) for the marketing authorization application of HRS-7535 tablets. The drug is intended for glycemic control in adult patients with type 2 diabetes. The acceptance numbers are CXHS2600122 and CXHS2600123. HRS-7535 is an oral small-molecule GLP-1 receptor agonist. This submission is based on two pivotal Phase III studies, OUTSTAND-1 and OUTSTAND-2. In these studies, the reductions in glycated hemoglobin (HbA1c) across various dose groups ranged from 1.40% to 1.68% and from 1.50% to 1.68%, respectively. Additionally, multifaceted benefits including weight loss, reduced urinary protein, lowered blood pressure, and improved lipid profiles were observed.
Interpretation:The competitive focus of oral GL-1 receptor agonists is not merely about replacing injections with tablets, but rather achieving a balance among absorption efficiency, dosing frequency, gastrointestinal tolerability, and production costs. If ultimately approved, HRS-7535 will join the commercial competition for domestically produced oral small-molecule GL-1 receptor agonists. Two Phase III studies have demonstrated benefits in glycemic control and metabolic parameters; however, regulatory review for market approval will continue to verify long-term safety, patient adherence, and real-world convenience of use. For Jiangsu Hengrui Medicine, the oral formulation also serves as a key product pillar in its expansion from innovative oncology drugs to chronic metabolic diseases.
9/3Gan & Lee’s GZC8072 Approved for Clinical Trials: The Race for the World’s First Oral Weekly Formulation Continues
On September 3, Gan & Lee Pharmaceuticals announced that its wholly-owned subsidiary, Gan & Lee Pharmaceuticals (Shandong), had received a Notice of Approval for Clinical Drug Trials issued by the National Medical Products Administration (NMPA), approving the conduct of clinical trials for the investigational drug GZC8072 tablets for the indication of type 2 diabetes. GZC8072 is a next-generation biased ultra-long-acting peptide oral weekly formulation independently developed by the company leveraging its NovaPeptide and SupOraTide platforms, aiming to support once-weekly oral dosing by extending half-life and improving oral bioavailability. As of June 30, 2026, the cumulative R&D investment in this project amounted to RMB 66.3326 million.
Interpretation:If oral GL-1 therapies address the need to “avoid injections,” then once-weekly oral formulations go a step further by eliminating the need for “daily dosing.” However, the core challenge with oral peptide drugs has always been absorption rate and systemic exposure. The less frequent the dosing regimen, the higher the requirements for molecular potency, formulation technology, and clinical stability. GZC8072 has just been approved for clinical trials, so it is still some way from demonstrating efficacy and safety. Its industrial significance lies in the fact that competition in China’s GLP-1 market has evolved beyond targets and weight-loss magnitude to a contest over dosing frequency and long-term patient adherence.
9/3Fosun Pharma’s Luvozemtinib Receives Approval for New Indication in Adults with Plexiform Neurofibroma
On September 3, Fosun Pharma announced that the National Medical Products Administration (NMPA) has approved a new indication for luvotemitinib tablets (brand name: Fumaining; project code: FCN-159), developed by its controlling subsidiary, Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd. The approved indication is for adult patients with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). Luvotemitinib is a selective MEK1/2 inhibitor that had previously been approved in China for indications including pediatric and adolescent patients. The approval of this adult indication further expands the eligible patient population.
Interpretation:The commercialization challenges of orphan drugs often lie not in the availability of therapies, but in bridging limited patient populations, long-term medication needs, and management across diverse age groups. The expansion of ruvomitinib’s indication from pediatric and adolescent patients to adults signifies that the therapeutic value of this mechanism is beginning to cover a more complete disease lifecycle. For pharmaceutical companies, expanding age-specific indications improves the utilization rate of existing R&D assets; for patients, who still lack treatment options for inoperable plexiform neurofibromas, the clinical significance of new indications hinges on accessibility, affordability, and long-term safety.
9/3BET-A01 Approved for Adjuvant Treatment of Lung Cancer: 2-Year DFS Rate Reaches 86.4%
On September 3, BETA Pharma announced that it had received the drug registration certificate for ensartinib hydrochloride capsules (brand name: Beimeina) issued by the National Medical Products Administration (NMPA). The approval is for postoperative adjuvant therapy in patients with ALK-positive stage IB to IIIB non-small cell lung cancer (NSCLC), who must have previously undergone surgical resection, with the decision on whether to receive adjuvant chemotherapy made by their physician. This marks the third approved indication for ensartinib. The approval was based on the Phase III ELEVATE postoperative adjuvant study, which showed a 24-month disease-free survival rate of 86.4% and a hazard ratio for disease recurrence or death of 0.20 in patients with stage II to IIIB disease; overall survival data are not yet mature.
