DEEP RESEARCH · BIOTECH / MEDTECH

Korea Biotech & Medical Devices — December 2025 Roundup (Mirae Asset)

BBB shuttles, ADC linkers, the Biosecure Act, Zymfentra’s PBM grind, and aesthetic direct-distribution — a single read on the 2026 healthcare board.

Published: 2025-12-05 · Source: Mirae Asset Securities December research + corporate IR materials · Original Naver Blog post

0. Bottom line first

1. Introduction: a structural inflection in healthcare

1.1. The macro backdrop

Late 2025 finds the global healthcare market in a structural “fundamentals level-up,” not just a rate-cut bounce. After years of pressure under high rates, biotech began showing real turnaround signs in H2 2025.

Official fact: This report is based on Mirae Asset’s December research and major companies’ Corporate Day materials. Three drivers are working at the same time: (1) aggressive deal-making by big pharma to address looming Patent Cliffs, (2) newly mature modalities such as ADCs, blood-brain barrier (BBB) shuttles, and obesity drugs, and (3) supply-chain re-routing driven by the US Biosecure Act and broader geopolitical risk.

Interpretation: 2026 will be the year these shifts crystallize into actual earnings and large-scale tech-out (L/O) deals. Pharma/biotech is moving from the “dream zone” of R&D milestones into the “earnings zone” of commercialization and trillion-won licensing. Medical devices and digital health, meanwhile, face domestic saturation; overseas expansion and reimbursement coverage are now the survival keys.

2. Pharma/biotech: the platform-technology renaissance

2.1. The Q4 deal season and big-pharma strategy

Q4 has traditionally been the “deal high season” for global pharma/biotech. With the J.P. Morgan Healthcare Conference (JPMHC) in San Francisco around the corner in early 2026, big pharma typically signs major M&A or licensing deals at year-end to showcase growth.

Official fact: The keyword for Q4 2025 is “focus.” Pfizer acquiring Metsera and Novo Nordisk’s pursuit of Akero are bet-the-company moves to capture leadership in the next-generation obesity/MASH (metabolic dysfunction-associated steatohepatitis) market. In Korea, ABL Bio and LigaChem Biosciences delivered large licensing deals in the same period.

Interpretation: Korean biotech is now being recognized not as a “fast follower” but as a holder of First-in-Class or Best-in-Class technology that helps set the global trend.

2.2. Deep dive: BBB shuttles and ABL Bio

The biggest hurdle in central nervous system (CNS) diseases such as Alzheimer’s and Parkinson’s is that drugs barely reach the brain. The BBB is a powerful barrier; only about 0.1–0.2% of a typical antibody crosses it. That forces high dosing, which inevitably drives systemic toxicity.

The “BBB shuttle” solves this. An antibody (shuttle) binds to a receptor on the BBB surface and carries the therapeutic across like a Trojan horse, using endocytosis on the blood side and exocytosis on the brain side (transcytosis).

Official fact: Eli Lilly signed a total KRW 3.8T deal with ABL Bio plus an equity investment. Lilly already owns the Alzheimer’s drug donanemab but needed higher brain penetration to maximize efficacy. After Roche’s TfR-based trontinemab showed positive clinical data, Lilly moved to lock in a differentiated IGF1R platform for competitive advantage.

Interpretation: The deeper story is the potential combination with RNA therapeutics (siRNA, ASO). Past shuttle work mostly carried antibodies, but this deal opens the door to ferrying gene therapies that otherwise struggle to reach the brain. ABL Bio has been elevated from an antibody company to a global partner offering a brain-disease delivery platform.

2.3. ADC evolution: the linker decides the winner

Antibody-drug conjugates (ADCs) are “guided-missile” cancer drugs. First-generation ADCs suffered toxicity because the payload fell off too early and hit normal cells. Today’s hot trend is a stable linker that holds the payload tightly until the drug reaches the tumor cell, then cleaves precisely inside it.

Official fact: LigaChem Biosciences’ ConjuAll platform keeps the linker stable in blood and cleaves it only when it encounters a specific enzyme (beta-glucuronidase) inside the cancer cell. Combined with site-specific conjugation that attaches the payload at defined antibody positions, the platform delivers high homogeneity.

Interpretation: Versus Seagen or Daiichi Sankyo technology, this dramatically reduces blood toxicity and improves CMC yield. The recent licensing deals to J&J and Amgen are global big-pharma endorsements of that edge.

3. Company deep dives and behind-the-scenes

3.1. Samsung Biologics (207940): geopolitical tailwind plus a productivity gap

• Productivity secret (PCO compression): The 40–50% operating margin is not about plant size; it is about shortening Product Change Over (PCO) — the cleaning and sterilization between products. Cutting that time dramatically pushes utilization above 80% (effectively above 90%).
• The real Biosecure Act win: The US bill targets China’s WuXi Biologics and peers. Global pharma is diversifying away from China, and Samsung Biologics, with its scale, has emerged as the top alternative. The recent KRW 1.8T order is clear evidence of “Flight to Quality.”
• US plant dilemma and strategy: The market worries about margin dilution from US direct investment. Management plans to absorb thinner US-plant margins to win customers needing the “Made in USA” label, then mix-and-match with high-volume Songdo output to defend total profitability.

