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Deals and Financings

• Shionogi, an Osaka innovative pharma, signed an option with France’s Cilcare to in-license two drug candidates aimed at hearing loss in a deal worth up to $445 million;
• XtalPi, a Shenzhen-Boston AI drug discovery company, raised $127 million in a Hong Kong IPO, the third-largest Hong Kong IPO of the year;
• Takeda entered a $100 million option agreement to acquire global rights (ex-China) to Suzhou Ascentage’s lead drug, a third-gen BCR-ABL tyrosine kinase inhibitor;
• Australia’s EnGeneIC, a company developing a targeted nanocell technology for cancer therapies, announced financial partnerships with two Singapore entities;

Company News

• Tokyo’s Kyowa Kirin will invest up to $530 million to build a biologics manufacturing plant in North Carolina’s Research Triangle;
• Asia Scientific Global, a company developing inhaled forms of existing drugs, has built a laboratory in Taiwan, and will build a second facility in Singapore later this year;

Trials and Approvals

• Vancouver’s Zymeworks said its BLA for a HER2-targeted bispecific antibody was accepted for review in China for HER2-positive biliary tract cancer;
• Shanghai Junshi Bio said toripalimab, its anti-PD-1 mAb, met the progression free survival endpoint as a first-line treatment for advanced hepatocellular carcinoma;
• Suzhou Ascentage Pharma was approved to start a China Phase III trial of olverembatinib for succinate dehydrogenase (SDH)-deficient gastrointestinal stromal tumor;
• Nanjing Biosion presented positive data from a Phase II proof-of-concept trial of Bosakitug, a high potency anti-TSLP mAb, for atopic dermatitis.

Deals and Financings

• Structure Therapeutics, a San Francisco-Shanghai AI company, announced positive clinical results for its obesity drug and then raised $476 million in a new offering;
• Suzhou Alphamab Oncology signed a $615 million deal with ArriVent BioPharma, using its platforms to discover antibody drug conjugates for ArriVent;
• Summit Therapeutics of Miami expanded its rights to distribute Akeso’s ivonescimab in a $70 million agreement, adding Central/South America, the Middle East and Africa;

Company News:

• GenScript Biotechnology may be the next target of the US Congress as part of its ongoing examination into biopharmas with links to China, although it was founded in New Jersey and then expanded into China;

Trials and Approvals

• Suzhou Ascentage Pharma reported an objective response rate of 90.9% in a global Phase Ib/II trial of its Bcl-2 inhibitor in Waldenström macroglobulinemia patients;
• Nanjing Leads Biolabs presented clinical data from a Phase I/II trial of LBL-024, a bispecific antibody that showed efficacy in patients with neuroendocrine carcinoma;
• Yantai RemeGen reported positive data from a first-in-human China Phase I/II trial of an ADC that targets mesothelin and delivers a monomethyl auristatin E (MMAE) payload;
• Singapore’s SCG Cell Therapy Pte announced positive data from an autologous hepatitis B virus-specific T-cell receptor-engineered T Cell therapy;
• AbelZeta Pharma, a Maryland-Shanghai CAR-T company, reported encouraging results from a China Trial of C-CAR031 in patients with advanced hepatocellular carcinoma;
• I-Mab announced plans to form a clinical trial collaboration with Bristol Myers Squibb combining I-Mab’s Claudin 18.2 x 4-1BB bispecific antibody, with BMS’s PD-1.

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Deals and Financings

• Suzhou MediLink partnered its ADC platform to discover candidates for several novel targets chosen by BioNTech in a deal worth up to $1.8 billion in milestones;
• Asahi Kasei, a Japanese conglomerate, made a $1.1 billion offer to buy Calliditas Therapeutics of Sweden, a rare disease company with one FDA approved drug;
• Bio-Thera Solutions of Guangzhou sold European rights for a biosimilar to Germany’s STADA Arzneimittel in a $157.5 million agreement;
• Suzhou CStone is selling Eastern European marketing rights for its anti-PD-L1 lead drug, to Switzerland’s Ewopharma in a deal worth $51 million upfront plus milestones;
• Guangzhou Burning Rock will collaborate with Germany’s Bayer to develop companion diagnostic assays to improve treatment choices for China cancer patients;
• Shanghai HuidaGene, a CRISPR company, partnered its high-fidelity Cas12 CRISPR nuclease (hfCas12Max) with Synthego of Redwood City, CA;

Trials and Approvals

• Guangzhou’s Akeso reported that its PD-1/VEGF bispecific antibody posted better progression-free survival results than Merck’s Keytruda in NSCLC patients;
• San Diego’s Gyre Therapeutics was approved to begin China trials of F230, a selective endothelin receptor antagonist, in patients with pulmonary arterial hypertension.
  
