# 內容更正與版本 / Content corrections and version

ADC-20261007-R1-LAYERED-HTML-R2-EVIDENCE-D15-SCOPE-2.0 · 2026-10-08 · 研究資料截至 / Research as of 2026-10-07

F08 的 Gilead/Tubulis 公告日期未經本次來源核實，已撤下該精確日期；保留 2026-05-21 完成日期，並分開列示現金對價、或有里程碑與淨會計口徑。

The precise Gilead/Tubulis announcement date in F08 was not verified within the source scope and has been removed. The May 21, 2026 completion date is retained; cash consideration, contingent milestones and net accounting remain distinct.

## ZH · 04　把工程名詞翻成可驗證的改善

R05原摘要未取得；將依賴該例的機制映射收窄為原有評估問題，保留量測欄。

[R05](https://pubmed.ncbi.nlm.nih.gov/26076429/)

**修正前 / Before**

| 偶聯位置、親水性、DAR | 產物異質性、聚集、過快清除 | DAR 分布、游離負載、穩定性及人體暴露。 |

**修正後 / After**

| 偶聯設計與 DAR | 產物是否均一、穩定，暴露是否足夠？ | DAR 分布、游離負載、穩定性及人體暴露。 |

## ZH · 04　把工程名詞翻成可驗證的改善

R05停止作F03正文依據；引用文獻起年隨剩餘最早R04改2016，研究截至與查核日不改。 / R05 is no longer active support for F03; the citation range now starts with the earliest retained source R04 (2016), without changing the research cutoff or check date.

[R05](https://pubmed.ncbi.nlm.nih.gov/26076429/)

**修正前 / Before**

[R02](#R02) [R04](#R04) [R05](#R05) [R06](#R06) [C10](#C10) [C11](#C11) [C12](#C12) [R10](#R10) · 文獻2015–2026；查核2026-10-07

**修正後 / After**

[R02](#R02) [R04](#R04) [R06](#R06) [C10](#C10) [C11](#C11) [C12](#C12) [R10](#R10) · 文獻2016–2026；查核2026-10-07

## ZH · 04　把工程名詞翻成可驗證的改善

只撤下未取得原摘要的Lyon研究例與其引用；保留原有工程評估問題，不將泛機制來源挪作該研究的證明。

[R05](https://pubmed.ncbi.nlm.nih.gov/26076429/)

**修正前 / Before**

高 DAR 的問題同樣如此。Lyon 等人的臨床前研究顯示，改善高負載 ADC 的疏水性可以改變清除與治療指數。判斷重點應落在整個分子的物理化學性質與體內行為。平均 DAR 相同的兩個產品，也未必具有相同分布、游離負載或儲存穩定性。[R05](#R05)[R02](#R02)

**修正後 / After**

高 DAR 的問題同樣如此。判斷重點應落在整個分子的物理化學性質與體內行為；需要比較 DAR 分布、游離負載、儲存穩定性與人體暴露，不能只比平均 DAR。

## ZH · 04　把工程名詞翻成可驗證的改善

C09原頁429且沒有可用的真摘要保存件；撤下Gastric04特定條件與OS/HR數值例，不判其錯誤。原數據檔保留並另列證據缺口。

[C09](https://pubmed.ncbi.nlm.nih.gov/40454632/)

**修正前 / Before**

患者篩選本身也能形成差異。第二線胃癌／胃食道交界癌試驗Gastric04，要求在含trastuzumab的第一線治療後進展，並重新活檢確認HER2陽性；T-DXd相對ramucirumab＋paclitaxel的OS為14.7對11.4個月，HR 0.70（95% CI 0.55–0.90）。曾經HER2陽性，不等於進展後仍符合這項試驗的靶點條件。[C09](#C09)

**修正後 / After**

患者篩選本身也能形成差異。評估這種差異，應把靶點檢測時間、重新檢測要求與試驗入組條件一起看。

## ZH · 06　最有價值的缺口：ADC 之後怎麼治？

R03 Table 1/case detail unavailable; specified exact removal only.

