Eyes on Asia: Sanofi expands China footprint; Takeda buys anemia asset

Sanofi earmarks $1 billion for new Beijing insulin plant

Sanofi plans to spend $1 billion to build a new insulin manufacturing facility in Beijing, the company’s fourth manufacturing plant in China.

Sanofi will build the insulin production facility in Beijing E-Town, where it already has a plant that also manufactures insulin products.

The new facility scored a first-ever for a foreign biopharma: it will be the first time an international pharma has built a biotherapeutic active pharmaceutical ingredients (API) production plant in China. Once completed, the factory will supply biological raw materials for insulin therapies in Sanofi's other E-Town factory.

Working together, the two facilities will supply insulin to China’s very large population of diabetes patients. Nearly one‐quarter of the world’s diabetes cases are found in China, according to a National Institute of Health (NIH) study.

The Administrative Committee of the Beijing Economic-Technological Development Area (BDA), which had a hand in landing Sanofi’s new facility, issued a press release that made clear that international companies are welcome in Beijing, that they are, in fact, important to Beijing’s growth.

The BDA release said: “The medical and health industry is one of the 'two engines' driving Beijing's innovative development. This year, Beijing has implemented the third round of accelerated medical health co-innovation action plans, introducing 32 measures to support innovative drug development, providing a superior development environment for multinational pharmaceutical companies to land and increase their investments.”

Sanofi CEO Paul Hudson added that the new production facility will use high-standard automated production, top-tier digital integrated management, and sustainable environmental standards to ensure consistent production levels.

Since opening its first office in China in 1982, Sanofi has built three production sites and four R&D centers. Its operations include pharmaceuticals, human vaccines, and consumer healthcare. The existing site in E-Town is Sanofi's largest insulin injection production base in the Asia-Pacific region. The facility makes products to treat diabetes, cardiovascular disease, internal medicine, and oncology.

Takeda antes up $200 million for anemia candidate

Takeda bought global rights (ex-China) for an anemia drug candidate from Keros Therapeutics for $200 million upfront.

Elritercept is a late-stage investigational activin inhibitor that targets activin A and B proteins. It is designed to treat anemia associated with hematologic cancers, including myelodysplastic syndromes (MDS) and myelofibrosis (MF). Takeda will have rights to develop, manufacture, and commercialize elritercept worldwide.

In addition to the $200 million upfront payment, Takeda will pay up to $1.1 billion to Keros in milestone payments plus royalties on net sales. Keros is located in a Boston suburb.

Keros describes elritercept as an engineered ligand trap. It is comprised of a modified ligand-binding domain of the TGF-ß receptor known as activin receptor type IIA, which is fused to a portion of the human antibody known as the Fc domain.

Takeda #said elritercept would add to its portfolio of therapies for hematologic cancers.

The US Food and Drug Administration (FDA) has granted fast track designation for elritercept in patients with very low-, low- and intermediate-risk myelodysplastic syndromes (MDS). MDS and myelofibrosis (MF) are characterized by inadequate blood cell production, often leading to severe anemia.

In early clinical studies, elritercept has shown promising clinical activity and a manageable safety profile in the target population, according to Keros.

Elritercept is currently in two ongoing Phase II clinical trials; one in patients with very low-, low- or intermediate-risk MDS and one in patients with MF. The Phase III RENEW trial evaluating elritercept in adult patients with transfusion-dependent anemia with very low-, low- or intermediate-risk MDS will begin enrollment soon.

MDS are a group of blood cancers in which the bone marrow fails to produce enough healthy blood cells. MF is a rare and life-threatening blood cancer characterized by the buildup of scar tissue in the bone marrow, which impairs its ability to produce normal blood cells.

Angitia finds backing for musculoskeletal therapies

Angitia Biopharma completed a $120 million Series C financing to support clinical trials of three novel candidates for musculoskeletal diseases.

The company is advancing two bispecific candidates, each one a dual targeting combination of sclerostin and DKK1, to treat osteoporosis and osteogenesis imperfecta (OI). OI, also known as brittle bone disease, is a genetic disorder that affects young people and causes bones to break easily.

Although both targets of the bispecific are known to effective, Angitia believes its dual mechanism candidates will offer better care of skeletal disease, increasing bone formation and decreasing bone resorption.

Earlier this year, Angitia announced that AGA2118 led to rapid and durable increases in bone formation, decreases in bone resorption, and improvements in bone mineral density (BMD) and bone strength. The results came from a Phase I trial that enrolled healthy participants.

The company has been consistently able to raise funds since its beginning in 2018. It added $156 million in a Series B round (with two extensions).

The C round was led by Bain Capital Life Sciences, with participation from new investor Janus Henderson and existing Chinese investors OrbiMed, 3H Health Investment, Yonghua Capital, Legend Capital, and Elikon Venture.

Angitia was originally founded in Guangzhou, China, which remains a part of the company’s operations, though its headquarters are now located in Woodland Hills, California.

The company’s Phase III drug candidate is AGA111, a biologic that promotes spinal fusion in patients with degenerative disc disease. The candidate’s Phase III trial is being conducted in China and the US.

DualityBio sells option for early-stage candidate to GSK

Duality Biologics (DualityBio) snagged $30 million by selling an option to GSK for a preclinical asset, an antibody drug candidate (ADC) known as DB-1324.

The candidate is a next-gen ADC aimed at a gastrointestinal (GI) cancer target. DualityBio believes DB-1324 has the potential to be a best-in-class ADC drug for GI disease, currently an unmet need.

GSK has an option to develop and commercialize DB-1324 worldwide (excluding greater China). DualityBio says the molecule could offer multiple combination therapies when paired with GSK's oncology portfolio. If GSK exercises the option, it will pay DualityBio up to $975 million in a combination of an option-exercise fee plus development and sales-based milestone payments.

Because GSK is carrying most of the clinical development burden, it will be eligible to receive milestone payments from DualityBio based on greater Chinese development and sales.

DualityBio, a Shanghai company, is an active dealmaker. The company lists seven assets discovered using its Duality Immune Toxin Antibody Conjugate (DITAC) platform. It has sold global (ex-China) rights for three of them to BioNTech and a fourth to BeOne (formerly known as BeiGene).

BeOne signs deal for CSPC solid tumor asset

BeOne (the new name for BeiGene) acquired global rights to a novel candidate for solid tumor cancers developed by CSPC Pharmaceutical Group.

SYH2039 is a preclinical asset that targets solid tumors with an MTAP deletion mutation, a condition estimated to be in about 15% of all cancer types including glioblastoma, pancreatic cancer, and non-small cell lung cancer.

SYH2039 is a MAT2A inhibitor that is expected to cause synthetic lethality in MTAP-deleted cancers. BeOne believes the MAT2A inhibitor could also be an effective combination therapy with the company’s internally developed PRMT5 inhibitor, BGB-58067.

BGB-58067 is designed to avoid on-target hematological toxicity, which was found with first-generation PRMT5 inhibitors. BeOne claims the candidate has best-in-class potential with high potency, selectivity, and brain penetrability. The company plans to start trials of BGB-58067 before the end of the year.

BeOne will make upfront payments of $150 million to CSPC for the candidate, another $135 million in milestone payments, and up to $1.5 billion in sales milestones.

For BeOne, the CSPC asset adds to its portfolio of solid tumor drugs, including its PD-1 inhibitor Tevimbra (tislelizumab) and other potential best-in-class assets for lung, breast and gastrointestinal cancers.