Pharmaceuticals & Biopharmaceuticals

Singapore – September 21, 2026 -- WuXi XDC Cayman Inc. (2268.HK) has secured GMP release for its Singapore manufacturing site at Tuas Biomedical Park, marking the bioconjugate CRDMO's first overseas facility just two and a half years after the site was announced in March 2024.

BCM3 dual-function line and DP4 drug product facility clear GMP release

The 25,000-square-meter site achieved GMP release for both its BCM3 antibody intermediate and conjugated drug substance production line and its DP4 drug product facility in August 2026. BCM3 supports batch sizes from 200 L to 2,000 L for antibody intermediates and up to 2,000 L for conjugated drug substances, operating under FDA, EMA and NMPA standards. A second line, BCM4, is slated for GMP release by the end of 2026 with a maximum single-batch capacity of 500 L for conjugated drug substance.

Aachen, Germany – September 21, 2026 -- Grünenthal has agreed to acquire Bayer AG's oncology drug Stivarga® (regorafenib) for up to €375 million, adding an oral cancer treatment sold in more than 90 markets to its portfolio.

Grünenthal expects Stivarga to add up to €100 million to EBITDA in 2027

The German pharmaceutical company said the acquisition is immediately accretive to its business, with an estimated positive impact on consolidated EBITDA of approximately €100 million for the year ending December 31, 2027. That projection assumes the deal closes by the end of 2026 or early 2027 and includes a full year of consolidation.

Boston – September 21, 2026 -- Cellular Intelligence, a Boston-based AI company building a universal foundation model of cell signaling, has appointed Turing Award laureate Yann LeCun, Moderna co-founder Robert "Bob" Langer, BioInnovation Institute CEO Jens Nielsen and Helmholtz Munich computational health director Fabian Theis to its Scientific Advisory Board. Langer also joins the company's Board of Directors as an observer.

Melbourne – September 21, 2026 -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX) has signed a strategic agreement to merge with ITM Isotope Technologies Munich SE in a deal valuing ITM at US$1.65 billion upfront on a cash-free, debt-free basis, with up to US$700 million in additional contingent consideration tied to regulatory and sales milestones.

Deal structures $1.25 billion in Telix stock alongside debt assumption

Under the agreement, ITM shareholders will receive approximately US$1.25 billion in the form of 105.8 million Telix shares priced at US$11.84 per share, released as Nasdaq-listed ADRs following escrow periods of up to 15 months. Telix will additionally assume US$302 million of ITM net debt at closing, with US$96 million allocated to management equity rollover and transaction expenses. Upon completion, existing Telix shareholders will hold roughly 76.3% of the combined company, with ITM shareholders holding approximately 23.7%.

Shanghai – September 21, 2026 -- Abbisko Therapeutics Co., Ltd. (HKEX: 02256.HK) reported that its oral FGFR2/3 inhibitor lavengratinib achieved a mean increase of 2.4 cm/year in annualized height velocity among children with achondroplasia in the lowest-dose cohort of a Phase II trial, with a 100% responder rate.

Seven children in the first dose cohort completed six months of treatment with no serious adverse events

All seven participants aged 6 to 12 in cohort 1 of the ABSK061-202 study received lavengratinib at 0.064 mg/kg once daily for 27 weeks. Responders were defined as achieving at least a 25% improvement in annualized height velocity from baseline, a threshold every participant in the cohort met.

Shanghai – September 21, 2026 -- Antengene Corporation Limited (SEHK: 6996.HK) has dosed the first patient in China in its pivotal Phase III CLINCH-3 study evaluating ATG-022, a CLDN18.2 antibody-drug conjugate, as monotherapy for CLDN18.2-positive advanced gastric or gastroesophageal junction adenocarcinoma.

Breakthrough Therapy Designation accelerated the trial's launch

China's National Medical Products Administration granted ATG-022 Breakthrough Therapy Designation, which the company says streamlined regulatory communications and enabled the rapid start of CLINCH-3. The randomized, controlled, open-label multicenter study is initiated in China and planned for expansion into a multi-regional clinical trial, with Professor Lin Shen of Peking University Cancer Hospital serving as principal investigator. The study compares ATG-022 against treatment of investigator's choice, targeting a future marketing approval application.

Singapore – September 21, 2026 -- Specialised Therapeutics (ST) has expanded its partnership with Incyte Biosciences International to commercialise, distribute, and register ruxolitinib cream, marketed as Opzelura, in Australia.

ST gains rights to market Opzelura for vitiligo and atopic dermatitis in Australia

Under the expanded agreement, Incyte will continue to develop and manufacture ruxolitinib cream, a topical Janus kinase (JAK) inhibitor, while ST takes on regulatory submissions, medical affairs, marketing, and distribution across the Australian market. The drug is approved in the U.S. and European Union for treating non-segmental vitiligo and mild-to-moderate atopic dermatitis in patients who do not respond adequately to standard topical therapies.

Shanghai – – September 21, 2026 -- Ten biotech startup teams have been selected as finalists for the inaugural S2S China Symposium, narrowed from roughly 20 semifinalists who competed to pitch global venture investors at Westlake University on October 15.

RA Capital and Qiming Venture Partners co-host China chapter of Science2Startup

S2S China is the China chapter of Science2Startup, an invitation-only program founded in 2018 by F-Prime, SV Health and Atlas Venture that connects academic therapeutics researchers with biotech investors. RA Capital Management, Osage University Partners and 5AM Ventures have since joined the network. The China edition is co-hosted by RA Capital Management and Qiming Venture Partners.

New York and Suzhou, China – September 21, 2026 -- Accro Bioscience Inc. has dosed its first patient in a Phase IIb trial testing AC-101, a selective RIPK2 inhibitor, in patients with moderate-to-severe ulcerative colitis (UC).

Trial spans roughly 50 clinical sites with three treatment arms

The multicenter, double-blind, placebo-controlled study is designed across approximately 50 clinical sites and includes two AC-101 dose cohorts plus a placebo control arm. The primary endpoint is clinical remission rate at Week 12, with exploratory endpoints covering histologic remission and long-term maintenance of clinical and histologic remission.

Rochester, Mich. – September 21, 2026 -- Par Health is voluntarily recalling two lots of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection 400 mcg/100 mL (4 mcg/mL) at the hospital level after detecting particulate matter identified as cellulose or stopper material.

Contaminated vials carry risk of pulmonary emboli and vessel occlusion

The FDA-notified recall covers Lots 87558 and 88802, which were distributed nationwide to wholesalers between September 21, 2026 and September 21, 2026. Par Health warned that administering the affected product carries a reasonable probability of causing life-threatening adverse health consequences, including pulmonary emboli, occlusions of other blood vessels that can lead to tissue death and organ damage, and inflammation of vein walls that may result in clotting. The company said it has not received any adverse event reports tied to the recall to date.