Pharmaceuticals & Biopharmaceuticals

Durham – November 06, 2026 -- Brii Biosciences (2137.HK) reported that 41.9% of participants (62/148) in its Phase 2b ENRICH study achieved hepatitis B surface antigen (HBsAg) loss at end of treatment (EOT), with 32.4% (48/148) sustaining it 24 weeks later. The data were presented in three late-breaking sessions at the AASLD Liver Meeting in Denver, running November 5 to 9, 2026.

ENRICH reproduces the BRII-179 priming effect seen in ENSURE Cohort 4

ENRICH prospectively tested a strategy first identified in Cohort 4 of the ENSURE study, where BRII-179-experienced participants, particularly those developing anti-HBs responses, showed higher functional cure rates. Participants received BRII-179 every 3 or 2 weeks for 12 weeks before elebsiran and pegylated interferon alpha (PEG-IFNα). Results across both dose regimens matched the ENSURE observations.

Shanghai – November 06, 2026 -- Antengene Corporation Limited (SEHK: 6996.HK) has dosed the first patient in China in the Phase I ATTRACT study of ATG-201, its CD19 x CD3 bispecific T-cell engager (TCE) for adult patients with B cell-mediated autoimmune diseases. UCB holds worldwide exclusive rights to develop, manufacture and commercialize the asset.

UCB holds global rights while Antengene runs Phase I in China and Australia

Under the agreement, UCB also gains access to the manufacturing technology associated with ATG-201. Antengene remains responsible for conducting the Phase I trials in China and Australia.

The Australian arm has cleared its regulatory steps. ATG-201 has obtained approval from the Human Research Ethics Committee (HREC) and completed the Clinical Trial Notification (CTN) process with the Therapeutic Goods Administration (TGA).

THOUSAND OAKS – November 06, 2026 -- Amgen reported that Repatha (evolocumab) lowered the risk of fatal or nonfatal heart attack by 20% compared with ezetimibe in adults with atherosclerotic cardiovascular disease (ASCVD) and prior statin use. The real-world study followed 544,103 patients for up to four years and was published in The American Journal of Preventive Cardiology.

Four-year heart attack risk falls to 5.88% with Repatha versus 7.76% with ezetimibe

Among 225,048 patients with a baseline LDL-C measurement, the four-year cumulative risk of heart attack was 5.88% on Repatha and 7.76% on ezetimibe. Among patients without a baseline LDL-C measurement, the corresponding risks were 5.65% and 7.06%.

The primary outcome was fatal or nonfatal myocardial infarction. The hazard ratio was 0.80 (95% CI, 0.70-0.91).

Hong Kong – November 06, 2026 -- Akeso's PD-1/VEGF bispecific antibody ivonescimab combined with chemotherapy produced a 70.1% major pathological response (MPR) rate and a 50.7% pathological complete response (pCR) rate in resectable non-small cell lung cancer (NSCLC), according to Phase II results published in Nature Medicine.

Chemotherapy combination delivers 70.1% MPR and 100% R0 resection

The trial tested perioperative ivonescimab as monotherapy or with chemotherapy. Patients received neoadjuvant treatment, then surgery, then adjuvant ivonescimab. Among patients who underwent surgery in the combination cohort, 68.7% had residual viable tumor of 5% or less.

NEW BRUNSWICK, N.J. – November 06, 2026 -- The U.S. Food and Drug Administration has granted accelerated approval to Johnson & Johnson's RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) for recurrent or metastatic head and neck squamous cell carcinoma (HNSCC), backed by a confirmed 42 percent overall response rate in a 102-patient cohort.

Approval covers post-platinum, post-immunotherapy patients and excludes HPV-associated oropharyngeal disease

The subcutaneous single-agent therapy is cleared for adults whose disease progressed on or after platinum-based chemotherapy and an anti-PD-(L)1 antibody. The indication excludes patients with HPV-associated oropharyngeal squamous cell carcinoma (OPSCC). J&J says it is the first dual-targeted therapy approved in this setting, hitting both EGFR and MET, and describes it as the first advance in second-line treatment of the disease in a decade.

Shanghai – November 06, 2026 -- China's Center for Drug Evaluation (CDE) accepted Lynk Pharmaceuticals' New Drug Application for zemprocitinib in moderate-to-severe active rheumatoid arthritis (RA) on November 4, moving the oral JAK1 inhibitor into regulatory review.

430-patient Phase III trial beat placebo at p<0.0001

The filing rests on a randomized, double-blind, placebo-controlled, multicenter Phase III trial in China. It enrolled 430 adults with moderate-to-severe active RA who had an inadequate response or intolerance to prior biologic disease-modifying antirheumatic drugs (bDMARDs). Zemprocitinib showed statistically significant efficacy over placebo on the primary and key secondary endpoints (p<0.0001). Lynk reports an overall favorable safety and tolerability profile.

LEXINGTON, Mass. – November 05, 2026 -- Curis, Inc. (NASDAQ: CRIS) will report third-quarter 2026 financial and operating results on Thursday, November 12, 2026, at 4:00 p.m. ET, with a conference call and webcast following at 4:30 p.m. ET.

Curis ties acute myeloid leukemia expansion to new funding

The company's monotherapy and combination studies of emavusertib in acute myeloid leukemia (AML) are substantially complete. Curis plans to continue AML development only with additional funding, which makes the November 12 update a checkpoint on its financial position.

PLYMOUTH MEETING, Pa. – November 05, 2026 -- INOVIO Pharmaceuticals (Nasdaq: INO) plans to raise capital through an underwritten public offering of its common stock, with all shares sold by the company itself.

Underwriters hold a 30-day option on up to 15% additional shares

INOVIO intends to grant the underwriters a 30-day option to buy additional shares, capped at 15% of the shares sold in the base offering and priced on the same terms. The company has not disclosed the number of shares or the pricing. It said there is no assurance the offering will be completed, or on what size or terms, and that it remains subject to market conditions.

Jefferies and Piper Sandler are acting as joint book-running managers.

Houston – November 05, 2026 -- ImmunoGenesis has published two papers reporting nonclinical evidence that its STING agonist IMGS-203 remodels the tumor microenvironment and can be combined with the company's cytotoxic dual-specific PD-L1/PD-L2 antibody. The clinical-stage biotech plans to take IMGS-203 into clinical development first in recurrent glioblastoma (GBM).

IMGS-203 reduces immunosuppressive cells and improves survival in tumor models

Nonclinical studies show that local administration of IMGS-203 remodels the tumor microenvironment (TME) and reduces immunosuppressive myeloid cell populations. It also enhances T-cell activation and improves survival in tumor models.

GBM is a highly immunosuppressive, myeloid-rich tumor in which conventional immune checkpoint inhibitors have shown limited efficacy as monotherapy.

Berlin – November 05, 2026 -- Germany's pharmaceutical lobby BPI says the country's healthcare system is neither crisis-proof nor crisis-resilient, as external shocks collide with structural weaknesses in both the industry base and patient supply. BPI Managing Director Dr. Kai Joachimsen made the assessment at the FORUM-Institut's annual health policy conference, "Pharma Trends 2027".

Joachimsen lists five pressure points behind the "polycrisis"

He cited trade conflicts, a dependence on Asia that is still tending to grow despite repeated warnings, fragile supply chains, cyberattacks, and scarce, expensive energy and raw materials.

Joachimsen argued that policy has not matched the threat level. In his view, health policy is location policy and must now also function as security policy.