Medtronic Invests ~$700M in Cornerstone Robotics; Akeso's Ivonescimab HARMONi-2 OS Interim Analysis Positive

A digest of major deals, approvals, and financing rounds shaping China's pharmaceutical and medical-device landscape in early September 2026.

When Cornerstone Robotics needed a global partner to take its Sentire laparoscopic surgical robot beyond China's borders, the company didn't reach for a distributor. It reached for Medtronic.

On September 1, the Chinese surgical-robotics startup announced that Medtronic will make a strategic investment of approximately $700 million (USD) and secure distribution rights for Sentire in certain approved markets outside the United States. Sentire, which won approval from China's National Medical Products Administration (NMPA) in 2024, earned EU CE marking and Singapore Health Sciences Authority clearance in May 2026. The system covers general surgery, gynecology, thoracic surgery, and urology.

Medtronic said Sentire will complement its existing Hugo robotic-assisted surgery platform rather than compete with it. For Cornerstone Robotics — known in China as Kangnuositeng — the deal represents a new model for Chinese medical-device companies going global: not a one-off distribution license, but a deep equity tie-up with an international incumbent that brings hospital access, surgeon training, after-sales infrastructure, and consumable supply chains.

A Positive Signal for Akeso's Bispecific Antibody

In oncology, Akeso reported that an interim analysis of overall survival (OS) in its Phase III HARMONi-2 study met the key secondary endpoint with statistical significance.

The trial pits Akeso's ivonescimab — a PD-1/VEGF bispecific antibody marketed as Yidafang in China — against pembrolizumab monotherapy as first-line treatment for patients with PD-L1-positive locally advanced or metastatic non-small-cell lung cancer (NSCLC). An independent data monitoring committee assessed the OS interim results.

The study enrolled 398 patients. Its primary endpoint, progression-free survival (PFS), was previously met: median PFS was 11.14 months for the ivonescimab arm versus 5.82 months for the control arm, yielding a hazard ratio of 0.51. Specific OS hazard ratios and subgroup data have not yet been disclosed; full results are expected at a major medical conference or via peer-reviewed publication.

For Akeso, the OS signal strengthens the case for ivonescimab as a potential backbone therapy. The next competitive question shifts from "can it beat Keytruda on PFS?" to how quickly the drug can expand approved indications, embed itself in clinical pathways, and secure reimbursement access.

HUTCHMED Licenses KRAS-EGFR Conjugate to GSK for Up to $1.295 Billion

In what is being read as a bet on next-generation antibody-drug conjugate (ADC) technology, HUTCHMED announced on September 3 that it has granted GSK exclusive rights to develop and commercialize HMPL-A830 — a KRAS-EGFR antibody-targeted conjugate (ATTC) — outside mainland China, Hong Kong, Macau, and Taiwan.

The deal carries a $110 million (USD) upfront payment, up to $1.185 billion (USD) in development, regulatory, and commercialization milestones, plus tiered royalties on net sales, for a potential total value of $1.295 billion (USD).

HMPL-A830 uses an EGFR antibody to deliver a KRAS inhibitor directly into tumor cells, simultaneously suppressing both EGFR and KRAS signaling pathways. The approach aims to address the toxicity and resistance problems associated with systemic pan-KRAS inhibitors. First indications are expected to focus on colorectal cancer, pancreatic cancer, and lung cancer.

HUTCHMED will lead global Phase I development, with the trial expected to begin in the second half of 2026. GSK will take over overseas development and commercialization thereafter.

Regulatory Expansion: Consistency Evaluations Move Beyond Pills and Injections

China's NMPA announced on September 2 that it will expand its generic-drug consistency-evaluation program — long focused on oral solid dosage forms and injectables — to eye drops, patches, and sprays. Eye-drop evaluations begin immediately; patches and sprays will follow starting July 1, 2027.

The expansion signals that quality competition among generic manufacturers is moving into more specialized delivery formats, each with distinct technical hurdles: sterility and device compatibility for eye drops, transdermal efficiency and adhesion for patches, and local-delivery stability for sprays.

Everest Medicines' Nasal Spray Wins Approval for Out-of-Hospital PSVT Treatment

Everest Medicines announced on September 3 that the NMPA has approved eptaparmir nasal spray — marketed as Xingbituo in China — for the acute treatment of paroxysmal supraventricular tachycardia (PSVT) in adults. The company says it is the first innovative therapy that patients can self-administer outside a hospital setting during a PSVT episode.

The drug can take effect as early as five minutes after administration. Nearly two-thirds of patients achieve conversion to normal sinus rhythm within 30 minutes, with a median conversion time of 17.2 minutes. Approval was based on the global Phase III RAPID study and the Chinese Phase III JX02002 study. In RAPID, the 30-minute conversion rate was 64% for eptaparmir versus 31% for placebo.

