Trials and Approvals

• Taiwan’s Allgenesis Biotherapeutics reported positive early data from a US Phase IIa trial of a bi-specific Fc-fusion protein designed to block VEGFs and integrins for Diabetic Macular Edema;
• Shanghai Antengene announced the US FDA awarded two Orphan Drug Designations for ATG-022, a Claudin 18.2 antibody drug conjugate, one for gastric cancer and another for pancreatic cancer’
• Ascentage Pharma posted a summary of four abstracts for novel cancer drug candidates that will be presented at the upcoming 2023 ASCO Annual Meeting;
• ProfoundBio, a Suzhou-Seattle ADC biotech, started a US Phase I/II trial of its CD70 ADC for solid tumors or mesothelioma, and it was approved to start a similar trial in China;
• Hangzhou Lynk Pharma dosed the first cohort of psoriatic patients in a China Phase Ib trial of LNK01004 ointment, a topical third-gen, pan-JAK inhibitor aimed at psoriasis;
• Accropeutics Bioscience of Suzhou was approved to start a Phase I trial of its oral small molecule TYK2/JAK1 inhibitor in Australia to treat inflammatory and autoimmune diseases;
• Shanghai BioRay Pharma will start China trials of BRY812, an ADC that targets human LIV-1, to treat advanced malignant tumors;
• Hangzhou Minghui Pharma dosed the first subject in a China Phase Ia trial of a novel fusion protein candidate aimed at thyroid eye disease, an autoimmune condition;
• Laekna, a Shanghai biopharma, was approved to start US Phase I/II trials of its LAE102 antibody, a novel ATP inhibitor, in patients with non-small cell lung cancer;
• Hangzhou Hanx Biopharma will start US trials of its first-in-class recombinant anti-CD47/PD-1 bispecific antibody in patients with relapsed/refractory lymphoma.
  
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Deals and Financings

• Shanghai’s LaNova Medicines sold global rights for a pre-clinical ADC candidate targeting myeloma to AstraZeneca for $600 million ($55 million upfront) plus royalties on sales;
• Xiamen Amoytop and San Francisco’s Aligos will use Aligos’ platform to discover oligonucleotides for liver diseases; Amoytop will make an upfront payment and $109 million in milestones for China rights to the drugs;
• Suzhou Coherent Biopharma closed a Series B+ round that brought its B/B+ funding to $100 million, which will underwrite clinical trials of the company’s two lead XDC candidates;
• Drug Farm, a Shanghai-Connecticut biopharma, raised $27 million from China investors, the first tranche of a C round to support trials of a hepatitis B candidate and a cardio-renal therapy;
• Chengdu’s Keymed Biosciences partnered with Shanghai Rona Therapeutics to discover first-in-class siRNA therapeutics for severe kidney diseases;

Trials and Approvals

• Jiangsu Hengrui Medicine’s PD-1 inhibitor met its Phase III trial survival endpoint for liver cancer; Hengrui’s US partner filed for US approval of the drug in a test of the FDA’s openness to China drugs;
• Shanghai CARsgen Therapeutics started enrolling patients in a US Phase II trial of CT041, a CAR-T candidate, in patients with CLDN18.2 positive gastric cancer;
• Beijing CANbridge Pharma reported positive data from its second-gen gene therapy for spinal muscular atrophy in a preclinical mouse model of SMA;
• Boan Biotech, a Shandong biologics company spun out of Luye Pharma, was approved to start China trials of a CEACAM5 (CEA)/CD3 bispecific antibody for solid tumor cancers;
• Shanghai Gracell reported its BCMA/CD19 FasTCAR CAR-T candidate will begin a China investigator-initiated trial for  systemic lupus erythematosus.

  
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Deals and Financings

• Bliss Biopharma of Hangzhou may out-license global rights (ex-China) for its HER2 ADC to Japan’s Eisai Pharma in a $2 billion deal; initially, the two companies will collaborate on Phase I/II clinical trials;
• Shanghai Junshi Bio sold regional rights (outside of China, the US and EU) for its anti-PD-1 mAb to India’s Dr. Reddy’s Labs in a deal worth up to $728 million;
• Suzhou Zion Pharma out-licensed ex-China global rights for its HER2 inhibitor designed to cross the blood-brain barrier to Roche in a $680 million agreement ($70 million upfront);
• Hangzhou Chance Pharma entered a deal worth up to $144 million to commercialize Acorda’s inhaled therapy for Parkinson’s disease in Greater China;
• Guangzhou Reforgene Biotechnology closed a $15 million Pre-B financing for its portfolio of gene editing candidates, including a clinical stage therapy for thalassemia;

