Biopharmaceuticals

FDA Grants Breakthrough Therapy Status to Armata's AP-SA02 Phage Drug

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FDA Grants Breakthrough Therapy Status to Armata's AP-SA02 Phage Drug

Los Angeles – September 17, 2026 -- The U.S. Food and Drug Administration has granted Breakthrough Therapy designation to Armata Pharmaceuticals' AP-SA02, an intravenous multi-phage candidate for complicated Staphylococcus aureus bacteremia, stacking the designation atop existing Fast Track and Qualified Infectious Disease Product status.

NUS Magnetic Pulse Therapy Eradicates Tumors in 75% of Preclinical Trials

Singapore – September 16, 2026 -- Researchers at the National University of Singapore (NUS) have eradicated tumours in 75 per cent of tested preclinical models using pulsed electromagnetic fields (PEMFs) alone, without chemotherapy, after just four 30-minute sessions. The study, led by Associate Professor Alfredo Franco-Obregón of the NUS Yong Loo Lin School of Medicine, was published in the journal Smart Medicine on June 4, 2026.

PEMF device already cleared Phase 1 human safety trials

The same PEMF device used in the study has completed Phase 1 clinical trials, confirming its safety in humans. The NUS team is now seeking partners to fund and conduct Phase 2 efficacy trials to evaluate treatment performance in patients.

Kelun-Biotech's HER2 ADC Beats T-DM1 in Phase III, Wins China Approval

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Kelun-Biotech's HER2 ADC Beats T-DM1 in Phase III, Wins China Approval

Chengdu – September 16, 2026 -- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (6990.HK) said phase III results for its HER2-targeted antibody-drug conjugate trastuzumab botidotin have been published in the Journal of Clinical Oncology, a journal with an impact factor of 44.7, after the drug outperformed Roche's trastuzumab emtansine (T-DM1) in a head-to-head trial and secured approval from China's National Medical Products Administration.

Abe Yoando Pharma Chief First Japanese Speaker at Swiss Longevity Summit

Gstaad – September 16, 2026 -- Tomonari Abe, President of 295-year-old Abe Yoando Pharma Co., Ltd., has become the first Japanese speaker in the history of the Longevity Investors Conference, running September 14-17, 2026 in Gstaad, Switzerland.

Global longevity market poised to hit $8 trillion by 2030

The healthy longevity sector is projected to reach approximately $8 trillion by 2030, according to a UBS Chief Investment Office research report cited by the company. International investors are increasingly focused on Japan's aging population as a testing ground for longevity science and market validation ahead of other nations.

Antengene Data Show CD73 Inhibitor Boosts Selinexor Efficacy in Myeloma

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Antengene Data Show CD73 Inhibitor Boosts Selinexor Efficacy in Myeloma

Shanghai and Hong Kong – September 16, 2026 -- Antengene Corporation Limited (SEHK: 6996.HK) has published preclinical data showing that combining its CD73 inhibitor ATG-037 with selinexor suppressed tumor growth by 62% in a multiple myeloma mouse model, versus 31% for ATG-037 alone and 43% for selinexor alone. The peer-reviewed paper, developed with the Department of Hematology at Peking University Third Hospital, appears in Cancer Gene Therapy, an SCI journal under Springer Nature (DOI: 10.1038/s41417-026-01078-9).

Accro's AC-101 Enters NMPA Rare Disease Pilot for Blau Syndrome

Suzhou – – September 16, 2026 -- Accro Bioscience said AC-101 tablets have been included in the National Medical Products Administration's Center for Drug Evaluation (CDE) "Caring Plan-Extension" pilot program, targeting Blau syndrome as the proposed indication, with the public notice period closing September 11, 2026.

NMPA pilot program aims to accelerate rare disease drug development in China

The Caring Plan-Extension pilot, run by China's CDE, is designed to encourage innovative drug development for rare diseases. Accro Bioscience confirmed the inclusion took effect September 14, 2026, China Standard Time (UTC+8).