Hengrui's Oral GLP-1 NDA Accepted; Gan & Lee Advances Weekly Oral Peptide

Hengrui Medicine's subsidiary Shandong Shengdi Pharma received NMPA acceptance for the new-drug application of HRS-7535, an oral small-molecule GLP-1 receptor agonist, for glycemic control in adults with type 2 diabetes. Acceptance numbers are CXHS2600122 and CXHS2600123.

The filing is supported by two pivotal Phase III studies, OUTSTAND-1 and OUTSTAND-2. In these trials, HbA1c reductions across dose groups ranged from 1.40% to 1.68% and from 1.50% to 1.68%, respectively, with additional benefits observed in weight loss, urinary protein reduction, blood-pressure control, and lipid improvement.

Separately, Gan & Lee Pharmaceutical announced on September 3 that its subsidiary in Shandong has received NMPA approval to begin clinical trials for GZC8072, a next-generation biased ultra-long-acting oral peptide weekly formulation developed on the company's NovaPeptide and SupOraTide platforms. As of June 30, 2026, the company has invested a cumulative 66.33 million RMB (approximately $9.1 million USD) in the program.

Expanding Indications: Fosun, BeiDa Add Adult and Adjuvant Uses

Fosun Pharma's lavolutinib (brand name Fumaining, project code FCN-159), a selective MEK1/2 inhibitor, won NMPA approval on September 3 for a new indication: adult patients with neurofibromatosis type 1 (NF1)–associated symptomatic, inoperable plexiform neurofibroma. The drug was already approved in China for pediatric and adolescent patients; the adult label broadens its addressable population.

BeiDa药业's ensartinib (brand name Beimeina) received a new registration certificate for ALK-positive stage IB to IIIB non-small-cell lung cancer as post-surgical adjuvant therapy — the drug's third approved indication. Approval was based on the Phase III ELEVATE adjuvant study, which showed a 24-month disease-free survival rate of 86.4% in stage II to IIIB patients, with a hazard ratio for recurrence or death of 0.20. Overall survival data are not yet mature.

Capital Flows: NeuShen Raises Over $80 Million; AIPher Closes Angel Round

NeuShen Therapeutics announced on September 3 the closing of an oversubscribed Series B round of over $80 million (USD). Investors include B Capital, Legend Capital, Matrix Partners China, Zhenmai Investment, and Shanghai Guotou Xiandao, with continued participation from Lilly Asia Ventures. Funds will support global clinical development across three pipeline programs: NS-079 (first-in-human trial launched in Australia), NS-136 (Phase II for schizophrenia and Alzheimer's agitation), and NS-041 (Phase II for focal epilepsy).

AI-native drug-discovery company AIPher also announced on September 3 the closing of a 100-million-RMB (approximately $13.7 million USD) angel round led by Xianghe Capital, with follow-on investment from Xinglian Capital and industry funds. The company is developing DrugCLIP, a foundational drug-discovery model, and PharmAgents, an AI agent engine for pharmaceutical R&D. AIPher's most advanced proprietary pipeline candidate has reached the Pre-PCC stage, and the company is co-developing programs with more than five pharmaceutical and biotech partners across metabolic, CNS, autoimmune, and drug-delivery indications.

Global Developments

South Korea's Alteogen announced on September 2 a option and licensing deal with Novartis for its ALT-B4 (berahyaluronidase alfa) subcutaneous-formulation platform. If all options are exercised and all milestones are met, Alteogen could receive up to $3.223 billion (USD), including option-exercise fees, development and commercialization milestones, plus royalties on net sales. ALT-B4, based on the Hybrozyme platform, temporarily degrades hyaluronic acid in subcutaneous tissue to convert intravenous biologics into faster subcutaneous injections.

uniQure submitted a biologics license application (BLA) to the U.S. FDA on September 2 for ifezuntirgene inilparvovec (AMT-130), seeking accelerated approval for Huntington's disease. The company also filed a marketing authorization application with the UK's MHRA. The submission is based on three-year data from a Phase I/II study compared against propensity-score-matched external controls from the Enroll-HD natural-history database. If granted priority review, the FDA review period could be shortened to six months.

United Therapeutics announced on September 2 that the FDA has accepted its supplemental new-drug application for inhaled Tyvaso (treprostinil inhalation solution) for idiopathic pulmonary fibrosis (IPF), with a PDUFA target date before the end of April 2027. In a pooled analysis of the Phase III TETON-1 and TETON-2 studies, Tyvaso improved absolute forced vital capacity by 111.8 mL versus placebo at 52 weeks, reaching statistical significance.

TScan Therapeutics announced a strategic restructuring on September 2, pivoting to in-vivo engineered TCR-T therapies for solid tumors and laying off approximately 75% of its workforce. The company suspended enrollment in the Phase III ALLOHA-2 study of its hematology candidate TSC-101 due to funding constraints. TScan expects its cash to sustain operations through the fourth quarter of 2027, with a first IND filing planned for later that year.