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THE GOOD
Approvals & Labels

Formycon nabs UK approval for Ahzantive (targeting VEGF; Eylea biosimilar, Regeneron, Bayer)
Fusion protein, diabetic macula edema, myopic choroidal neovascularisation, macular edema following retinal vein occlusion, biosimilar - Read more

Sanofi's Sarclisa (anti-CD38) lands approval in Japan + VRd regimen for newly diagnosed multiple myeloma
Monoclonal antibody, multiple myeloma, cancer - Read more

Tandem Diabetes Care's Control-IQ+ insulin-dosing algorithm receives FDA clearance for Type 2 diabetes, expanding its use beyond Type 1 diabetes.
Dosing algorithm, type 2 diabetes - Read more

THE GOOD
Business Development

Eli Lilly pays $10M to acquire Organovo's FXR program, expanding its IBD and MASH pipeline
Small molecule, metabolic dysfunction associated steatohepatitis (MASH), inflammatory bowel disease - Read more

RedHill grants Hyloris worldwide rights (excluding North America) to RHB-102 (5-HT3 receptor antagonist) for up to $60M plus royalties
Small molecule, cancer, acute gastroenteritis, gastritis, diarrhea-predominant irritable bowel syndrome (IBS-D) - Read more

PRESENTED BY TLDR BIOTECH
The Chinese Biotech Ecosystem - what do you want to know?

It's a unique time to be attending a Chinese biotech conference - the BIOSECURE Act, the current US political climate, and pharma's increasing interest in licensing China-originating assets should make for an interesting event.

From my attendance, I'll be putting together a report on the Chinese biotech space for TLDR Biotech - but this is where I need your help:

What questions do you have about this unique ecosystem? What do you want to know?

I'll try my best to answer these questions in this report - send me your questions in an email to [email protected] (if you’re received this newsletter in an email, just hit reply!).

Or even better - if you/your company is attending, let me know! Would be great to meet at the event.

⬇️ More Good News ⬇️

THE GOOD
Clinical Trials

BioCity Biopharma's SC0062 (ETA antagonist) hits Ph3 trial primary endpoint in diabetic kidney disease
Small molecule, diabetic kidney disease - Read more

Candel Therapeutics' CAN-2409 (HSV-tk gene delivery) + valacyclovir delivers survival improvement win in borderline resectable pancreatic cancer Ph2 trial
Oncolytic immunotherapy, prostate cancer, adenoviral vector - Read more

Eupraxia Pharmaceuticals' touts positive Ph1b/2a data for EP-104GI in eosinophilic esophagitis
Small molecule, eosinophilic esophagitis, microsphere-based drug delivery - Read more

Regeneron showcases Ph1/2 results for DB-OTO gene therapy in otoferlin-related profound genetic hearing loss, positive improvements across 12 children
Gene therapy, genetic hearing loss, AAV - Read more

YolTech Therapeutics touts early Ph1 clinical data for YOLT-203, a gene editing therapy targeting glycolate oxidase for primary hyperoxaluria type 1
Gene-editing, primary hyperoxaluria type 1, in vivo - Read more

Emalex Biosciences' ecopipam (dopamine blocker) reduced Tourette syndrome relapse in Ph3 trial, with approval submission planned this year
Small molecule, Tourette syndrome - Read more

THE GOOD
Company Launches

Ventuno Biotech launches to develop innovative cancer immunotherapies, co-founded by industry leaders and Octalfa company
Immunotherapy, cancer - Read more

Eleven Indian CRDMO companies form IPSO, a new industry body to advance pharmaceutical innovation and services in India
CRDMO, CDMO, CRO, trade organization - Read more

THE GOOD
Earnings & Finances

Hims & Hers expects strong 2025 growth in weight loss business, projecting $725 million revenue despite potential FDA restrictions
Compounding, telehealth - Read more [Paywall]

THE GOOD
Fundraises

Fuse Vectors $5.2M Pre-Seed raise, Copenhagen-based gene therapy company focused on innovating viral vector manufacturing
Gene therapy, AAV, viral vector manufacturing - Read more

Castle Creek Biosciences $75M royalty financing from Ligand Pharmaceuticals, focused on Ph3 study of D-Fi (FCX-007)
Gene therapy, cell therapy, dystrophic epidermolysis bullosa (DEB), royalty - Read more

Inceptor Bio $21M Series A2, develops next-generation cell therapies for cancer treatment
Cell therapy, renal cell carcinoma, cancer, CAR-T - Read more