3.2. Celltrion (068270): Zymfentra’s US settlement and the PBM war

• Zymfentra’s identity: Zymfentra (Remsima SC) was approved in the US as a New Drug, not a biosimilar. That allows premium pricing but also forces it through the strict PBM listing process.
• PBM listing behind-the-scenes: US drug distribution is dominated by Pharmacy Benefit Managers (PBMs). Early Zymfentra prescriptions ran slower than expected because, even after a PBM listing agreement, it takes 2–3 months to get registered at hospital code level and reach patients (lagging effect). With the top-three PBMs listed by H2 2025, real prescription data should accelerate.
• COGS improvement: The high-cost inventory carried by Celltrion Healthcare pre-merger has been largely worked off by 2025, dropping COGS to the mid-30% range and opening a structural margin improvement window.

3.3. Oscotec (039200): Leclaza success and governance clean-up

• Leclaza (lazertinib) value: The lung-cancer drug co-developed with Yuhan was approved by the FDA in combination with J&J’s Rybrevant, opening the door to Korea’s first global blockbuster.
• Governance fix (deep dive): Subsidiary Genosco, the original developer of lazertinib, had partial ownership by the Oscotec chairman’s son, raising tunneling concerns. Oscotec is acquiring the related-party stake to make Genosco a wholly owned subsidiary or to merge it, with an independent special committee setting the purchase price — a critical governance clean-up that lets the full lazertinib royalty be recognized.
• Next pipeline ADEL-Y01: An antibody that leaves normal tau alone and selectively removes pathologic tau (MTBR) in Alzheimer’s. Depending on Phase 1, it could become the next big out-licensing event.

3.4. SEERS Technology (458870): subscription economics meets reimbursement

• Business-model innovation: Where past wearable ECG companies stopped at hardware sales, SEERS built an in-hospital patient-monitoring infrastructure. The “thync” system places gateways inside the hospital to track patient location and vital signs in real time.
• The reimbursement magic: The key is securing the EX871 code (remote heart-rate monitoring). Hospitals can bill roughly KRW 40,000–60,000 per patient per day, recovering the equipment cost in one to two months and turning a profit — a powerful adoption incentive.
• Symbiosis with Daewoong: SEERS solved the “tech company can’t sell” problem via an exclusive distribution contract with Daewoong Pharmaceutical, which prepays three years of device value and handles sales while SEERS focuses on R&D and manufacturing. Receivables turn in about two months, so cash flow is excellent.

4. Medical devices and aesthetics: domestic saturation vs. global expansion

4.1. Structural limits of the Korean aesthetics market

Official fact: In H2 2025, the Korean aesthetics market saw the supply shortage ease after the resident-doctor strike resolution, but demand-side growth is slowing. In the skin-booster segment, ECM (extracellular matrix) products (e.g., Juvelook) and PN products (Rejuran) are competing fiercely, with debate around regulatory issues such as nodule side-effects from larger ECM particles.

Interpretation: This noise is a valuation de-rating factor for companies with heavy domestic exposure. The two axes that separate winners from losers are overseas revenue mix and either reimbursement coverage or original-brand pricing power.

4.2. Classys (214150): a quantum jump via M&A

• Brazil distributor acquisition — margin migration: Classys bought its Brazil distributor outright. This is not just adding revenue; it shifts the margin recognition from wholesale (transfer price) to retail (market price). 2026 revenue should jump by about KRW 150B year-over-year from organic growth plus the M&A effect.
• Bundling strategy: The clinic network built around Shurink (HIFU) is now layered with Volnewmer (RF) and Quadse (microneedle RF) as a package. In the US, that combination protocol is a strong weapon versus competitors carrying single devices (Ulthera, Thermage).

4.3. PharmaResearch (214450): the “Rejuran” brand moat

• Originality matters: The PDRN/PN raw material is extracted from salmon testes; raw-material quality control and process know-how are high barriers. Even with low-priced copies on the market, consumers do not say “I came for a PN injection” — they say “I came for Rejuran.” The drug has achieved brand loyalty closer to a consumer good.
• Gray-market cleanup: Recent export volatility reflects a deliberate shutdown of informal “daigou” exports and a transition to formal master distributors. Short-term revenue takes a hit, but it is essential for protecting brand and pricing control over the long term.

5. 2026 outlook and investment strategy

5.1. Macro and investor psychology

A rate-cut bias favors long-duration biotech. But unlike the past “buy anything” era, money will polarize between (1) names with hard numbers (CDMO, aesthetics) and (2) names whose technology is endorsed by global big pharma (BBB, ADC).

5.2. Top Picks and watch list

5.3. Conclusion

2026 is the year Korean healthcare graduates from “possibility” to “proof.” Investors should focus on concrete data, the quality of partnerships, and cash flow — not on rosy roadmaps. Pharma/biotech licensing momentum and medical-device global earnings growth will form the two wings that lift the sector’s overall re-rating.

Appendix 1. Key technical glossary

• P-CAB (potassium-competitive acid blocker): Next-generation GERD therapy that fixes PPI weaknesses (slow onset, food interaction).
• ADC (antibody-drug conjugate): A drug that bolts a cytotoxic payload onto a tumor-seeking antibody. Linker technology is the safety pivot.
• BBB (blood-brain barrier): The shield that protects the brain and blocks drug delivery. Shuttle technology that crosses it is the key to brain-disease therapy.
• PBM (Pharmacy Benefit Manager): US prescription-drug benefit middlemen wielding huge power over pricing and formulary access between manufacturers and insurers.

Appendix 2. 2026 expected earnings (consensus reconstruction)

Published: December 5, 2025 · Source: Mirae Asset Securities Research Center reports and company IR materials · Reference: 20251204160124770_3694.pdf