Deals and Financings

ProfoundBio, a Seattle ADC company with an R&D facility in Suzhou, will be acquired by Copenhagen’s Genmab A/S in a $1.8 billion all-cash deal (see story). The acquisition will expand Genmab’s drug portfolio, including three ProfoundBio clinical stage ADC candidates for solid tumors. The company’s three clinical stage assets target ovarian cancer and other FRα-expressing solid tumors. A privately owned company, ProfoundBio raised $112 million in a B Round financing earlier this year. ProfoundBio is led by CEO Baiteng Zhao, a former associate director at Seagen, a Seattle ADC company that was acquired by Pfizer for $43 billion in 2023. 

Shanghai's Visen Pharma announced plans to stage an IPO on the Hong Kong Exchange. The company will use the proceeds to support its portfolio of three clinical stage rare disease endocrine therapies, including growth hormone deficiency (see story). In 2018, Visen was formed by Ascendis Pharma A/S of Denmark to bring its therapies to China. Ascendis partnered the venture with an investor syndicate led by Vivo Capital and Sofinnova that contributed $40 million in capital for a 50% stake. In 2021, Visen closed a $150 million Series B financing led by Sequoia China. 

Insilico Medicine, an AI drug discovery-development company based in Hong Kong and New York, has completed an initial filing for a Hong Kong IPO (see story). Insilico has developed several platforms that use generative AI to analyze biology, chemistry and clinical trials for next-gen AI systems. Formed in 2014, Insilico develops products for its own portfolio and out-licenses other candidates, while retaining their intellectual property. Two years ago, the company bragged that it needed only 30 months to move its lead drug from discovery to clinical trials at a cost of $2.5 million. 

China Medical System in-licensed povorcitinib, an oral JAK1 inhibitor, from San Francisco’s Incyte (NSDQ: INCY) for autoimmune and inflammatory dermatologic diseases (see story). The candidate will be developed by CMS’s medical aesthetic subsidiary, CMS Skinhealth. The company will have rights to povorcitinib, a small molecule JAK1 inhibitor, in Greater China and eleven Southeast Asian countries, plus a non-exclusive license to manufacture the product for its territories. In late 2022, CMS acquired Greater China rights to another Incyte candidate, ruxolitinib cream, a novel cream formulation of the company’s selective JAK inhibitor ruxolitinib, also for autoimmune and inflammatory dermatologic diseases. 

Company News

Aurisco Pharmaceutical has completed the expansion of its cGMP peptide manufacturing site in Yangzhou that will offer multi-metric ton capacity to produce the company’s generic GLP-1 peptides (see story). The facility, which expects to start operations in mid-2024, will initially pursue commercial scale validation of recombinant Semaglutide. The site also offers CRDMO services for synthetic and recombinant peptides and oligonucleotides. Established in 1998, Aurisco is headquartered in Zhejiang Tiantai, with an R&D center in Shanghai and facilities in Yangzhou, Tiantai, Hangzhou and Tianjin. 

Trials and Approvals

Suzhou’s Innovent Biologics and HutchMed of Shanghai filed an NDA in China for a combination therapy aimed at advanced endometrial cancer (see story). The trial tested Innovent’s sintilimab, an approved PD-1 immunoglobulin G4 mAb, and HutchMed’s fruquintinib, an approved VEGFR inhibitor. The NDA seeks China approval of the combination for advanced endometrial cancer company with pMMR[1] or non-MSI-H[2] tumors that have failed a prior systemic therapy. Patients must not be candidates for curative surgery or radiation. China’s National Medical Products Administration will review the application under Priority rules. 

Zai Lab highlighted news that its partner Bristol Myers Squibb completed a pivotal Phase III trial showing Krazati® (adagrasib) was effective as a monotherapy in patients with NSCLC that harbors a KRASG12C mutation (see story). Zai Lab added China data to the Phase III trial. In 2021, Zai Lab acquired China rights to adagrasib from Mirati Therapeutics in a $338 million ($60 million upfront) deal. Mirati was bought by BMS in 2023. Zai Lab expects to file an NDA in China later this year for adagrasib as a second or later line therapy in patients with KRASG12C mutated NSCLC. 

Jiangsu Ractigen Therapeutics dosed the first patient in a Phase I trial of its lead candidate, a small activating RNA (saRNA) therapy for non-muscle invasive bladder cancer (NMIBC) (see story). RAG-01 is a novel saRNA medication that activates the p21 tumor suppressor gene to treat NMIBC. The trial, being conducted in Australia by GenesisCare, will enroll NMIBC patients who have failed Bacillus Calmette-Guérin (BCG) therapy. Ractigen develops saRNA drugs using RNA to up-regulate endogenous gene expression and restore normal protein functions. 

Taiwan’s PharmaEssentia reported positive data from studies of its ropeginterferon alfa-2b (BESREMi^®) therapy in patients with polycythemia vera (PV), a type of chronic leukemia (blood cancer) that causes bone marrow to overproduce red blood cells (see story). The company said a 250–350–500 µg dosing regimen had the highest probability of a complete hematologic response with acceptable safety. The data was from an exposure-response analyses of the drug. PharmaEssentia published the results in the British Journal of Clinical Pharmacology. 

Yantal’s RemeGen was granted Fast Track Designation in the US for its novel BLyS/APRIL dual-target fusion protein candidate for primary Sjögren's syndrome (pSS) (see story). The candidate, telitacicept, is designed to inhibit the overexpression of two cytokines, B-cell lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL). RemeGen says the two-pronged approach prevents abnormal differentiation and maturation of B-cells, treating various autoimmune diseases mediated by B-cells. A Phase III clinical trial for this indication is currently underway in China. Telitacicept was approved to start US trials in late 2023. 

Disclosure: none.