[R03](https://pmc.ncbi.nlm.nih.gov/articles/PMC12079096/)

**修正前 / Before**

Abelman 等人在經選擇、具 ADC 治療後血漿基因檢測的31位轉移性乳癌患者中，檢出4位 TOP1 突變；另一個未用 ADC 的420人隊列為3位。兩組分別為12.9%與0.7%，來源與選取方式不同。功能實驗支持部分突變可能對 SN38 與 DXd 負載形成交叉抗藥；四個病例中有一人的基線已可偵測低量突變。[R03](#R03)

**修正後 / After**

Abelman 等人在經選擇、具 ADC 治療後血漿基因檢測的31位轉移性乳癌患者中，檢出4位 TOP1 突變；另一個未用 ADC 的420人隊列為3位。兩組分別為12.9%與0.7%，來源與選取方式不同。功能實驗支持部分突變可能對 SN38 與 DXd 負載形成交叉抗藥。[R03](#R03)

## ZH · 11　最高總額，沒有告訴你的買單內容

Clarify scope of the calculated 20+30+415 maximum; the source separately provides tiered sales royalties. Raw values remain unchanged.

[D14](https://investors.gilead.com/news/news-details/2024/Gilead-and-Tubulis-Enter-Into-Exclusive-Option-and-License-Agreement-to-Develop-ADC-Candidate-for-Select-Solid-Tumor-Target/default.aspx)

**修正前 / Before**

| Gilead／Tubulis 選擇權<br>2024-12-03 | 20簽約＋30行權＋最高415里程碑；最高465。未核實後續行權付款。[D14](#D14) | 單一未公開靶點的研究 ADC；先合作，再決定是否接手。 |

**修正後 / After**

| Gilead／Tubulis 選擇權<br>2024-12-03 | 20簽約＋30行權＋最高415里程碑；固定及條件款合計最高465，銷售權利金另計。未核實後續行權付款。[D14](#D14) | 單一未公開靶點的研究 ADC；先合作，再決定是否接手。 |

## ZH · 12　台灣創新：不同技術位置，需要不同證據

ACCESS原稿未直接支持2025年12月初始公告及同一交易對應；保留已證授權內容與付款邊界。

[T04](https://www.accessnewswire.com/newsroom/en/healthcare-and-pharmaceutical/obi-pharma-and-tegmine-therapeutics-sign-exclusive-global-license-agr-1126261)

**修正前 / Before**

浩鼎先前公告的TegMine授權，呈現一種可行合作接口：由夥伴提供抗醣抗體，接上浩鼎的偶聯與連接子技術。公開完整發稿為2026年1月，最初公司公告見於2025年12月，屬同一交易；金額與實收現金未公開，不宜改寫成一筆可計價的2026新訂單。[T04](#T04)

**修正後 / After**

浩鼎先前公告的TegMine授權，呈現一種可行合作接口：由夥伴提供抗醣抗體，接上浩鼎的偶聯與連接子技術。可核對的公司公開完整發稿日期為2026年1月12日；詳細財務條款未披露，發稿亦未確認實收現金，不宜據此推算已實現訂單金額。[T04](#T04)

## ZH · 12　台灣創新：不同技術位置，需要不同證據

指定T05原稿未提GNX102或其裸抗體身份；只去除未有直接原文支持的分子標籤，保留產品別證據判斷。

[T05](https://glyconex.com.tw/news/2026/2026-08-03-gnx1021-first-patient-dosed)

**修正前 / Before**

醣聯GNX1021則辨識腫瘤的bLeB/Y醣抗原，回答的是辨識什麼。公司於2026年8月3日公告在日本完成一期首位給藥，這是從模型走向人體的重要節點。其後應追蹤安全性、劑量與活性；舊GNX102裸抗體研究不能拿來填補GNX1021的ADC人體證據。[T05](#T05)