FDA granted AC-101 Rare Pediatric Disease designation three months earlier

The U.S. Food and Drug Administration awarded AC-101 Rare Pediatric Disease (RPD) designation for Blau syndrome in June 2026, ahead of the Chinese regulatory step.

Whitehawk Data Show PTK7 Target Stable After Lung Cancer Treatment

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Whitehawk Data Show PTK7 Target Stable After Lung Cancer Treatment

Morristown, N.J. – September 16, 2026 -- Whitehawk Therapeutics (Nasdaq: WHWK) presented real-world data at the IASLC 2026 World Conference on Lung Cancer in Seoul showing that PTK7 expression remains stable in pretreated, EGFR wild-type non-small cell lung cancer (NSCLC), reinforcing the target biology behind its Phase 1 antibody-drug conjugate (ADC) HWK-007.

RYBREVANT Combo Extends Survival to 34.3 Months in Lung Cancer Trial

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RYBREVANT Combo Extends Survival to 34.3 Months in Lung Cancer Trial

Seoul – September 16, 2026 -- Johnson & Johnson reported that its RYBREVANT (amivantamab-vmjw) plus chemotherapy combination extended median overall survival to 34.3 months in patients with EGFR exon 20 insertion-mutated advanced non-small cell lung cancer, compared with 27.9 months for chemotherapy alone, according to final data from the Phase 3 PAPILLON study.

Combination therapy nearly doubles historical survival benchmarks

The result marks the longest reported median overall survival for this patient population, which has historically faced a five-year survival rate of just 8 percent and a median overall survival ranging from 16 to 24 months. EGFR exon 20 insertion mutations account for approximately 12 percent of all EGFR mutations and have proven difficult to treat with existing targeted therapies.

Ris-Rez Cuts Death Risk 54% in Phase III Relapsed Lung Cancer Trial

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Ris-Rez Cuts Death Risk 54% in Phase III Relapsed Lung Cancer Trial

Seoul – September 16, 2026 -- Risvutatug rezetecan (Ris-Rez), a B7-H3-directed antibody-drug conjugate, reduced the risk of death by 54% compared with topotecan in patients with relapsed small-cell lung cancer, according to Phase III ARTEMIS-008 trial results presented at the IASLC 2026 World Conference on Lung Cancer.

Ris-Rez extends median overall survival to 18.5 months versus 10.3 months for topotecan

The multicenter, open-label trial (NCT06498479) randomized 461 patients in China 1:1 to receive Ris-Rez at 8.0 mg/kg every three weeks or topotecan at 1.2 mg/m2 on days 1 through 5 every three weeks. More than 80% of enrolled patients had previously received PD-(L)1 inhibitors. At the June 6, 2026 data cutoff, after a median follow-up of 12.2 months, the hazard ratio for death favored Ris-Rez at 0.46 (95% CI, 0.35–0.62; P0.0001), with the survival benefit consistent across relevant subgroups.

Akeso's Ivonescimab Cuts Death Risk 27% vs Keytruda in NSCLC Trial

Hong Kong – September 16, 2026 -- Akeso, Inc. (9926.HK) reported that its bispecific antibody ivonescimab reduced the risk of death by 27% compared with Merck's pembrolizumab in a Phase III trial of PD-L1-positive non-small cell lung cancer (NSCLC), with results presented as a Late-Breaking Abstract at the 2026 World Conference on Lung Cancer (WCLC).

Ivonescimab extends median survival to 30.8 months in head-to-head trial

In the intention-to-treat population of the HARMONi-2 study (AK112-303), patients treated with ivonescimab monotherapy achieved a median overall survival (OS) of 30.8 months versus 22.6 months for pembrolizumab (HR=0.73; 95% CI: 0.57–0.95; P=0.009). The data cutoff was August 20, 2026, with a median follow-up of 36 months and 234 OS events recorded. Professor Caicun Zhou, principal investigator and IASLC President, is scheduled to deliver the full oral presentation on September 15.