Capsule Intelligence Station | Behind Five Approval Signals: Why These New Drugs Chose the Capsule Dosage Form
🔈 Since June, NMPA and FDA have granted concentrated approvals to multiple oral solid dosage forms targeting oncology, gastroenterology, and psychiatry. A clear trend has emerged: almost all of these core strategic products have uniformly chosen the capsule dosage form. With increasing API potency, narrowing stability windows, and rising patient compliance demands, capsules are becoming the "justified first choice" for high-value innovative drugs.
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[Express Approvals for Pharmaceutical Companies]
01 | Anruitinib Capsules (VC004) Conditionally Approved
On June 4, 2026, the Class 1 innovative drug Anruitinib Capsules from Jiangsu Vcare Pharma was conditionally approved by NMPA for NTRK-positive tumor-agnostic solid tumors. This next-generation TRK inhibitor contains an active core highly sensitive to moisture and oxidation, and has an extremely bitter taste. The capsule shell provides efficient physical isolation, completely masking the bitterness. Compared with tablets, capsules avoid the risk of API polymorph transformation induced by high mechanical stress and frictional heat.
⚠️ When initiating confirmatory clinical trials, long-term stability data of the API is a key review point; dosage form selection needs to be locked in at the project initiation stage.
02 | Benzoic Acid Andasertinib Capsules (Anbirui®) Completes Review
On April 30, 2026, Anshi Pharma’s Class 1 innovative drug was approved by NMPA for EGFR exon 20 insertion mutation non-small cell lung cancer. The drug simultaneously received Priority Review, Breakthrough Therapy designation, and Conditional Approval. EGFR-TKI drugs are highly susceptible to degradation by light, moisture, and heat; capsules offer significantly better sealing than uncoated tablets, reducing environmental moisture exchange and better matching the swallowing experience of long-term medication patients.
⚠️ Brain metastasis patients on multi-drug combinations have high requirements for in vivo exposure reproducibility. In accelerated testing, focus should be on disintegration delay and dissolution profile drift caused by capsule shell compatibility.
03 | Larotrectinib Capsule Generic Approved by FDA
On June 11, 2026, Alembic Pharmaceuticals received tentative approval from the FDA for the first generic of Larotrectinib capsules, equivalent to Bayer’s original Vitrakvi, securing 180 days of exclusivity. The original chose capsules to perfectly solve the pain points of extremely bitter API and moisture sensitivity. Generic approval means BE consistency needs to be strictly benchmarked against the original; inter-batch stability of capsule material directly determines the success or failure of dissolution comparison.
⚠️ In BE trials of capsule generics, change management of capsule shell suppliers is the core of review; it is recommended to lock in control strategy during formulation screening.
04 | Utidelone Shifts from Injection to Oral Capsule
On June 11, 2026, Bio-Thera Solutions’ core product Utidelone capsules (UTD2) for advanced breast cancer Phase III clinical trial was approved. The core challenge in converting from injection to oral dosage form is gastrointestinal stability and bioavailability. Capsules can flexibly carry pellets, granules, or self-emulsifying systems, and can be directly customized for enteric coating; the filling process is also safer for crystal form stability.
⚠️ Before clinical initiation, focus on evaluating capsule disintegration performance in different pH media, and precisely bridge with injection plasma exposure characteristics.
05 | Capivasertib Capsules Combo Therapy Scores Again
On June 12, 2026, AstraZeneca’s Capivasertib (Truqap) capsules were approved by FDA for PTEN-deficient prostate cancer. An intermittent dosing regimen (4 days on, 3 days off) is recommended. Intermittent regimens impose strong constraints on dose accuracy and patient compliance. Oral capsules require no preparation, are unaffected by food, and can significantly improve medication adherence outside hospitals.
⚠️ When multi-target or high-barrier innovative drugs adopt complex dosing regimens, high dose accuracy and stable release are the primary indicators for dosage form adaptation.
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[Global Data Quick View]
• Scale: In 2026, the global empty capsule market size is approximately 6.58 billion by 2034 (CAGR 6.74%).
• Preference: Overseas surveys show that over 54% of patients prefer capsules among oral formulations; the proportion of capsules in highly active new drugs for tumors and chronic diseases is increasing year by year.
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[UnicornShell: Professional HPMC Plant Empty Capsule Selection Support]
Shanghai UnicornShell Pharmaceutical Technology Co., Ltd. focuses on R&D and supply of high-quality HPMC plant empty capsules. We deeply participate in your R&D lifecycle, breaking the single supply model:
Certification system: NMPA ｜ FDA ｜ Halal ｜ Kosher ｜ GMP ｜ BRCGS ｜ ISO9001
✔ Selection adaptation channel: If you are initiating a project, evaluating dosage forms, or preparing change documentation this quarter, please send "API/extract brief description + dosage form requirements (enteric/controlled release) + estimated batch size" to our email. Our technical team will customize an exclusive Dosage Form Adaptation Assessment Brief for you within 48 hours — efficient and objective.
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