Interpretation:The competitive landscape for treating ALK-positive lung cancer is shifting from late-stage disease control to postoperative recurrence prevention. The recent approval of ensartinib holds core value beyond merely adding an indication; it integrates targeted therapy into the long-term management pathway for early-stage lung cancer: surgery first, followed by risk-stratified adjuvant therapy, with the goal of minimizing recurrence as much as possible. While the 2-year DFS rate and HR data are compelling, the long-term benefits of adjuvant therapy must ultimately be validated by mature overall survival data, treatment duration, and adverse event management. For Betta Pharmaceuticals, this represents a critical milestone in extending the lifecycle of a mature product and expanding its clinical application scenarios.
9/3Akeso’s Ivonescimab HARMONi-2 OS Interim Analysis Positive: Another Head-to-Head Victory Over Keytruda
On September 3, Akeso announced that the prespecified interim analysis of overall survival (OS), a key secondary endpoint, in its Phase III HARMONi-2 study had met the endpoint upon assessment by the Independent Data Monitoring Committee. The study evaluated ivonescimab (brand name: Yidafang; a PD-1/VEGF bispecific antibody) monotherapy versus pembrolizumab monotherapy as first-line treatment for locally advanced or metastatic non-small cell lung cancer (NSCLC) with positive PD-L1 expression. The results demonstrated statistical significance and clinical benefit. The study enrolled a total of 398 subjects. The primary endpoint, progression-free survival (PFS), had previously been met, with median PFS of 11.14 months in the ivonescimab group and 5.82 months in the control group, yielding a hazard ratio (HR) for PFS of 0.51.
Interpretation:Whether a domestically developed innovative drug can become a “cornerstone therapy” depends not on the aesthetic appeal of a single endpoint, but on its ability to demonstrate benefits in both progression-free survival (PFS) and overall survival (OS) simultaneously in head-to-head randomized Phase III trials. The positive interim OS analysis for Ivonescimab has elevated the value proposition of PD-1/VEGF bispecific antibodies from mechanistic narratives to evidence of long-term survival benefit; however, specific hazard ratios (HR), subgroup analyses, and safety data still await full disclosure at international conferences or in peer-reviewed publications. The next phase of competition will shift from “whether it can outperform Keytruda” to the expansion of approved indications, integration into clinical pathways, and payment accessibility.
◍Global Pharma NewsGlobal Perspective · Cross-Border Dynamics
9/2Alteogen Strikes Deal with Novartis Worth Up to $3.223 Billion: Subcutaneous Formulation Platform Secures Another Major Order
On September 2, Alteogen announced that it had entered into an option and license agreement with Novartis. Under the agreement, Novartis will obtain multiple options to develop and commercialize several subcutaneous formulations using Alteogen’s ALT-B4 (berahyaluronidase alfa). If all options are exercised and all development and commercialization milestones are achieved, Alteogen will be eligible to receive up to $3.223 billion, including option exercise fees and development and commercialization milestone payments, plus royalties on net product sales. ALT-B4, based on the Hybrozyme platform, temporarily degrades hyaluronic acid in subcutaneous tissue, enabling biologics that originally require intravenous infusion to be administered via a faster and more convenient subcutaneous route.
Interpretation:The Value of Subcutaneous Formulation Platforms Is Evolving from “Enhancing Patient Experience” to Becoming Infrastructure for Big Pharma to Restructure Product Life Cycles. Switching from intravenous infusion to subcutaneous injection can reduce occupancy in infusion centers, shorten administration time, and potentially help mature biologics extend their patent and commercial lifecycles. Alteogen has secured multiple ALT-B4 collaboration deals this year, indicating that the business development valuation of platform technologies is no longer based solely on individual drugs, but rather on their ability to be repeatedly leveraged across multiple therapeutic areas and administration scenarios. The $3.223 billion figure represents the potential total value including options, milestones, and sales royalties, and should not be equated with immediate revenue.