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Deals and Financings

• Japan’s Takeda acquired global rights to an Alzheimer’s therapy developed by AC Immune SA of Switzerland for $100 million upfront and up to $2.1 billion in milestones;
• San Diego’s Erasca in-licensed two China-developed pre-clinical RAS candidates in two separate agreements with a total value of $359 million;
• Shenzhen Beimei Pharma acquired greater China rights for Twyneo®, a therapy for acne vulgaris, from Israel’s Sol-Gel for $15 million;

Trials and Approvals

• Shanghai’s Zai Lab reported China’s NMPA approved repotrectinib for adult patients with locally advanced or metastatic ROS1-positive non-small-cell lung cancer;
• Shanghai Everest Medicines launched Nefecon®, a treatment for IgA nephropathy in China, a glomerular disease that can cause end-stage renal disease;
• Suzhou Ractigen Therapeutics announced approval of its China IND for RAG-17 as a therapy for Amyotrophic Lateral Sclerosis;
• Beijing InnoCare Pharma completed enrollment in a China Phase II trial of ICP-488, a TYK2 (tyrosine kinase 2) JH2 allosteric inhibitor for psoriasis therapy;
• Shanghai Mabwell reported positive data from a China trial of its novel Nectin-4-targeting ADC for triple-negative breast cancer;
• Nanjing IASO Bio announced a single-cell analysis was published in a scientific journal for its anti-BCMA CAR T cell therapy that targets neuromyelitis optica spectrum disorder.
  
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Deals and Financings

• Hangzhou Sciwind out-licensed Korean rights for its GLP-1 analog aimed at type 2 diabetes and obesity to HK inno.N in a deal that includes $56 million in potential milestones;
• Beijing’s Sino Biological, a reagents/contract research services company, completed its $48 million acquisition of Vancouver’s SignalChem Biotech, an enzyme company;
• Beijing’s Biocytogen signed a TCR-mimic antibody evaluation and potential licensing agreement with BioCopy AG of Basel, Switzerland;

Government and Regulatory

• BIO, the US-based biopharma trade association, reported that 74% of respondents to a survey have business with China CDMOs (mostly WuXi AppTec) and would need up to eight years to find new CDMO partners;

Company News

• Shanghai Ribobay Pharma has built a cGMP-level oligonucleotide manufacturing center using Cytiva's first FlexFactory platform for oligo manufacturing;

Trials and Approvals

• Innovent Biologics reported positive Phase III results for mazdutide, its GLP-1/GCGR dual therapy for type 2 diabetes and weight loss that outperformed single therapies;
• Seoul’s HanAll Biopharma has started a US Phase III trial to evaluate the efficacy of tanfanercept, a novel topical anti-inflammatory therapy for dry eye disease;
• Nanjing Leads Biolabs has been approved to begin a China Phase III trial of an anti-PD-L1/4-1BB bispecific antibody developed by Leads aimed at solid tumor cancers;
• Shanghai NeuShen Therapeutics has dosed the first healthy patient in an Australian Phase I trial of its novel selective M4 receptor positive allosteric modulator for schizophrenia;
• Guangzhou Bio-gene Technologies started a China Phase I trial for an autologous CAR-T cell therapy that targets CLL-1 for relapsed/refractory acute myeloid leukemia;
• Suzhou’s Eluminex Biosciences was approved to start US trials of its novel trispecific fusion antibody aimed at treating diabetic macular edema;
• Chengdu WestGene Biopharma will begin US trials of its Epstein-Barr (EB) virus-related mRNA therapeutic cancer vaccine, the first mRNA clinical stage candidate for cancer.
  
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