**修正後 / After**

醣聯GNX1021則辨識腫瘤的bLeB/Y醣抗原，回答的是辨識什麼。公司於2026年8月3日公告在日本完成一期首位給藥，這是從模型走向人體的重要節點。其後應追蹤安全性、劑量與活性；其他分子的臨床資料不能替代GNX1021本身的ADC人體證據。[T05](#T05)

## ZH · 12　台灣創新：不同技術位置，需要不同證據

T07直接支持公告中的臨床前資料層級，未獨立證明10月7日仍未進入人體；不新增來源或刪除案例。

[T07](https://www.formosapharma.com/formosa-pharmaceuticals-announces-presentation-of-tsy-310-at-the-2026-asco-annual-meeting/)

**修正前 / Before**

TSY-110（EG12043）參照T-DM1／Kadcyla，由台新藥與台康共同開發。台新藥2026年8月28日公告遞交歐洲臨床試驗申請；這一狀態尚不等於核准或給藥。其核心工作是分析相似性、PK、安全性與免疫原性；另一路EGFR×ROR1的TSY-310仍為臨床前創新ADC，應獨立評估。[T06](#T06)[T07](#T07)

**修正後 / After**

TSY-110（EG12043）參照T-DM1／Kadcyla，由台新藥與台康共同開發。台新藥2026年8月28日公告遞交歐洲臨床試驗申請；這一狀態尚不等於核准或給藥。其核心工作是分析相似性、PK、安全性與免疫原性；另一路EGFR×ROR1的TSY-310於2026年5月公告呈現臨床前資料，應獨立評估。[T06](#T06)[T07](#T07)

## ZH · 14　未來十二個月，什麼事件會改變判斷？

只移除本輪 C16 不能直接支持的舊版時程比較；保留本版 H1 2027、C13 已驗撤件與 C23 登錄日期。

[C16](https://www.astrazeneca.com/content/dam/az/PDF/2026/h1q2/H1-and-Q2-2026-results-clinical-trials-appendix.pdf)

**修正前 / Before**

時程變動本身也有研究價值。最近已查得的AZ指引把Lung07／08列在2027上半年；其中Lung07已不宜沿用舊版2026下半年的預期。I-DXd在9月撤回申請後，原10月10日PDUFA已不再是有效的待發生審查節點；Lung02最新登錄主要完成日估2028年1月，也不應塞進本次十二個月表。[C16](#C16)[C13](#C13)[C23](#C23)

**修正後 / After**

時程變動本身也有研究價值。最近已查得的AZ指引把Lung07／08列在2027上半年。I-DXd在9月撤回申請後，原10月10日PDUFA已不再是有效的待發生審查節點；Lung02最新登錄主要完成日估2028年1月，也不應塞進本次十二個月表。[C16](#C16)[C13](#C13)[C23](#C23)

## ZH · 附錄 A　全球公司與合作地圖

Use the directly stated completed all-common-stock acquisition instead of an exchange-listing status not explicitly established by this release.

[D07](https://www.pfizer.com/news/press-release/press-release-detail/pfizer-completes-acquisition-seagen)

**修正前 / Before**

| Pfizer／Seagen | Seagen已於2023-12納入Pfizer，非獨立上市標的。[D07](#D07) | 既有組合向前線延伸。 |

**修正後 / After**

| Pfizer／Seagen | Pfizer於2023-12完成取得Seagen全部普通股。[D07](#D07) | 既有組合向前線延伸。 |

## ZH · 附錄 A　全球公司與合作地圖

公司公告明確劃分中國與中國以外開發責任，取代未限定地域的「全球合作」概括。

[C11](https://news.bms.com/news/details/2026/Izalontamab-Brengitecan-Iza-Bren-Demonstrates-Statistically-Significant-and-Clinically-Meaningful-Improvements-in-Overall-Survival-and-Progression-Free-Survival-in-Patients-with-Triple-Negative-Breast-Cancer-and-Esophageal-Squamous-Cell-Carcinoma/default.aspx)

