GlaxoSmithKline

WHO prequalifies tafenoquine, the first single-dose treatment for preventing relapse of P. vivax malaria, co-administered with chloroquine. This milestone includes guidelines for both adults and children aged 2+ years, addressing the disproportionate burden of relapsing malaria in children. Tafenoquine's inclusion in WHO's updated malaria guidelines marks a significant step towards closing the treatment gap for P. vivax malaria.

Hansoh Pharmaceutical Group's ADC HS-20093, targeting B7-H3, approved as Breakthrough Therapy by NMPA for ES-SCLC, also approved by US FDA. HKG entered a license agreement with GSK for HS-20093. Hansoh transformed from generics to innovative drugs, with 75% of revenue from innovative medicines. Collaborations with GSK, AMGEN, and others drove RMB1.4bn in H12024 revenue. Hansoh's R&D investment increased to 20.8% of total sales, with over 50 clinical trials for 30 innovative drugs. Stock price up 20% YTD, trading at P/E of 25.4x, with analysts' average target price suggesting 20% upside potential.

Chinese pharmaceutical and bio industry's technology exports surged to 80 cases in 2022, nearly doubling from 41 in 2021. Major deals include Merck's $9.475 billion investment in Kelun's ADC technology and J&J's CAR-T therapy 'Carvykti' developed with Legend Biotech. FDA approvals for Chinese drugs like Junshi Biosciences' 'Toripalimab' and Bio-Thera Solutions' 'Avitinib' highlight China's growing influence in global bio market.

Tonix Pharmaceuticals announces strategic hires of Bradley Raudabaugh, MBA as VP Marketing, and Errol Gould, Ph.D. as VP Medical Affairs, to support TNX-102 SL launch for fibromyalgia. NDA submitted in Oct 2024, FDA acceptance expected Dec 2024, decision in 2025. TNX-102 SL could be the first new fibromyalgia drug in 15+ years.

The global red biotechnology market was valued at USD 405.84 billion in 2024 and is projected to reach USD 649.31 billion by 2033, growing at a CAGR of 5.36%. Key drivers include advancements in gene therapy, monoclonal antibodies, and immunotherapy, as well as increased funding for R&D. Regulatory challenges and high costs remain significant constraints.

The global Small Molecule Drug Discovery Market is growing due to outsourcing to CROs and increased R&D in the pharmaceutical industry. The market is expected to reach $106.77 billion by 2031 from $50.93 billion in 2023 at a CAGR of 9.7%. Key players include Bristol-Myers Squibb, Merck, GSK, Boehringer Ingelheim, Thermo Fisher Scientific, ICON, Danaher, Charles River Laboratories, Oncodesign Services, and Revvity Inc.

The FDA accepted GSK's BLA for Blenrep in combination with bortezomib plus dexamethasone (BVd) and pomalidomide plus dexamethasone (BPd) for relapsed or refractory multiple myeloma, supported by Phase III DREAMM-7 and DREAMM-8 trials. Blenrep combinations showed clinically meaningful improvements in efficacy endpoints, with manageable side effects. The FDA action date is set for July 23, 2025.

Belantamab mafodotin's comeback, FDA approvals for subcutaneous daratumumab-hyaluronidase and expanded CAR T-cell products, and isatuximab-based quadruplet emerging as new standard for transplant-ineligible newly diagnosed multiple myeloma patients.

The FDA accepted a BLA for belantamab mafodotin (Blenrep) combinations with bortezomib and dexamethasone (BVd) and pomalidomide and dexamethasone (BPd) for multiple myeloma. Supported by phase 3 DREAMM-7 and DREAMM-8 trials, these combinations showed significant PFS improvements. The FDA target action date is July 23, 2025.