Image Source: Kevin Smith on Flickr

Deals and Financings

ArriVent BioPharma (AVBP), a Philadelphia in-licensing company, priced its upsized Nasdaq IPO at $18 dollars per share, raising $175 million (see story). The company’s stated goal is to find promising novel assets from China and other countries, which it aims to bring to the US market.

ArriVent’s lead product is furmonertinib, an EGFR TKI with best-in-class potential that it acquired from Shanghai's Allist Pharma. ArriVent has also partnered with San Francisco’s Aarvik Therapeutics to discover a novel molecule for an unspecified target. Much of ArriVent’s funding came from China investors including Hillhouse, Lily Asia and OrbiMed. 

China's Jiuzhou Pharma will invest $42 million to expand its CDMO business by building a facility in Japan. Zhejiang Jiuzhou Pharma is a CDMO that evolved from a generic API company (see story). The company’s CDMO subsidiary, Raybow Life Sciences, is headquartered in Singapore with facilities in China, the US, and EU.

It offers small molecule R&D and green chemical manufacturing. The parent company, Jiuzhou Pharma, claims to be the top API global manufacturer and supplier of Carbamazepine, a treatment for seizures. Jiuzhou was founded in 1998 and is headquartered in Taizhou, Zhejiang Province. 

Jiangsu Alphamab Oncology and its partner, 3D Medicines of Beijing, announced an out-licensing agreement for their approved subcutaneous injection PD-L1 inhibitor, envafolimab, with Glenmark Specialty SA (GSSA) of India (see story). GSSA will have exclusive rights to develop, register, and commercialize envafolimab in India, Asia Pacific, Middle East and Africa, Russia, CIS, and Latin America.

In 2021, envafolimab was the global-first subcutaneous injection PD-L1 inhibitor approved. It was indicated as a second-line therapy for microsatellite instability-high (MSI-H) or deficient MisMatch repair (dMMR) solid tumors. Over 30,000 patients in China been treated with envafolimab. 

Biocytogen Pharma (Beijing) launched a new sub-brand, RenBiologics, that will be in charge of its antibody discovery business division (see story). RenBiologics will be responsible for out-licensing and co-development of the company’s library of fully human antibodies, as well as licensing RenMice, the company’s fully human antibody/TCR discovery platforms.

Based on gene editing technology, Biocytogen uses its genetically engineered proprietary RenMice platforms to discover fully human monoclonal/bispecific/multispecific antibodies, bispecific antibody-drug conjugates, nanobodies, and TCR-mimic antibodies. Biocytogen regularly announces agreements with biopharmas for its products, though it does not disclose their financial details.  

Trials and Approvals

A siRNA therapy developed by Shanghai Refreshgene Therapeutics enables children with genetic deafness to hear (see story). In a China-US trial, six children, aged one to seven, were able to hear for the first time after a single dosing of an siRNA therapy that used an adeno-associated virus (AAV) to deliver a functioning copy of the human otoferlin gene to previously deaf children.

The therapy was effective in five out of the six patients. In the five patients who responded, all were able to hear after a few months and also learned how to speak. The trial results were published in the Lancet on Wednesday. 

Beijing InnoCare has been approved to launch tafasitamab (Minjuvi) under an early access program to treat patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (see story). Tafasitamab, a CD19 targeting immunotherapy, will be administered in combination with lenalidomide and will be available in the Guangdong-Hong Kong-Macao Greater Bay Area.

InnoCare has completed patient enrollment in a China registrational trial of the combination therapy, and it expects to submit the biologics license application (BLA) in the second quarter of 2024. 

Shanghai Gannex announced that its partner, Sagimet Biosciences (SGMT), reported positive topline results from a US Phase IIb clinical trial of denifanstat in patients with non-alcoholic steatohepatitis (NASH) (see story). Denifanstat, an oral, selective FASN inhibitor, showed statistically significant improvements compared to placebo on both of the primary endpoints of NASH resolution without worsening of fibrosis.

In 2019, Ascletis (ASCLF), the parent of Gannex, acquired China rights to the drug from California’s Sagimet Biomed. Gannex focuses on the R&D and commercialization of novel NASH therapies with three clinical stage candidates aimed at three targets — FASN, THRβ, and FXR — and three combination therapies. 

Guangzhou Baird Medical performed its first thyroid microwave ablation (MWA) procedure in the US (see story). A China-US company, Baird’s MWA device is used to treat benign and malignant tumors including thyroid nodules, liver cancer, lung cancer, and breast lumps. It is the first company awarded a Class III medical devices registration certificate in China for MWA medical devices that target thyroid nodules.

Baird Medical says it has a 35% market share of microwave ablation devices in China. The company is approved for China and US use in MWA procedures for thyroid nodules. 

Suzhou DualityBio and its partner, BioNTech (BNTX) of Germany, have dosed the first metastatic breast cancer patients in a global pivotal Phase III trial of BNT323/DB-1303, a novel antibody-drug conjugate candidate targeting HER2 (see story). The trial will assess the efficacy and safety of BNT323/DB-1303 compared to standard-of-care single-agent chemotherapy.

It will enroll chemotherapy-naïve patients with HR+ and HER2-low metastatic breast cancer who have progressed on hormone therapy. In April 2023, BioNTech acquired global (ex-China) rights to DB-1303 and another ADC for $170 million upfront and $1.5 billion in milestones.

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