**修正前 / Before**

| BMS／SystImmune | Iza-bren三期結果的全球合作與開發。[C11](#C11) | 患者與對照的適用範圍。 |

**修正後 / After**

| BMS／SystImmune | Iza-bren 在中國以外共同開發；中國 PANKU-Breast02／PANKU-Esophagus01 由 Biokin 主辦。[C11](#C11) | 患者與對照的適用範圍。 |

## ZH · 附錄 B　台灣能力與證據地圖

與ZH-L0457同一來源缺項；GNX1021已證進度、標的及公司上市櫃身分均保留。

[T05](https://glyconex.com.tw/news/2026/2026-08-03-gnx1021-first-patient-dosed)

**修正前 / Before**

| 醣聯<br>TPEx上櫃4168 [T19](#T19) | GNX1021靶向bLeB/Y醣抗原；公司2026-08-03公告首位給藥。[T05](#T05) | 人體安全性、劑量與初步療效；非GNX102裸抗體數據。 |

**修正後 / After**

| 醣聯<br>TPEx上櫃4168 [T19](#T19) | GNX1021靶向bLeB/Y醣抗原；公司2026-08-03公告首位給藥。[T05](#T05) | 人體安全性、劑量與初步療效；需為GNX1021本身的ADC數據。 |

## ZH · 附錄 B　台灣能力與證據地圖

將資料階段綁定已讀公告，避免把5月資料誤當10月持續階段已核。

[T07](https://www.formosapharma.com/formosa-pharmaceuticals-announces-presentation-of-tsy-310-at-the-2026-asco-annual-meeting/)

**修正前 / Before**

| 台新藥<br>TWSE上市6838 [T17](#T17) | TSY-110／EG12043為參照T-DM1的生物相似藥候選，歐洲CTA已遞交；TSY-310臨床前。[T06](#T06)[T07](#T07) | CTA後進展與相似性；雙特異資產另待人體證據。 |

**修正後 / After**

| 台新藥<br>TWSE上市6838 [T17](#T17) | TSY-110／EG12043為參照T-DM1的生物相似藥候選，歐洲CTA已遞交；TSY-310於2026年5月公告臨床前資料。[T06](#T06)[T07](#T07) | CTA後進展與相似性；雙特異資產另待人體證據。 |

## ZH · 附錄 B　台灣能力與證據地圖

T15本次讀到的PDF為10月7日產製；原10月6日快照未取得。保留原source/data_date於索引，另列本次觀察日期。

[T15](https://www.twse.com.tw/pdf/ch/4746_ch.pdf)

**修正前 / Before**

上市櫃來源與能力來源分列。台康於2025-07-21轉上市。TWSE資料快照為2026-10-06／07；未標更新日的公司頁僅記本次存取日，不把它當作能力或產能的更新日。

**修正後 / After**

上市櫃來源與能力來源分列。台康於2025-07-21轉上市。本次可核的TWSE個股PDF產製日為2026-10-07；未標更新日的公司頁僅記本次存取日，不把它當作能力或產能的更新日。

## ZH · 附錄 C　公式、來源範圍與更新方法

Retain formula and numerical result; expose royalties exclusion in the reproducible calculation table.

[D14](https://investors.gilead.com/news/news-details/2024/Gilead-and-Tubulis-Enter-Into-Exclusive-Option-and-License-Agreement-to-Develop-ADC-Candidate-for-Select-Solid-Tumor-Target/default.aspx)

**修正前 / Before**

| 2024 Tubulis選擇權名義最高 | 20＋30＋415 [D14](#D14) | 465百萬美元；含條件款，未當實收。 |

**修正後 / After**

| 2024 Tubulis選擇權名義最高 | 20＋30＋415 [D14](#D14) | 465百萬美元；含條件款、銷售權利金另計，未當實收。 |

## EN · 04  Translate Engineering Labels into Testable Improvements

The R05 abstract was not obtained; narrow the source-dependent mapping to the existing assessment questions and retain the measurement column.

