Deals and Finances
WuXi Biologics (HK; 2269) and WuXi AppTec (OTCPK: WUXIF ) (OTCPK: WUXAY ) (SHA: 603259 ) announced that each company will invest $1.4 billion over ten years to build R&D and manufacturing facilities in Singapore. The sites will offer CRDMO (Contract Research, Development and Production organization) services for the customers of each company. Over the past few years, both companies have invested heavily to expand their physical presence around the world while implementing new technologies. Their respective CEOs characterized the Singapore expansion as the next logical step in their continued global growth. Although the two companies are separate, they both operate under the umbrella of WuXi PharmaTech.
Frontera Therapeutics, a Boston-Suzhou gene therapy company, has completed a $160 million Series B financing to support its AAV programs ( see story ). The company also announced US approval to begin clinical trials of its lead drug, FT-001, a recombinant AAV gene therapy for hereditary retinopathy caused by an RPE65 gene mutation. Frontera targets orphan diseases and larger patient markets in ophthalmology, hematology, neurology and metabolic diseases. Investors in the round include Boyu Capital, Sequoia China, and existing investors OrbiMed and Creacion Ventures, who co-led the Series A round. To date, Frontera has raised $195 million.
Hong Kong’s NeuroFront Therapeutics has acquired major Chinese rights to a new non-opioid drug for neuropathic pain from Switzerland’s Novaremed in a $130 million deal. NeuroFront, a company focused on innovative CNS drugs, will initially develop NRD.E1 for the treatment of neuropathic pain associated with diabetes. It will pay $130 million in options and principal payments for commercialization and production rights, plus sales royalties. The company must exercise its license option no later than the completion of the phase IIb trial of NRD.E1 in PDPN, which will begin enrolling patients in the next few weeks.
Beijing Luzhu Biotechnology has filed for an IPO in Hong Kong with plans to spend 40% of the proceeds on its lead product LZ901, a shingles vaccine candidate aimed at preventing shingles in adults over 50. Although it was founded in 2001 to produce new vaccines, the company has built a portfolio of vaccines that also includes an adalimumab biosimilar and two bispecific leukemia antibodies that will soon begin testing. Luzhu expects to file an NDA for the shingles vaccine in the second quarter of 2024.
Germany’s Merck KGaA has announced that the Uptune program will support Asian start-ups with up to €100,000 each to advance their projects into proof-of-concept studies. The program will seek innovative healthcare technologies with AI and cell/gene therapy along with technologies and materials in semiconductors and smart manufacturing. Merck expects to include up to five companies. The company already has a China Accelerator program that has funded 30 life science startups with €50,000 each over the past three years. 60% of start-ups have established a collaboration with Merck.
Tests and approvals
Simcere Pharma (HK: 02096) was conditionally approved to market Cosela® to reduce myelosuppression in patients who have been treated with platinum/etoposide for extensive-stage small cell lung cancer (see story). Cosela, a first-in-class drug, has a reversible CDK4/6 inhibitor that puts CDK4/6-dependent cells (hemopoietic stem and progenitor cells) into temporary arrest in the G1 phase of the cell cycle, reducing damage during chemotherapy. In 2020, Simcere licensed the Chinese rights to Cosela from North Carolina-based G1 Therapeutics ( GTHX ) in a $170 million deal. The drug was approved for use in the US last year.
Ascentage (HK:68550) and Innovent (HK:01801) (OTCPK:IVBIY) announced that their third-generation TKI partner has been accepted for NDA review in China under the priority rules following a Phase II study in patients with chronic phase of chronic myeloid leukemia (CML-CP). The NDA supports the full approval of olverembatinib in patients with CML-CP who are resistant or intolerant to first- and second-generation tyrosine kinase inhibitors. In July 2021, Ascentage and Innovent partnered to co-commercialize olverembatinib in China in a three-part deal valued at $245 million. Both Innovent and Ascentage are headquartered in Suzhou.
Suzhou Innovent (HK: 01801) reports that its dual agonist therapy met its primary endpoint of lowering glycemic levels in a double-blind Phase II study in China involving patients with type 2 diabetes. Innovent’s mazdutide, once-injected weekly, combines glucagon-like peptide-1 receptor and glucagon receptor. The study compared mazdutide with placebo and with Lilly’s Trulicity (dulaglutide). Lilly also developed mazdutide and partnered with Innovent as part of their global collaboration that began when Lilly partnered with Innovent’s PD-1 candidate. Lilly is testing mazdutide outside of China.
Shenzhen ImmVira announced that its IV oncolytic herpes simplex virus (oHSV) therapy showed promising biodistribution after completion of the first three dose escalations in a US study involving patients with solid tumors. The trial tested doses from 1×106 to 1×108 PFU on 10 subjects. MVR-T3011 is a novel genetically engineered oHSV (herpes virus) that uses attenuated HSV-1 for best replication efficiency and safety. The candidate is oHSV 3 in 1 containing both PD1 mAb and IL12. ImmVira says MVR-T3011 is a next-generation design based on its insights into oncolytic viruses and gene recombinant technology.
Shanghai Antengene (HK:6996) will conduct preclinical tests that combine its bispecific cryopreserved human placental hematopoietic stem cell-derived natural killer (NK) cell therapy developed by Celularity of New Jersey (CELU) ( see story ). Celularity develops allogeneic cryopreserved, off-the-shelf cell therapies that include unmodified NK cells, genetically engineered NK cells, CAR T cells, and mesenchymal-like adherent stromal cells (ASCS). They are aimed at indications in cancer, infectious and degenerative diseases. Antengene is developing a bispecific PD-L1/4-1BB candidate that has been approved to initiate trials in the US for solid tumors and non-Hodgkin’s lymphoma.
Editor’s note: The summary points for this article were selected by the editors of Seeking Alpha.