BioSignal
@BioSignal
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Concise biotech intelligence. Oncology, cell therapy, antibodies, ADCs, gene therapy, and early clinical signals. High signal, low noise.
Joined November 2025
The "Holy Grail" of Cell Therapy just moved forward—and it's not from $ALLO or $CRBU. MaoXing Biologics just secured FDA approval to launch Phase 2 for MT027, a Universal (Off-the-shelf) CAR-T targeting Glioblastoma. The Alpha is in the manufacturing: MaoXing has ditched standard
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BREAKING: The FDA just cleared MaoXing Biologics to enter Phase 2 with MT027, officially making it the world's most advanced B7-H3 CAR-T. This is a massive development for the "Graveyard Target." After high-profile failures from MacroGenics ($MGNX) and Y-mAbs ($YMAB), the
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Western SynBio ($DNA, $AMRS) collapsed because the unit economics never worked. China just fixed the margin problem by switching the feedstock. The Visual: Imagine a cost curve. Left Side (Standard Corn-based PLA): High Cost ($2,500/ton), competes with food supply. Right Side
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The "GLP-1 Muscle Loss" trade just got a massive new player from China. 🧵 While Wall Street obsesses over Scholar Rock ($SRRK), a new ActRII asset just moved forward in the CDE filings: JMT206. The Insight: JMT206 is a fully human anti-ActRIIA/IIB antibody. • Mechanism:
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The era of "Probabilistic Diagnosis" in Alzheimer’s is over. For decades, we diagnosed dementia by ruling everything else out. Now, we are ruling it in with $90\%+$ accuracy using a single vial of blood. The "Alpha" in 2025 isn't just the drugs—it's the Diagnostic
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Headline: China is leapfrogging the "Mechanical Cleaning" era of dentistry. While Western periodontics still relies on scaling and root planing (SRP) or lasers ($ALGN), Chengdu-based Shilian Kangjian just launched the world’s first clinical trial for a "Ready-to-Use" Dental
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JUST IN: Shanghai Suncadia Biopharma just secured CDE IND approval for NP001, a First-in-Class autologous polyclonal Treg cell therapy for Multiple System Atrophy (MSA). This is a major regulatory pivot. While Western Treg leaders like Coya Therapeutics ($COYA) and Quince
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The consensus is that China only does "Fast-Follower" drugs. The 2026 JPM FIC Summit data just proved that narrative is dead. In 2025 alone, Chinese out-licensing topped $100B—doubling in a single year. The "Alpha" isn't in me-too drugs anymore; it's in toxicity engineering and
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BREAKING: The largest HK Biotech IPO of 2025 has officially launched. Insilico Medicine ("The AI Drug Pioneer") is going public. Ticker: 03696.HKValuation:Â HK13.4B ($1.7B USD) Listing Date: Dec 30 The "Smart Money" Signal: Ignore the valuation; look at the Cornerstone
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URGENT: AstraZeneca is pulling its anticoagulant reversal drug Andexxa from the US market immediately (by Dec 22). The FDA Accelerated Approval pathway just claimed another victim. The Catalyst: The confirmatory study (ANNEXA-I) failed disastrously. • Thrombosis rates doubled:
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BREAKING: Major leadership overhaul at China's pharma giant CSPC Pharmaceutical ($1093.HK). The "Succession Risk" is officially off the table. Chairman Cai Dongchen has appointed his son, Dr. Cai Lei (45), as the new CEO. Old CEO Zhang Cuilong steps down to Executive Director.
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The roadmap for China’s 2026 R&D strategy is being drawn next month. China’s heavyweights—Hengrui Medicine and HEC Pharm—are convening in Shanghai to address the sector's biggest existential threat: "Target Homogeneity." The "Alpha" Signal: The era of "Me-Too" drugs (100
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Stop obsessing over China's brutal NRDL price cuts. A new policy just handed the biotech sector a massive "Commercial Fast Lane." It's called the "Three Exclusions" (San Chuwai), and it creates a protected ecosystem for the 19 drugs in the new Commercial Insurance Innovation
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CONTRARIAN TAKE: The "Sledgehammer" era of Immuno-Oncology might be wrong. A groundbreaking Nature paper (Nov 2025) just exposed a critical flaw in how we dose PD-1 inhibitors like Keytruda ($MRK) and Opdivo ($BMY). The Paradox: We thought blocking PD-1 released the "brakes" on
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BREAKING: The BIOSECURE Act has officially passed Congress attached to the 2026 NDAA. It now heads to the President’s desk for signature. The "loophole" update: The final text removed specific company names (like WuXi AppTec). However, it now bans contracts with firms on the
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J&J just declared war on AstraZeneca’s lung cancer dominance. The FDA has approved the Subcutaneous (Sub-Q) version of Rybrevant for EGFR+ NSCLC. This is a massive convenience upgrade: • IV Infusion: Hours in a chair. • Sub-Q (New): 5 minutes. The Clinical Edge: When combined
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The biggest bottleneck in Cell Therapy isn't efficacy—it's the "Viral Tax." Current CAR-T manufacturing relies on Lentiviral vectors. They are expensive, hard to scale, and create massive supply chain logjams. German biotech T-CURX just closed a $20M Series A to bypass this
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The "Post-Carvykti" era of Cell Therapy is emerging, and it’s dual-targeted. While Legend Biotech ($LEGN) dominates Multiple Myeloma with BCMA, the biggest failure mode is "Antigen Escape"—the tumor simply stops expressing BCMA to survive. O&D Bio (Private) just released Phase 1
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BREAKING: Cytokinetics ($CYTK) just achieved a rare regulatory feat—China approved its blockbuster heart drug before the US FDA. The NMPA just greenlit Aficamten for oHCM, officially launching the "Second Generation" Cardiac Myosin Inhibitor era. This creates an immediate
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The $4 Billion gamble just paid off. In 2022, Takeda ($TAK) dropped $4B cash to buy a single Phase 2 asset from Nimbus, betting they could build a "Best-in-Class" TYK2 inhibitor. Today, the Phase 3 data confirmed it. The Data: • Zasocitinib beat $AMGN's Otezla on all primary
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