[R05](https://pubmed.ncbi.nlm.nih.gov/26076429/)

**修正前 / Before**

| Conjugation site, hydrophilicity, DAR | Product heterogeneity, aggregation, overly rapid clearance | DAR distribution, free payload, stability and human exposure. |

**修正後 / After**

| Conjugation design and DAR | Are product composition and stability controlled, and is exposure adequate? | DAR distribution, free payload, stability and human exposure. |

## EN · 04  Translate Engineering Labels into Testable Improvements

R05停止作F03正文依據；引用文獻起年隨剩餘最早R04改2016，研究截至與查核日不改。 / R05 is no longer active support for F03; the citation range now starts with the earliest retained source R04 (2016), without changing the research cutoff or check date.

[R05](https://pubmed.ncbi.nlm.nih.gov/26076429/)

**修正前 / Before**

[R02](#R02) [R04](#R04) [R05](#R05) [R06](#R06) [C10](#C10) [C11](#C11) [C12](#C12) [R10](#R10) · Literature: 2015–2026; checked 2026-10-07.

**修正後 / After**

[R02](#R02) [R04](#R04) [R06](#R06) [C10](#C10) [C11](#C11) [C12](#C12) [R10](#R10) · Literature: 2016–2026; checked 2026-10-07.

## EN · 04  Translate Engineering Labels into Testable Improvements

Remove only the Lyon study example and its citation because the original abstract was not obtained. Retain the existing engineering questions without treating a general mechanism source as evidence for that study.

[R05](https://pubmed.ncbi.nlm.nih.gov/26076429/)

**修正前 / Before**

High DAR raises a similar issue. Preclinical work by Lyon and colleagues showed that reducing the hydrophobicity of highly loaded ADCs can alter clearance and the therapeutic index. The assessment should focus on the physicochemical properties and in vivo behavior of the whole molecule. Two products with the same average DAR may still differ in their distribution, free payload or storage stability.[R05](#R05)[R02](#R02)

**修正後 / After**

High DAR raises a similar issue. The assessment should focus on the physicochemical properties and in vivo behavior of the whole molecule: DAR distribution, free payload, storage stability and human exposure should be compared, rather than average DAR alone.

## EN · 04  Translate Engineering Labels into Testable Improvements

The C09 page returned 429 and no genuine saved abstract was available. Remove the Gastric04-specific conditions and OS/HR example without declaring them false. Preserve the original data files and record the evidence gap separately.

[C09](https://pubmed.ncbi.nlm.nih.gov/40454632/)

**修正前 / Before**

Patient selection can itself create a meaningful difference. Gastric04, a second-line gastric/gastroesophageal junction cancer trial, required progression after first-line trastuzumab-containing therapy and a repeat biopsy confirming HER2 positivity. OS with T-DXd versus ramucirumab + paclitaxel was 14.7 versus 11.4 months, with an HR of 0.70 (95% CI 0.55–0.90). Having been HER2-positive previously does not mean a patient's tumor still meets this trial's target criteria after progression.[C09](#C09)

**修正後 / After**

Patient selection can itself create a meaningful difference. To assess that difference, consider the timing of target testing, any retesting requirements and trial eligibility criteria together.

## EN · 06  A Valuable Gap: What Comes after an ADC?

R03 Table 1/case detail unavailable; specified exact removal only.

[R03](https://pmc.ncbi.nlm.nih.gov/articles/PMC12079096/)

**修正前 / Before**

Abelman and colleagues detected TOP1 mutations in 4 of 31 selected patients with metastatic breast cancer who had plasma genomic testing after ADC treatment. A separate cohort of 420 patients who had not received ADCs included 3 such cases. The proportions were 12.9% and 0.7%, respectively, but the cohorts differed in their sources and selection. Functional experiments supported the possibility that some mutations confer cross-resistance to SN38 and DXd payloads; one of the four patients already had a low-level detectable mutation at baseline.[R03](#R03)

**修正後 / After**

Abelman and colleagues detected TOP1 mutations in 4 of 31 selected patients with metastatic breast cancer who had plasma genomic testing after ADC treatment. A separate cohort of 420 patients who had not received ADCs included 3 such cases. The proportions were 12.9% and 0.7%, respectively, but the cohorts differed in their sources and selection. Functional experiments supported the possibility that some mutations confer cross-resistance to SN38 and DXd payloads.[R03](#R03)

## EN · 11  What the Headline Deal Value Does Not Tell You

Same royalty-scope clarification; agreed amounts are not represented as receipts.