Trials and Approvals

• Shanghai LianBio will launch Camzyos® (mavacamten), its therapy for obstructive hypertrophic cardiomyopathy, in Macau following a successful Phase III China trial;
• Suzhou Innovent Biologics reported that a high dose (9 mg) of mazdutide produced a mean weight loss of 15.4% in obese China patients after a 24-week Phase II trial;
• Suzhou GenAssist Therapeutic said the US FDA accepted an IND for its novel in vivo gene editing candidate as a treatment for Duchenne muscular dystrophy;

Company News

• EQRx, a Cambridge, MA company will stop its efforts to market China drugs for western markets, at a 50% discount from the competition.

  
  
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Deals and Financings

• Pfizer signed up Shanghai’s Sinopharm to market as many as 12 innovative Pfizer drugs in China over the next three years; financial details or descriptions of the drugs were not released;
• VintaBio, a cell and gene therapy CDMO, opened the doors of its 22,500 square foot Philadelphia facility after raising $64 million in a funding led by Shanghai Decheng Capital;

AI News

• XtalPi, a Shenzhen AI drug development company, partnered with Germany’s Merck, combining computational analysis with wet lab experiments to engineer crystal morphology;

Trials and Approvals

• Shanghai Genor Biopharma reported its NDA for a cyclin-dependent kinase 4/6 inhibitor, which was tested for HR+ breast cancer, was accepted for review by China’s NMPA;
• Shanghai Junshi Biosciences said its PARP inhibitor met its primary efficacy endpoint as a maintenance therapy in a Phase III trial for ovarian, fallopian tube or peritoneal cancer;
• Bridge Biotherapeutics dosed the first patient in a global Phase IIa trial of its autotaxin inhibitor to evaluate the efficacy, safety and tolerability of the candidate in patients with idiopathic pulmonary;
• Shanghai JW Therapeutics will start a China Phase I/II trial of its CAR-T cell therapy in patients with moderate to severe systemic lupus erythematosus;
• Suzhou’s Sirnaomics announced plans to start a US Phase I trial of its novel RNAi Factor XI anticoagulant that impacts the intrinsic coagulation pathway without affecting bleeding time;
• China Grand Pharma of Hong Kong was approved to start a China Phase I trial of a molecularly-targeted radiation therapy for glioblastoma developed by Telix Pharma of Australia;
• OnCusp Therapeutics, a New York City-Shenzhen biopharma, will release pre-clinical data on its lead candidate, a high affinity anti-CDH6 antibody drug-conjugate with an exatecan payload.
  
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Deals and Financings

• Duality Biologics (Suzhou) out-licensed global rights (ex-China) for two ADC candidates to BioNTech in a deal worth $170 million upfront and up to $1.5 billion in milestone payments;
• Pierre Fabre, a French pharma, announced a $618 million agreement to acquire EU/China rights for two highly selective mutant EGFR inhibitors from Boston’s Scorpion Therapeutics;

Trials and Approvals

• Shanghai Mabwell was approved to launch a denosumab biosimilar in China for osteoporosis in postmenopausal women at high risk of fracture;
• Shanghai HutchMed completed the rolling submission of a US NDA for its lead drug, fruzuintinib, an oral VEGFR-1, -2 and -3 inhibitor, for patients with metastatic colorectal cancer;
• Shanghai Nuance Pharma has dosed the first patient in a China Phase III trial of a first-in-class, inhaled, dual inhibitor therapy for COPD that offers both bronchodilator and anti-inflammatory effects;
• Shanghai Mabwell reported its Nectin-4 targeted site-specific ADC candidate posted promising clinical results in a China Phase II trial for solid tumor cancers;
• Biosion USA was given a green light to begin a US Phase II trial of its lead asset, BSI-045B, an anti-TSLP mAb, for atopic dermatitis, asthma and other immune-related diseases;
• Suzhou Evopoint Biosciences will start a China Phase Ib/II trial of its EZH2 inhibitor in combination with Merck/MSD’s anti-PD-1 drug in patients with advanced solid tumors;
• Lynk Pharma of Hangzhou said a China Phase I trial of its third-gen, intestinal-restricted JAK inhibitor showed the candidate was safe and well-tolerated with good pharmacokinetics;
• Beijing InnoCare Pharma has dosed the first subject in a China Phase I trial of its novel targeted protein degrader, a CRBM modulator, to treat multiple myeloma and non-Hodgkin's lymphoma.
  
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