Biopharmaceuticals

Shanghai – September 11, 2026 -- Alebund Pharmaceuticals (Jiangsu) Limited (HKEX: 09637) has received U.S. FDA clearance of its Investigational New Drug application for AP308, a first-in-class engineered recombinant IgA protease targeting IgA Nephropathy (IgAN), moving the candidate from preclinical research into clinical development.

AP308 targets a disease affecting 9.5 million people worldwide

IgAN is the most common primary glomerulonephritis globally, with an estimated 9.5 million patients in 2025, including 5.1 million in China, more than half of the global total, according to China Insights Consultancy. Under current treatment strategies, median kidney survival is approximately 11 to 12 years, and roughly 60% of patients in a Chinese cohort progressed to end-stage renal disease within 15 years of diagnosis, per long-term studies in China and the UK.

San Diego – September 11, 2026 -- Inhibrx Biosciences reported that its OX40 agonist INBRX-106, combined with pembrolizumab, produced a 48.3% confirmed objective response rate in first-line head and neck squamous cell carcinoma patients, nearly double the 26.5% seen with pembrolizumab alone.

Phase 2 data show the combination therapy nearly doubles response rates versus standard treatment

The randomized Phase 2 portion of the HexAgon study enrolled 68 patients across more than 80 sites in the United States, Europe and Asia, with 63 evaluable for the primary endpoint. Four patients (13.8%) on the combination arm achieved complete responses, compared with zero in the pembrolizumab-only control arm. Six-month progression-free survival reached 72.4% for the combination versus 42.8% for monotherapy, with median PFS of 9.6 months versus 4.9 months as of the August 19, 2026 data cutoff.

Yongin, South Korea – September 11, 2026 -- GCCL (Global Clinical Central Lab), a South Korea-based clinical trial sample analysis provider, sponsored the Asia Bio Partnering Forum 2026 (ABP 2026) as a Platinum Sponsor, using the Singapore event to pursue expansion of its assay development and clinical sample analysis services across the Asia-Pacific region.

GCCL held partnering meetings with drug developers across mRNA, radiopharmaceutical and antibody therapy segments

The forum, held in Singapore from August 31 to September 2, drew approximately 650 pharmaceutical and biotechnology industry professionals, investors and life sciences stakeholders, generating roughly 2,500 one-on-one partnering meetings. GCCL engaged drug developers working across mRNA and nucleic acid therapeutics, radiopharmaceuticals and antibody-based therapies to assess evolving analytical requirements in global clinical development.

Irvine, California – September 10, 2026 -- PeproMene Bio, Inc. reported that seven of nine patients (80%) treated with its BAFF-R-targeted CAR-T therapy PMB-CT01 achieved complete remission in a Phase 1 trial, with results now published in The Lancet.

All complete responses remained relapse-free at data cutoff, with the longest sustained remission reaching 35 months

Four of six patients who had previously progressed after conventional CD19-directed CAR-T therapy also achieved complete response under the new BAFF-R approach, described in the study as "CAR after CAR" treatment. No relapses were observed among any of the seven complete responders as of the data cutoff.

Gothenburg – – September 10, 2026 -- Epicyt Pharma AB reported positive topline results from a Phase 1/2a first-in-human study of its oral drug candidate BAFA, showing a statistically significant reduction in urinary calcium excretion in patients who underwent Roux-en-Y gastric bypass (RYGB) surgery. The Gothenburg-based clinical-stage biopharmaceutical company said the trial, completed in March 2026, also recorded improvements in key biomarkers of calcium homeostasis, consistent with enhanced intestinal calcium uptake.

BAFA targets a market of 3.5 million patients across the EU and US

Epicyt estimates that approximately 3.5 million people in the EU and US currently live with impaired calcium homeostasis following bariatric surgery, with roughly 250,000 new patients added annually. RYGB is widely used to treat severe obesity but frequently impairs calcium uptake, raising the risk of secondary hyperparathyroidism, reduced bone density and fractures.

Yongin, South Korea – September 10, 2026 -- GCCL (Global Clinical Central Lab), a South Korea-based clinical trial sample analysis provider, served as a Platinum Sponsor at the Asia Bio Partnering Forum 2026 (ABP 2026) in Singapore, held from August 31 to September 2, as it pursued expansion of its assay development and sample analysis services across the Asia-Pacific region.

ABP 2026 drew 650 industry professionals and 2,500 one-on-one partnering meetings

The forum brought together approximately 650 pharmaceutical and biotechnology executives, investors and life sciences stakeholders, with roughly 2,500 one-on-one partnering meetings held over three days. GCCL used the event to hold discussions with drug developers, contract research organizations (CROs) and regional stakeholders from Korea, China, Japan, Singapore, Vietnam and Europe.

Los Angeles – September 10, 2026 -- DJS Law Group has reminded shareholders of a class action lawsuit filed against Beta Bionics, Inc. (NASDAQ: BBNX) alleging violations of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934. The suit covers investors who purchased BBNX shares between July 30, 2025 and February 24, 2026, with a lead plaintiff filing deadline set for November 3, 2026.

Complaint alleges Beta Bionics downplayed FDA findings on its iLet insulin pump

The complaint centers on the iLet Bionic Pancreas insulin pump, Beta Bionics' sole commercialized product. After the company disclosed that the FDA had issued a Form 483 following a manufacturing facility inspection, defendants allegedly told investors the agency's observations were limited to complaint-reporting criteria and did not reflect underlying device problems.

Sheridan, Wyo. – September 10, 2026 -- The global stem cells market is projected to expand from USD 18.9 billion in 2026 to USD 32.57 billion by 2031, growing at a compound annual rate of 11.5%, according to a new study by Wissen Research.

Manufacturing gains, not new discoveries, drive the current growth phase

Analysts say the market's momentum stems largely from improvements in how cells are harvested, cultured, isolated, expanded and cryogenically preserved, rather than from newly identified therapeutic uses. Induced pluripotent stem cells (iPSCs) are drawing particular attention because they can be generated from adult tissue, avoiding sourcing and ethical issues tied to embryonic cells. Allogeneic, donor-derived therapies are also gaining share because they allow bulk, off-the-shelf manufacturing instead of custom batches per patient.

Bangkok -- September 7, 2026 -- Wooree Group, a South Korean biotechnology and lighting conglomerate with 60 years of history, has called for a scientific validation standard for the liposomal health products market, following its participation in Vitafoods Asia 2026 held September 2-4 in Bangkok.

Seoul – September 09, 2026 -- The Ministry of Food and Drug Safety of Korea (MFDS) concluded the 12th Global Bio Conference (GBC) on August 28, drawing roughly 5,600 participants from 19 countries to the Grand InterContinental Seoul Parnas for three days of talks on biopharmaceutical regulation and technology.

Forums drew hundreds of specialists across vaccines, proteins and advanced therapies

Held from August 26-28 under the theme 'The Great Leap in Bio, Accelerating Innovation,' the event featured 75 biopharmaceutical experts delivering presentations across specialized tracks. The Recombinant Protein Products Forum attracted 591 attendees, the Advanced Biopharmaceuticals Policy and Quality Forum drew 483, and the Vaccine Forum logged 462 participants, combining online and offline sessions.