[D14](https://investors.gilead.com/news/news-details/2024/Gilead-and-Tubulis-Enter-Into-Exclusive-Option-and-License-Agreement-to-Develop-ADC-Candidate-for-Select-Solid-Tumor-Target/default.aspx)

**修正前 / Before**

| Gilead / Tubulis option<br>2024-12-03 | 20 upfront + 30 on exercise + up to 415 milestones; maximum 465. Subsequent option-exercise payment not verified.[D14](#D14) | One research ADC against an undisclosed target; collaborate first, then decide whether to assume development. |

**修正後 / After**

| Gilead / Tubulis option<br>2024-12-03 | 20 upfront + 30 on exercise + up to 415 milestones; specified fees and milestones total up to 465, with sales royalties additional. Subsequent option-exercise payment not verified.[D14](#D14) | One research ADC against an undisclosed target; collaborate first, then decide whether to assume development. |

## EN · 12  Taiwan’s Innovation: Different Technical Roles Need Different Evidence

The ACCESS release does not directly support the December 2025 initial-announcement date or the same-transaction linkage; the verified license and payment boundary are retained.

[T04](https://www.accessnewswire.com/newsroom/en/healthcare-and-pharmaceutical/obi-pharma-and-tegmine-therapeutics-sign-exclusive-global-license-agr-1126261)

**修正前 / Before**

OBI Pharma's previously announced TegMine license illustrates one possible collaboration interface: a partner supplies a glycan-targeting antibody, combined with OBI Pharma's conjugation and linker technologies. The full public release appeared in January 2026, following the initial company announcement in December 2025; both refer to the same transaction. Financial terms and cash received were not disclosed, so it should not be recast as a new, quantifiable order in 2026.[T04](#T04)

**修正後 / After**

OBI Pharma's previously announced TegMine license illustrates one possible collaboration interface: a partner supplies a glycan-targeting antibody, combined with OBI Pharma's conjugation and linker technologies. The verifiable company-issued public release is dated January 12, 2026. Detailed financial terms were not disclosed, and the release does not confirm cash received; it cannot establish a realized order amount.[T04](#T04)

## EN · 12  Taiwan’s Innovation: Different Technical Roles Need Different Evidence

T05 does not discuss GNX102 or identify it as an unconjugated antibody; preserve the product-specific evidence judgment without that unsupported label.

[T05](https://glyconex.com.tw/news/2026/2026-08-03-gnx1021-first-patient-dosed)

**修正前 / Before**

GlycoNex's GNX1021 instead recognizes the tumor-associated bLeB/Y glycan antigen, addressing what the ADC recognizes. On 2026-08-03, the company announced that the first patient had been dosed in Japan in its Phase 1 trial, an important transition from models to humans. Safety, dose and activity are the next evidence to track. Earlier studies of the unconjugated GNX102 antibody cannot fill the human-evidence gap for the GNX1021 ADC.[T05](#T05)

**修正後 / After**

GlycoNex's GNX1021 instead recognizes the tumor-associated bLeB/Y glycan antigen, addressing what the ADC recognizes. On 2026-08-03, the company announced that the first patient had been dosed in Japan in its Phase 1 trial, an important transition from models to humans. Safety, dose and activity are the next evidence to track. Clinical data from other molecules cannot replace human evidence for the GNX1021 ADC itself.[T05](#T05)

## EN · 12  Taiwan’s Innovation: Different Technical Roles Need Different Evidence

T07 directly supports the evidence stage in its dated announcement, not an independently verified current absence of human development.

