Week In Review: WuXi Biologics And WuXi AppTec Plan $2.8 Billion Investment In Singapore Facilities

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Deals and Financings

WuXi Biologics (2269.HK) and WuXi AppTec (603259.SS) announced that each company would invest $1.4 billion over ten years to build R&D and manufacturing facilities in Singapore (see story). The sites will offer CRDMO (Contract Research, Development, and Manufacturing Organization) services to each companies’ clients.

Over the past few years, both companies have invested heavily to expand their physical presences around the globe while also incorporating new technologies. Their respective CEOs characterized the expansion into Singapore as the next logical step of their continuing growth globally. Although the two companies are separate, both operate under the umbrella of WuXi PharmaTech. 

Frontera Therapeutics, a Boston-Suzhou gene therapy company, completed a $160 million Series B funding 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 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 acquired greater China rights to a novel non-opioid neuropathic pain drug from Switzerland’s Novaremed in a $130 million agreement (see story). NeuroFront, a company focusing on innovative CNS drugs, will initially develop NRD.E1 to treat diabetes-related neuropathic pain.

It will pay $130 million in option and milestone payments for commercialization and manufacturing rights, plus royalties on sales. The company must exercise its license option no later than completion of the Phase IIb trial of NRD.E1 in PDPN, which will start patient enrollment in the next few weeks. 

Beijing Luzhu Biotechnology has filed to IPO in Hong Kong with plans to spend 40% of the proceeds on its lead product LZ901, a herpes zoster vaccine candidate aimed at preventing Shingles in adults over 50 years old (see story).

Although it was founded in 2001 to make new vaccines, the company has built a portfolio of vaccines that also includes an adalimumab biosimilar and two bispecific antibodies for leukemia that are scheduled to start trials soon. Luzhu expects to file an NDA for the herpes zoster vaccine in Q2 of 2024. 

Company News

Merck KGaA of Germany announced its Uptune program will back Asia startup companies with up to €100,000 each to advance their projects into proof-of-concept studies (see story). The program will look for innovative technologies in AI-enabled health and cell/gene therapy along with technologies and materials in semiconductors and smart manufacturing.

Merck expects to enroll up to five companies. The company already has a China Accelerator program that, over the past three years, has funded 30 life science startups with as much as €50,000 each. 60% of the startups formed collaborations with Merck. 

Trials and Approvals

Simcere Pharma (2096.HK) was conditionally approved to market Cosela® to reduce myelosuppression in patients who are 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 (hematopoietic stem and progenitor cells) into temporary arrest at the G1 phase of the cell cycle, reducing damage during chemotherapy.

In 2020, Simcere in-licensed China rights to Cosela from G1 Therapeutics (GTHX) of North Carolina in a $170 million agreement. The drug was approved for US use last year. 

Ascentage (6855.HK)  and Innovent (1801.HK) reported that their partnered third-gen TKI was accepted for China NDA review under Priority rules following a Phase II trial in patients with chronic-phase chronic myeloid leukemia (CML-CP) (see story). The NDA supports full approval of olverembatinib in patients with CML-CP who are resistant or intolerant of first- and second-gen tyrosine kinase inhibitors.

In July 2021, Ascentage and Innovent partnered joint commercialization of olverembatinib in China in a three-part, $245 million deal. Both Innovent and Ascentage are headquartered in Suzhou. 

Suzhou Innovent reported its dual agonist therapy met its primary endpoint by lowering glycemic levels in a double-blind China Phase II trial that enrolled patients with type 2 diabetes (see story). Innovent’s mazdutide, a once-weekly shot, combines glucagon-like peptide-1 receptor and a glucagon receptor.

The trial compared mazdutide to a placebo and to Lilly’s Trulicity (dulaglutide). Lilly also developed mazdutide and partnered it with Innovent as part of their global collaboration, which started when Lilly partnered Innovent’s PD-1 candidate. Lilly is testing mazdutide outside of China. 

Shenzhen ImmVira announced its IV oncolytic herpes simplex virus (oHSV) therapy showed promising biodistribution after completing the first three dose escalations in a US trial that enrolled patients with solid tumor cancers (see story). The trial tested dosages from 1x106 to 1x108 PFU on 10 subjects.

MVR-T3011 is a novel genetic engineered oHSV (herpes virus) that uses attenuated HSV-1 for best replication potency and safety. The candidate is a 3-in-1 oHSV containing both a PD1 mAb and IL12. ImmVira says MVR-T3011 is a next-gen design based on its oncolytic virus insights and gene recombinant technology. 

Shanghai Antengene (6996.HK) will conduct preclinical tests that combine its bispecific with a cryopreserved human placental hematopoietic stem cell-derived natural killer (NK) cell therapy developed by New Jersey’s Celularity (CELU) (see story).

Celularity develops allogeneic cryopreserved, off-the-shelf cell therapies that include unmodified NK cells, genetically-modified NK cells, CAR T-cells, and mesenchymal-like adherent stromal cells (ASCs). They target indications in cancer, infectious and degenerative diseases. Antengene is developing a PD-L1/4-1BB bispecific candidate, which has been approved to start US trials for solid tumors and Non-Hodgkin

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