Sudo Biosciences Secures $116M Series B Financing Backed by Sanofi; Hansoh Pharma Advances Parallel TYK2 Inhibitor HS-10374 Toward Pivotal Trials

The biggest deal in December 2022 was Takeda's $6 billion acquisition of the oral selective TYK2 inhibitor NDI-034858 from Nimbus.

December 2023 can be considered a significant month for ADC BD, with B as of now.MS Reaches $8.4 Billion Deal with Baili Tianhe for Bispecific ADC; Immediately followingNona and Yilian Bio Co-Developed MSLN ADC Acquired by Pfizer for Over $10 Billion in Total; and just yesterday,GSK Reaches Global Pipeline Collaboration on B7H3 ADC HS-20093 with Hansoh Pharma for a Total Amount of $1.71 Billion。

This is already the second ADC transaction event for Hansoh Pharma within two months; the first B7H4 ADC transaction was also licensed to GSK for $1.57 billion. Previously, bioSeedin also analyzed “Hansoh Pharma, How Many "Trump Cards" Are Left?", HS-20093 is one of the ace products held by Hansoh Pharma.

One of Hansoh's remaining three trump cards,TYK2 inhibitor HS-10374 is currently the most advanced in terms of production progress in China.，Global First TierInterestingly, on the same day that Hansoh Pharma and GSK reached their transaction cooperation, a biopharmaceutical company dedicated to designing and developing the best-in-class TYK2 inhibitorsSudo Biosciences Announces $116 Million Series B Financing, Elevating TYK2 Inhibitor to New Heights。

Tyrosine kinase 2 (TYK2) is an enzyme that regulates immune and inflammatory signaling pathways by mediating the actions of cytokines such as IL-23, IL-12, and IFNs. These cytokines are central to both innate and adaptive immune systems, including the functions of Th17 and Th1 cells as well as the activity and polarization of myeloid cells, such as macrophages and microglia.

Source: Reference [1]

CurrentlyThe world's only TYK2 inhibitor to receive FDA approval for marketing is BMS's Deucravacitinib.。And with the successful launch of Deucravacitinib, the focus on a new generation of JAK family and interleukin family autoimmune therapies is gradually heating up. Especially as Humira, the former "drug king," gradually loses its dominance, JAK inhibitors are being entrusted with the mission of becoming the next autoimmune "drug king." Among them,TYK2 Inhibitors Are the Brightest Hope in the Entire Family。

On the step of how to become the "King of Drugs," the commonality between Humira and Keytruda is thatWith a sufficiently broad range of indications。

In contrast, the breakthrough of TYK2 inhibitors in major indications,Deucravacitinib has been registered for more than 50 clinical trials.In addition to psoriasis, expansions into indications such as systemic lupus erythematosus, Crohn's disease, and ulcerative colitis are also underway. Genetic evidence further suggests that inhibiting TYK2 may benefit a broader range of autoimmune diseases, including multiple sclerosis and ankylosing spondylitis. New data also confirms the role of TYK2 in mediating underlying inflammatory processes involved in neurodegenerative diseases, such as Alzheimer's disease and amyotrophic lateral sclerosis. Such a wide range of indications likewise offers significant potential for TYK2 inhibitors.

Back to Sudo's R&D pipeline, although all four products are currently in the preclinical stage, they are targetingBrain, Skin, Peripheral Restrictive, OphthalmologyLayout of Four Different Organ Manifestations Separately.

At the same time, Sudo will use this round of financing to push its oral brain inhibitor candidate drug SUDO-550 into clinical trials next year for the treatment of multiple sclerosis, and continue to explore its potential in AD and amyotrophic lateral sclerosis (ALS).

Source: Sudo Official Website

As one of Hansoh's flagship products and the first domestically produced TYK2 inhibitor, HS-10374 has entered Phase II clinical trials. This drug is closely following BMS's Deucravacitinib, which has already been launched.Very likely to become Hansoh's next BD blockbuster。

The successful launch of Deucravacitinib in the United States not only validates the feasibility of drug targeting for this medication but also ignites a competitive race among pharmaceutical companies both in China and abroad.

Takeda's $6 billion acquisition of Nimbus NDI-034858 fired the first shot in the race. In September this year, positive results were announced from a randomized, double-blind, placebo-controlled, multi-dose Phase 2b trial, showing that once-daily oral TAK-279 treatment for psoriatic arthritis patients improved signs and symptoms of the disease by at least 20% compared to placebo at week 12. Based on the Phase 2b results, Takeda plans to initiate a Phase 3 study of TAK-279 for the treatment of psoriatic arthritis.

In China,In addition to Hansoh Pharma, BeiGene, InnoCare Pharma, and CSPCA number of pharmaceutical companies, including Hansoh Pharma, have also entered the market.

High Light Pharma TLL-018

As a globally leading highly selective dual-target TYK2/JAK1 inhibitor developed by HighLight Pharma, the company is conducting multiple clinical studies on TLL-018 for indications including rheumatoid arthritis, psoriasis, and urticaria, and has applied to initiate clinical research for indications such as atopic dermatitis and systemic lupus erythematosus.

As presented in the 23-year EULAR oral report, the ACR50 rates for the three dose groups of TLL-018 were 48.0%, 65.4%, and 72.0%, respectively.Higher than 41.7% of TofacitinibMoreover, in patients who respond poorly to tofacitinib treatment, the medium dose still shows significant efficacy. TLL-018 is expected to provide an effective treatment for refractory patients (i.e., those who do not respond to either biologics or JAK inhibitors), addressing this unmet clinical need. Meanwhile, the Phase III clinical trial was officially launched in September.

Nuo Cheng Jian Hua ICP-332, ICP-488

ICP-332 and ICP-488 are novel oral TYK2 inhibitors developed by InnoCare Pharma. Among them, ICP-332 exhibits potent inhibitory activity against TYK2 with a selectivity approximately 400 times higher for TYK2 over JAK2, potentially reducing the risk of anemia-related adverse reactions caused by JAK2 inhibition.Three days ago, InnoCare Pharma announced the results of the Phase II clinical trial of ICP-332, achieving multiple efficacy endpoints in the 80 mg and/or 120 mg dose groups., including EASI (Eczema Area and Severity Index) 50, EASI 75, EASI 90 (EASI score improved by ≥50%, 75%, 90% from baseline) and Investigator Global Assessment (IGA) 0/1 (i.e., complete or almost complete clearance of skin lesions), etc. Meanwhile, it demonstrated good tolerability and safety.

CSPC SYHX1901

SYHX1901 is a small molecule kinase inhibitor developed by CSPC Group, which has varying degrees of inhibitory activity against JAK1-3 and TYK2 kinases.In vitro and in vivo experimental results show that it has the strongest inhibitory activity against TYK2 (comparable to BMS's deucravacitinib).. Meanwhile,SYHX1901 has the potential to treat various autoimmune diseases, including but not limited to psoriasis, rheumatoid arthritis, atopic dermatitis, and systemic lupus erythematosus.. Currently in Phase II clinical trials.

BeiGene BGB-23339

BGB-23339 is a highly selective and potent TYK2 allosteric inhibitor independently developed by BeiGene. It has demonstrated highly promising activity in preclinical studies. Currently in Phase I clinical trials, the aim is to evaluate the safety, tolerability, pharmacokinetics, and preliminary activity of BGB-23339.