Recent Articles in Week in Review

Deals and Financings

• Jiangsu Hengrui Pharma out-licensed US rights for a small molecule EZH2 inhibitor aimed at lymphoma in a $706 million agreement with Treeline Biosciences of Connecticut;
• CSPC Pharma sold ex-China rights for a Nectin-4 antibody drug conjugate to Boston’s Corbus Pharma in a backloaded $692.5 million deal;
• Harbour BioMed out-licensed US rights for a bispecific immune activator to Cullinan Oncology of Alabama in a $588 million deal;
• Wondercel Therapeutics, a Shenzhen next-gen immune cell therapy company led by former CSO of Legend Biotech, Xiaohu Fan, raised $14 million in an angel round;

Trials and Approvals

• Clover Biopharma launched its COVID-19 vaccine, a recombinant SARS-CoV-2 subunit vaccine, in China as a second booster dose for at risk individuals;
• Shanghai Henlius Biotech reported the US FDA accepted its BLA for trastuzumab, a biosimilar to Roche’s Herceptin;
• Shanghai Junshi Bio and Coherus of Redwood City, CA reported their partnered PD-1 posted positive results in a US Phase III nasopharyngeal carcinoma trial;
• Suzhou Innovent Bio dosed the first patient in a China Phase III trial of picankibart, a novel mAb, as an extended-dose therapy for psoriasis;
• Frontera Therapeutics, a US-China gene therapy company, began China trials of its three leading candidates – each of them dosing the first patient in the first two months of 2023;
• Boan Biotech, a Luye Pharma subsidiary, dosed the first patient in a China Phase I trial of its anti-CD25 antibody in patients with solid tumor cancers.

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Deals and Financings

• Beijing CANbridge Pharma acquired global rights to a novel second-gen gene therapy for spinal muscular atrophy developed by UMass Chan Medical School;
• Shanghai Zhimeng Biopharma signed an agreement to out-license global rights for its TLR8 agonist to GlaxoSmithKline as an HBV treatment;
• Shanghai JiXing Pharma bought global rights to a preclinical hypertension asset from PhaseBio Pharma, a bankrupt Philadelphia company;
• GenScript ProBio, a Nanjing biologics CDMO, partnered with London’s Bio Immunitas to develop novel therapies using BI’s human Recombinant Protein Platform;
• Shanghai Asieris Pharma formed a research collaboration with San Francisco’s ReviR Therapeutics to develop novel therapies for genitourinary tumors;

Government and Regulatory

• China is planning to prohibit any export from biotech companies engaged in certain cutting-edge sectors -- cell cloning and gene editing technology for human use along with restrictions on the export of CRISPR gene editing technology and synthetic biology;

Trials and Approvals

• Kintor, a Suzhou biopharma, reported positive top-line data from a US Phase I trial of a degrading androgen receptor candidate for androgenetic alopecia and acne;
• Beijing InnoCare reported the American Journal of Hematology published positive results from a Phase II trial of its BTK inhibitor orelabrutinib for lymphoma;
• Shenzhen ImmVira reported its first intratumoral injected oncolytic virus product was effective in early tests, raising PFS in melanoma patients to 12.9 months;
• Jiaxing Technoderma Medicines has begun a US Phase I trial of a JAK1/Tyk2 small molecule inhibitor topical ointment for Atopic Dermatitis.

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Deals and Financings

• Structure Therapeutics, a Shanghai-San Francisco company, completed a $161 million NASDAQ IPO to apply AI/structure technology to develop oral small molecule candidates for chronic metabolic and pulmonary diseases;
• CS Pharmaceuticals of London entered a $336 million agreement with South Korea’s Daewoong for China rights to an Idiopathic Pulmonary Fibrosis therapy;
• NeuShen Therapeutics, a Shanghai-Boston CNS biotech, formed a three-year Research Agreement with UMass Chan Medical School to develop a gene therapy for ALS;
• Shanghai CARsgen formed a collaboration to test a combination of its Claudin18.2 mAb and Roche’s PD-L1 checkpoint inhibitor in gastric cancer patients;
• Hangzhou AnHeart will use two assays developed by Palo Alto’s Guardant Health as companion diagnostics to its ROS1 inhibitor;

Trials and Approvals

• Wuhan’s Nervtex announced China approval of its AI system that analyzes motor symptoms for clinical decision support of Parkinson's disease patients;
• Beijing Help Therapeutics was approved to start China clinical trials of a universal allogeneic iPS cell-derived cardiomyocyte therapy for ischemic heart failure;
• Gracell Biotech, a Shanghai cell therapy company, was approved to start a US Phase Ib/II trial of its lead candidate in relapsed/refractory multiple myeloma;
• HuidaGene Therapeutics of Shanghai and New Jersey was cleared to start a US Phase I trial of a CRISPR-based medicine for patients with inherited retinal dystrophies.

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Deals and Financings

• Shanghai’s HutchMed out-licensed global rights (ex-China) for a colorectal cancer therapy to Japan’s Takeda (TSE: 4502) in a deal worth up to $1.1 billion ($400 million upfront);
• HBM Alpha Therapeutics, a novel endocrine disease biotech incubated by Harbour BioMed of the US and China, completed a seed financing of undisclosed size;

Trials and Approvals

• Guangzhou Akeso was approved for a China launch of penpulimab, an anti PD-1 mAb, as a first-line treatment for squamous non-small cell lung cancer;
• Legend Biotech, a New Jersey-Nanjing biotech, announced its CAR-T therapy improved Progression Free Survival compared to standard therapies in multiple myeloma patients;
• Shanghai Junshi Biosciences’ NDA for a COVID-19 treatment has been accepted for review by China’s NMPA;
• Hangzhou Ascletis reported China approved its IND for ASC10, an oral treatment for monkeypox that is also being tested in SARS-CoV-2 patients.

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Deals and Financings

• Shanghai Mabwell Biosciences out-licensed global rights (ex-China) for a rare disease drug to Disc Medicine of Cambridge, MA in a $412.5 million agreement;
• Aprinoia Therapeutics, a company developing products for neurodegenerative diseases, agreed to merge with a SPAC at an implied value of $280 million;
• GenScript ProBio of Nanjing, a biologics CDMO that is majority owned by gene synthesis company GenScript Biotech, raised $224 million in a C round;
• Shanghai CARsgen out-licensed China commercialization rights for its lead asset, a BCMA CAR T, to Huadong Medicine for $181 million;
• Structure Therapeutics, a South San Francisco-Shanghai company developing GPRC drugs based on structural design, filed for a $100 million IPO on NASDAQ;
• Nanjing IASO Bio completed a $75 million Series C1 funding to support its novel autologous and allogeneic CAR-T and biologic products;
• Shanghai Ronovo Surgical has raised $50 million including its latest round to conduct a clinical trial for its first robotic laparoscopic surgery device, Carina™;
• Tigermed, a full-service Hangzhou CRO, acquired Marti Farm, a European CRO based in Zagreb, Croatia;

Trials and Approvals

• Shanghai Henlius Biotech has been approved to launch its anti-PD-1 mAb in China as a first-line treatment for extensive stage small cell lung cancer.

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