[T07](https://www.formosapharma.com/formosa-pharmaceuticals-announces-presentation-of-tsy-310-at-the-2026-asco-annual-meeting/)

**修正前 / Before**

TSY-110 (EG12043), jointly developed by Formosa Pharmaceuticals and EirGenix, references T-DM1 / Kadcyla. On 2026-08-28, Formosa Pharmaceuticals announced the submission of a clinical trial application in Europe; submission does not establish authorization or patient dosing. The core work concerns analytical similarity, PK, safety and immunogenicity. The separate EGFR × ROR1 asset TSY-310 remains a preclinical innovative ADC and requires its own assessment.[T06](#T06)[T07](#T07)

**修正後 / After**

TSY-110 (EG12043), jointly developed by Formosa Pharmaceuticals and EirGenix, references T-DM1 / Kadcyla. On 2026-08-28, Formosa Pharmaceuticals announced the submission of a clinical trial application in Europe; submission does not establish authorization or patient dosing. The core work concerns analytical similarity, PK, safety and immunogenicity. The separate EGFR × ROR1 asset TSY-310 was represented by preclinical data in the May 2026 announcement and requires its own assessment.[T06](#T06)[T07](#T07)

## EN · 14  Which Events Could Change the Assessment over Twelve Months?

只移除本輪 C16 不能直接支持的舊版時程比較；保留本版 H1 2027、C13 已驗撤件與 C23 登錄日期。

[C16](https://www.astrazeneca.com/content/dam/az/PDF/2026/h1q2/H1-and-Q2-2026-results-clinical-trials-appendix.pdf)

**修正前 / Before**

Changes in timing are themselves informative. The latest AZ guidance located places Lung07/08 in H1 2027; the earlier H2 2026 expectation for Lung07 is no longer appropriate. Following the withdrawal of the I-DXd application in September, its former 2026-10-10 PDUFA date is no longer a valid upcoming review milestone. The latest Lung02 registry entry estimates primary completion in January 2028, which also falls outside this twelve-month watchlist.[C16](#C16)[C13](#C13)[C23](#C23)

**修正後 / After**

Changes in timing are themselves informative. The latest AZ guidance located places Lung07/08 in H1 2027. Following the withdrawal of the I-DXd application in September, its former 2026-10-10 PDUFA date is no longer a valid upcoming review milestone. The latest Lung02 registry entry estimates primary completion in January 2028, which also falls outside this twelve-month watchlist.[C16](#C16)[C13](#C13)[C23](#C23)

## EN · Appendix A  Global Company and Collaboration Map

Same direct-ownership narrowing as the Traditional Chinese statement; no new corporate event or date added.

[D07](https://www.pfizer.com/news/press-release/press-release-detail/pfizer-completes-acquisition-seagen)

**修正前 / Before**

| Pfizer / Seagen | Seagen became part of Pfizer in December 2023 and is no longer independently listed.[D07](#D07) | Extension of the existing portfolio into earlier treatment lines. |

**修正後 / After**

| Pfizer / Seagen | Pfizer completed its acquisition of all outstanding Seagen common stock in December 2023.[D07](#D07) | Extension of the existing portfolio into earlier treatment lines. |

## EN · Appendix A  Global Company and Collaboration Map

公司公告明確劃分中國與中國以外開發責任，取代未限定地域的「全球合作」概括。

[C11](https://news.bms.com/news/details/2026/Izalontamab-Brengitecan-Iza-Bren-Demonstrates-Statistically-Significant-and-Clinically-Meaningful-Improvements-in-Overall-Survival-and-Progression-Free-Survival-in-Patients-with-Triple-Negative-Breast-Cancer-and-Esophageal-Squamous-Cell-Carcinoma/default.aspx)

**修正前 / Before**

| BMS / SystImmune | Global collaboration and development involving Iza-bren Phase 3 results.[C11](#C11) | Applicability of the patient populations and comparators. |

**修正後 / After**

| BMS / SystImmune | Joint development of Iza-bren outside China; Biokin sponsors PANKU-Breast02 and PANKU-Esophagus01 in China.[C11](#C11) | Applicability of the patient populations and comparators. |

## EN · Appendix B  Taiwan Capabilities and Evidence Map

Same narrow source gap as EN-L0457; preserve verified GNX1021 target, progress and listing fields.

