Deals and Financings
Adlai Nortye (ANL), a Hangzhou-New Jersey immunoncology biopharma, completed a $97.5 cardinal IPO connected the NASDAQ exchange, consisting of $57.5 cardinal from the nationalist offering and $40 cardinal successful a concurrent backstage placement (see story). Founded successful 2016, Adlai Nortye has 3 candidates successful objective trials and 3 pre-clinical signifier assets. The company’s pb drug, buparlisib, is an oral pan-PI3K inhibitor presently successful a planetary Phase III objective proceedings for caput and cervix squamous compartment carcinoma. Adlai Nortye’s shares were priced astatine $23 per ADS successful the offering, but they are trading astatine $16.90, a nonaccomplishment of 27%.
Nanjing Triastek closed a $20 cardinal Pre-C financing circular to enactment improvement of its 3D printing process for analyzable cause transportation and programmed merchandise medications. The company’s proprietary technology, the Melt Extrusion Deposition (MED®) 3D printing process, combined with integer formulation improvement techniques, have been enactment to usage to make timed merchandise drugs. Triastek is besides processing caller exertion including Semi-Solid Extrusion, Micro-Injection Molding, and Micro-Droplet Jetting to present and make oral peptides, gastric retention and precocious potency products. The circular was led by Guoxin Investment.
Hangzhou Qihan Biotech closed a $16 cardinal pre-B backing to enactment the company’s gene-edited stem compartment products, including a pb merchandise that has started China trials for CD19-positive B-cell non-Hodgkin lymphoma. Qihan says QN-019a is the archetypal IND approved successful China for a gene-edited Induced Pluripotent Stem Cells-derived compartment therapy. The institution uses multiplexable genome editing exertion to modify iPSCs and differentiate them into a earthy slayer compartment therapy product. The pre-B circular was led by Zhejiang Industrial Fund. In 2021, Qihan raised $67 cardinal successful an A+ round.
Shanghai’s I-Mab (IMAB) announced AbbVie (ABBV) volition extremity its CD47 concern with I-Mab, returning each rights for the cause (see story). In 2020, AbbVie acquired ex-China rights to the cause successful a woody worthy up to $2 billion, including options connected 2 different I-Mab candidates. I-Mab volition support $200 cardinal successful AbbVie upfront and milestone payments. AbbVie said the breakup was a “strategic decision,” a statement that wasn’t explained, though the institution has ended respective partnerships recently. One twelvemonth ago, AbbVie reduced the scope of the I-Med partnership, stopping 2 Phase Ib trials of lemzoparlimab.
Trials and Approvals
Yantai RemeGen (OTCPK:REGMF, HK: 9995, SHA: 688331) reported affirmative results from a Phase III proceedings of Telitacicept, the company’s autoimmune drug, arsenic a therapy for rheumatoid arthritis (see story). Telitacicept targets 2 cell-signaling molecules captious for B-lymphocyte development: B-cell lymphocyte stimulator and a proliferation inducing ligand (APRIL). The operation has been shown to trim B-cell mediated autoimmune responses implicated successful respective autoimmune diseases. RemeGen has filed a Telitacicept NDA successful China for the RA indication. In 2021, Telitacicept was approved successful China to dainty systemic lupus erythematosus.
Shanghai AffaMed volition statesman China Phase III trials of Risuteganib (luminate®), its first-in-class injectable ophthalmic intravitreal campaigner for intermediate adust age-related macular degeneration (Dry AMD). Luminate® is simply a first-in-class integrin regulator that regulates aggregate pathways of oxidative accent response, including mitochondrial dysfunction, which contributes to intermediate Dry AMD. In 2021, AffaMed acquired greater China rights (including manufacturing) to the campaigner from South Korea’s Hanmi Pharma successful a $145 cardinal agreement. AffaMed believes AM011 volition beryllium the archetypal merchandise successful China to commencement Phase III improvement for Dry AMD.
BioCity Biopharma, headquartered successful Wuxi, China, volition behaviour a China Phase Ib/II proceedings of its BC3402, a mAb targeting the T compartment immunoglobulin and mucin domain-containing macromolecule 3 (TIM-3), unneurotic with AstraZeneca's (AZN) approved anti-PD-L1, Imfinzi (durvalumab) (see story). The proceedings volition enroll patients with precocious hepatocellular carcinoma (HCC). BioCity believes BC3402 has the imaginable to beryllium a best-in-class anti-TIM-3 mAb due to the fact that it binds to aggregate TIM-3 epitopes with a higher binding affinity than akin candidates. BioCity develops differentiated therapeutics for crab and autoimmune disorders including chronic kidney diseases.
Suzhou Gracell Biotech (GRCL) posted beardown results from an ongoing Phase I investigator-initiated proceedings of the company’s dual targeting CAR-T compartment therapy for aggregate myeloma (see story). GC012F produced a 100% wide effect complaint (ORR) and a 100% minimal residual illness (MRD) complaint arsenic a first-line therapy successful 19 transplant-eligible patients. The enrollees were high-risk, recently diagnosed aggregate myeloma (NDMM) patients. GC012F, Gracell’s pb drug, is simply a dual CD19 and B-cell maturation antigen (BCMA) campaigner that besides benefits from the company’s autologous FasTCAR technology, which requires lone 24 hours of manufacturing time.
Hangzhou Ascletis Pharma (OTCPK:ASCLF, HK: 1672) has enrolled the archetypal 120 patients successful the China Phase III proceedings of ASC40 combined with bevacizumab to dainty recurrent glioblastoma (see story). ASC40 is an oral, selective tiny molecule inhibitor of fatty acerb synthase, an enzyme that regulates de novo lipogenesis. ASC40 is expected to alteration vigor proviso and disturb the membrane phospholipid creation of tumor cells. In 2019, Ascletis acquired China rights to ASC40 from San Francisco's 3-V Biosciences for NASH. In a Phase II trial, the operation produced an wide effect complaint of 65% with a 20% implicit effect complaint successful patients with rGBM.
Elpiscience, a Shanghai-Suzhou oncology immunotherapy company, has dosed the archetypal diligent successful an Australian Phase 1 proceedings of ES009, an anti-LILRB2 monoclonal antibody. LILRB2 is an inhibitory receptor expressed connected the aboveground of myeloid cells that contributes to immune suppression successful the tumor microenvironment. ES009 binds to an epitope connected quality LILRB2, blocking LILRB2 binding to aggregate ligands. This reprograms myeloid cells from an anti-inflammatory phenotype into a pro-inflammatory phenotype, allowing T cells to function. The proceedings is enrolling patients with precocious coagulated tumor cancers.
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