VarmX awarded €15M ($16.4M) follow-on equity from EIC, developing DOAC bypass treatments for coagulation disorders
Recombinant protein, anticoagulant - Read more

Paradox Immunotherapeutics $10M investment from SymBiosis, advancing antibody therapies for protein misfolding diseases
Monoclonal antibody, ALECT2 amyloidosis - Read more

MAIA Biotechnology $1.43M private placement, developing targeted immunotherapies for cancer, especially THIO for NSCLC patients
Small molecule, lung cancer - Read more

Monument Therapeutics raises £850K ($1.08M) funding, using digital biomarkers for psychiatric drug development
Small molecule, cognitive impairment in schizophrenia, autism, post-operative cognitive dysfunction, post-COVID cognitive impairment, biomarker, drug development - Read more

THE GOOD
Lawsuits

Boehringer Ingelheim wins retrial in two Zantac lawsuits after Chicago jury rejects cancer claims
Small molecule, heart burn, cancer, adverse event - Read more

THE GOOD
Mergers & Acquisition

Granules India acquires Swiss CDMO Senn Chemicals for $22.3M to enter peptide therapeutics market
CDMO, peptide manufacturing - Read more

Thermo Fisher acquires Solventum's filtration unit for $4.1B to expand its bioproduct business
Filtration, bioproduction - Read more

THE GOOD
Partnerships

Takeda, BridGene Biosciences $770M partnership using IMTAC platform to discovery/design small molecules against undruggable immunology/neurology targets
Small molecule, drug design, drug discovery, platform technology, immunology, neurology - Read more

Bavarian Nordic, Biological E. Limited strategic partnership to expand chikungunya vaccine access in low-income countries
Vaccine, chikungunya virus, vaccine access, low- and middle-income countries - Read more

THE GOOD
Patient Access

Eli Lilly reduces Zepbound vial prices for those paying themselves (without insurance), ratcheting up competition against cheaper compounded alternatives
GLP-1, obesity, drug access, drug pricing - Read more

THE GOOD
Product Launches

Vevo Therapeutics partners with Arc Institute to release Tahoe-100M dataset, launching the open-source Virtual Cell Atlas with data from 300M unique cells
Single-cell analysis, transcriptome, AI - Read more

THE GOOD
Research

UC Berkeley researchers found antibodies that prevent vascular leakage caused by GP38 protein in deadly Crimean-Congo hemorrhagic fever
Antibody, Crimean-Congo hemorrhagic fever - Read more

THE GOOD
Strategic Plans

Alnylam aims to expand siRNA technology beyond liver diseases to target major ailments throughout the body by 2030
siRNA, drug delivery - Read more [Paywall]

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THE BAD
Business Development

Kiniksa Pharmaceuticals ends AstraZeneca's mavrilimumab (targeting GM-CSF receptor α) licensing agreement during strategic pipeline reprioritization
Monoclonal antibody, giant cell arteritis - Read more

THE BAD
Clinical Trial

Kiniksa Pharmaceuticals also halts Ph2b trial for abiprubart (CD40/CD154 costimulation inhibitor) in Sjögren's disease
Monoclonal antibody, Sjögren’s disease - Read more

THE BAD
IPOs

Duality Biologics' Hong Kong IPO filing expires after six months of inactivity
Antibody-drug conjugate, cancer - Read more [Paywall]

THE BAD
Layoffs

Repare Therapeutics cutting 75% of staff, down from 179 to likely under 35 employees, following previous 25% reduction last year
Small molecule, endometrial cancer, ovarian cancer - Read more

Ryvu Therapeutics cuts 30% of workforce after halting enrolment in certain Ph2 trials for RVU120 (CDK8/19 inhibitor)
Small molecule, cancer, acute myeloid leukemia, myelodysplastic syndrome - Read more

Lava Therapeutics cuts 30% of jobs and begins strategic review
Bispecific T-cell engager, acute myeloid leukemia, myelodysplastic syndrome - Read more

THE UGLY
Lawsuits

J&J sues Samsung Bioepis, alleging unlawful sublicense to third party for private label Stelara biosimilar
Monoclonal antibody, Crohn's disease, biosimilar - Read more

Compounders sue FDA for ending semaglutide shortage designation, claiming the decision was “arbitrary and reckless”
GLP-1, obesity, drug shortages, compounding - Read more

THE UGLY
Withdrawals & Recalls

FDA elevates Boston Scientific's Accolade pacemaker recall to Class I after 832 injuries and two deaths
Medical device, pacemaker - Read more

You’re all caught up on the latest Pharma & Biotech News!

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