[T05](https://glyconex.com.tw/news/2026/2026-08-03-gnx1021-first-patient-dosed)

**修正前 / Before**

| GlycoNex<br>TPEx-listed 4168 [T19](#T19) | GNX1021 targets the bLeB/Y glycan antigen; company announced first patient dosed on 2026-08-03.[T05](#T05) | Human safety, dose and preliminary efficacy; separate from data on the unconjugated GNX102 antibody. |

**修正後 / After**

| GlycoNex<br>TPEx-listed 4168 [T19](#T19) | GNX1021 targets the bLeB/Y glycan antigen; company announced first patient dosed on 2026-08-03.[T05](#T05) | Human safety, dose and preliminary efficacy; requires data on the GNX1021 ADC itself. |

## EN · Appendix B  Taiwan Capabilities and Evidence Map

Bind the evidence-stage statement to the announcement actually read.

[T07](https://www.formosapharma.com/formosa-pharmaceuticals-announces-presentation-of-tsy-310-at-the-2026-asco-annual-meeting/)

**修正前 / Before**

| Formosa Pharmaceuticals<br>TWSE-listed 6838 [T17](#T17) | TSY-110 / EG12043 is a biosimilar candidate referencing T-DM1; European CTA submitted. TSY-310 is preclinical.[T06](#T06)[T07](#T07) | Progress after CTA submission and evidence of similarity; the bispecific asset separately awaits human evidence. |

**修正後 / After**

| Formosa Pharmaceuticals<br>TWSE-listed 6838 [T17](#T17) | TSY-110 / EG12043 is a biosimilar candidate referencing T-DM1; European CTA submitted. TSY-310 preclinical data were announced in May 2026.[T06](#T06)[T07](#T07) | Progress after CTA submission and evidence of similarity; the bispecific asset separately awaits human evidence. |

## EN · Appendix B  Taiwan Capabilities and Evidence Map

The T15 PDF read in this check was generated on October 7; the October 6 snapshot was not obtained. Retain the original source/data date in the index and record the observed date separately.

[T15](https://www.twse.com.tw/pdf/ch/4746_ch.pdf)

**修正前 / Before**

Securities-status sources are separate from capability sources. EirGenix transferred to the TWSE on 2025-07-21. TWSE snapshots are dated 2026-10-06 / 07. For company pages with no update date, only the access date is recorded; it is not treated as the date on which capability or capacity was updated.

**修正後 / After**

Securities-status sources are separate from capability sources. EirGenix transferred to the TWSE on 2025-07-21. The TWSE company-profile PDFs available for this check were generated on 2026-10-07. For company pages with no update date, only the access date is recorded; it is not treated as the date on which capability or capacity was updated.

## EN · Appendix C  Formulas, Source Scope and Update Method

Faithful English scope clarification for the unchanged nominal calculation.

[D14](https://investors.gilead.com/news/news-details/2024/Gilead-and-Tubulis-Enter-Into-Exclusive-Option-and-License-Agreement-to-Develop-ADC-Candidate-for-Select-Solid-Tumor-Target/default.aspx)

**修正前 / Before**

| 2024 Tubulis option: nominal maximum | 20 + 30 + 415 [D14](#D14) | USD 465 million; includes conditional payments and is not treated as cash received. |

**修正後 / After**

| 2024 Tubulis option: nominal maximum | 20 + 30 + 415 [D14](#D14) | USD 465 million; includes conditional payments, excludes sales royalties, and is not treated as cash received. |