9/2uniQure Submits Marketing Application for AMT-130: Huntington’s Disease Gene Therapy Makes First Push Toward Regulatory Approval
On September 2, uniQure announced that it had submitted a Biologics License Application (BLA) to the U.S. FDA for its investigational gene therapy ifezuntirgene inilparvovec (AMT-130), seeking accelerated approval for the treatment of Huntington’s disease. The company simultaneously submitted a Marketing Authorization Application (MAA) to the UK Medicines and Healthcare products Regulatory Agency (MHRA). The submission was primarily based on three-year data from the Phase 1/2 study of AMT-130, compared with propensity score-matched external controls derived from the Enroll-HD natural history database. The company has requested Priority Review from the FDA; if accepted and granted, the review timeline is expected to be shortened to six months. uniQure plans to release four-year data before the end of the third quarter of 2026.
Interpretation:AMT-130 targets a neurodegenerative disease for which there are currently no approved therapies to slow disease progression. The single-administration gene-silencing approach offers the potential for a “one-time treatment, long-term observation” paradigm. However, regulatory evaluation of such therapies faces challenges: small patient populations, slow disease progression, limitations associated with both randomized controlled trials and natural history-based external controls, and the requirement for stereotactic neurosurgical delivery. Submission of a Biologics License Application (BLA) represents a significant milestone but does not constitute FDA acceptance or approval. Subsequent review will assess whether data from external controls, durability of efficacy, and risks associated with surgical administration collectively provide sufficient basis for approval.
9/2United Therapeutics’ Inhaled Tyvaso Accepted by FDA: A Potential New Mechanism for Idiopathic Pulmonary Fibrosis
On September 2, United Therapeutics announced that the U.S. FDA has accepted the supplemental New Drug Application (sNDA) for inhaled Tyvaso (treprostinil inhalation solution) for the treatment of idiopathic pulmonary fibrosis (IPF), with a review completion expected by the end of April 2027. This submission is based on two Phase III studies, TETON-1 and TETON-2. A pooled analysis demonstrated that at 52 weeks of treatment, the Tyvaso group showed a statistically significant improvement of 111.8 mL in absolute forced vital capacity (FVC) compared to placebo. Additionally, positive results were observed in clinical deterioration, acute exacerbations, and certain pulmonary function and quality-of-life metrics. The drug has not yet been approved by the FDA for IPF and remains an investigational therapy for this indication.
Interpretation:The long-term treatment of idiopathic pulmonary fibrosis (IPF) has consistently faced two practical challenges: the irreversible progression of the disease, and the tolerability and adherence burdens often associated with existing antifibrotic agents. Tyvaso’s potential differentiation lies in its direct pulmonary delivery, simultaneously targeting fibrotic, vascular, and inflammatory pathways. If approved, it could become the first inhaled antifibrotic therapy. However, improvement in forced vital capacity (FVC) does not automatically translate into improved long-term survival for patients. Regulatory review will continue to assess whether endpoints such as acute exacerbations, hospitalizations, quality of life, and safety collectively demonstrate comprehensive clinical benefit.
9/2TScan Cuts Workforce by ~75% to Pivot to In Vivo TCR-T Therapy: Funding Constraints Force Cell Therapy Sector Shift
On September 2, TScan Therapeutics announced a strategic restructuring to concentrate resources on its in vivo engineered TCR-T programs for solid tumors, advancing two candidate products targeting PRAME and MAGE-A4 into IND-enabling studies. The company plans to submit its first Investigational New Drug (IND) application in 2027 and initiate Phase I clinical trials in the fourth quarter. Due to insufficient funding, TScan has suspended further enrollment in the Phase III ALLOHA-2 study of TSC-101 for hematologic malignancies, while continuing to follow up with enrolled patients and seeking partnership opportunities. The restructuring will eliminate the internal manufacturing organization and scale down R&D operations, resulting in an estimated 75% reduction in workforce. The company expects its cash reserves to sustain operations through the fourth quarter of 2027.
Interpretation:This is not merely a matter of workforce optimization, but rather a public dissection of the commercialization challenges facing cell therapy. Traditional autologous cell therapies require collection, ex vivo modification, expansion, and reinfusion, resulting in high manufacturing costs, long wait times, and limited scalability. In vivo engineered TCR-T therapies attempt to shift the “manufacturing” process back into the patient’s body, but delivery efficiency, cell specificity, and safety control remain insufficiently validated. TScan’s suspension of its Phase III program and its strategic pivot to concentrate resources on in vivo therapies indicate that capital markets are no longer willing to fund all technological approaches simultaneously. Cell therapy companies must now make more ruthless trade-offs between clinical value and manufacturing economics.