KELUN-BIOTECH(6990.HK):INNOVATIVE BISPECIFIC ADC PRODUCT LICENSED TO MSD
KELUN-BIOTECH(6990.HK):INNOVATIVE BISPECIFIC ADC PRODUCT LICENSED TO MSD
Maintain BUY. We remain confident about SKB264's global development and the approval in China. We raise our DCF-based TP from HK$246.13 to HK$243.38 (WACC: 10.31%, terminal growth rate: 4.0%).Kelun-Biotech recorded RMB1.38bn (+32% YoY) revenue in 1H24, including a total of US$90mn (or RMB641mn) milestone payments from MSD regarding multiple collaborated pipelines. In 1H24, Kelun-Biotech spent RMB652mn on R&D, +33% YoY, mainly driven by an uptick in clinical trials. The company is gearing up for the near-term launch of several key assets in China, including sac-TMT (TROP2 ADC), A166 (HER2 ADC), A167 (PD-L1 mAb) and A140 (cetuximab biosimilar) in 2H24 or 1H25. In preparation, the company has assembled a commercial team of 110+ people, with plans to expand the salesforce to around 400 employees by end-2024. Therefore, in 1H24, the company recorded RMB41mn in selling expenses (vs 0 in 1H23). Kelun-Biotech achieved RMB310mn net profit in 1H24. The company received RMB492mn in net proceeds from the placement of new H shares in May 2024. As of Jun 2024, Kelun-Biotech had a robust cash balance (incl. financial assets) of RMB2.9bn. Following Kelun Pharma's subscription to new domestic shares, the company expects to receive an additional RMB601mn in net proceeds.
科倫製藥在2024年上半年實現了人民幣13.8億元的營業收入，同比增長32%，其中包括羅氏製藥公司關於多個合作項目的里程碑付款，總計9000萬美元（或6.41億元人民幣）。在2024年上半年，科倫製藥在研發方面花費了6.52億元，同比增長33%，主要是由於臨床試驗的增加。該公司正準備在中國推出幾個重要資產的近期計劃，包括2H24或1H25推出的sac-TMt（TROP2 ADC）、A166（HER2 ADC）、A167（PD-L1 mAb）和A140（西妥昔單抗生物類似物）。爲此，該公司已經組建了一個超過110人的銷售團隊，並計劃在2024年底將銷售團隊擴大到約400名員工。因此，2024年上半年，該公司的銷售費用爲4100萬元（與2023年上半年相比），實現了3.1億元的淨利潤。2024年5月，科倫製藥通過發行新H股獲得了人民幣4.92億元的淨收益。截至2024年6月，科倫製藥的現金餘額（包括金融資產）爲29億元。隨着科倫製藥認購新的境內股份，該公司預計將獲得額外的6.01億元淨收益。
The second BLA of sac-TMT submitted in China. Following the BLA submission of sac-TMT for 3L+ TNBC in Nov 2023, Kelun-Biotech recently submitted the second BLA of sac-TMT for 3L+ post-chemo and TKI-resistant EGFRm NSCLC in Aug 2024. Concurrently, Kelun-Biotech is preparing another BLA submission for sac-TMT for the treatment of 2L TKI-resistant EGFRm NSCLC. For EGFR-wild type NSCLC, the company has initiated a Ph3 trial in China to compare sac-TMT + Keytruda vs Keytruda in 1L PD-L1+ (TPS>=1%) NSCLC. Additionally, the CDE has granted approval for a Ph3 study of sac-TMT + Keytruda for first-line PD-L1-negative (TPS<1%) nsq-NSCLC, with the FPI expected soon. It's noteworthy that sac-TMT (Q3W) + A167 (PD-L1 mAb) achieved 15.4 months of mPFS in 1L NSCLC in a Ph2 study, significantly surpassing the SoC and other TROP2 ADC competitors (CMBI report link).
sac-TMt在中國提交了第二個BLA申請。繼2023年11月提交第一線治療三陰性乳腺癌的sac-TMt BLA申請後，科倫製藥於2024年8月提交了sac-TMt治療三線及以上後化療和EGFRm NSCLC耐藥的第二個BLA申請。與此同時，科倫製藥正準備提交另一個sac-TMt治療二線EGFRm NSCLC耐藥的BLA申請。對於EGFR野生型NSCLC，該公司在中國已經啓動了一個Phase 3臨床試驗，比較sac-TMt + Keytruda和Keytruda在一線PD-L1+（TPS≥1%）NSCLC患者中的療效。此外，國家藥品監督管理局已批准開展一項Phase 3研究，研究sac-TMt + Keytruda治療一線PD-L1陰性（TPS＜1%）非鱗狀非小細胞肺癌的療效，首例病例入組即將實施。值得注意的是，sac-TMt（每3周） + A167（PD-L1 mAb）在一項Phase 2研究中在一線NSCLC患者中取得了15.4個月的中位進展生存期，顯著超過標準療法以及其他TROP2 ADC競爭對手（CMBI報告鏈接）。
Out-licensed innovative bispecific ADC to MSD. MSD has initiated 10 global Ph3 trials of sac-TMT. These trials encompass a range of indications including NSCLC with five trials, TNBC, HR+/HER2- BC, GC, EC, and CC. The broad spectrum of clinical trials underscores MSD's commitment to advance sac-TMT's development. We expect MSD to initiate additional Ph3 trails of sac-TMT. MSD has exercised its option to in-license the ex-China rights of SKB571, a novel bispecific ADC at IND-enabling stage targeting lung and gastrointestinal tumors. For this, MSD will make an exercise payment of US$37.5mn to Kelun-Biotech, in addition to future milestone and royalty payments. Concurrently, MSD has returned the global rights for SKB315 (CLDN18.2 ADC) to Kelun-Biotech which will continue its development in China. Additionally, MSD/Kelun-Biotech are investigating SKB410/MK-3120 (Nectin4 ADC) in Ph1a study. Kelun-Biotech plans to submit IND applications for other four preclinical ADC assets under its licensed collaboration with MSD soon, and to explore new collaboration opportunities with MSD.
科倫製藥授予羅氏製藥一項創新的雙特異性抗體藥物聯合物（ADC）的全球獲得授權。羅氏製藥已經啓動了10個sac-TMt的全球第3期臨床試驗，涵蓋了一系列適應症，包括5個非小細胞肺癌試驗、三陰性乳腺癌、HR+/HER2-乳腺癌、胃癌、食道癌和結直腸癌。臨床試驗的廣泛範圍凸顯了羅氏製藥推進sac-TMt開發的決心。我們預計羅氏製藥將啓動其他sac-TMt的第3期臨床試驗。羅氏製藥選擇行使購買權，授權獲得科倫製藥處於IND-可行性階段的全球以外權益的SKB571，這是一種針對肺部和胃腸道腫瘤的新型雙特異性抗體藥物聯合物（ADC）。爲此，羅氏製藥將向科倫製藥支付3750萬美元的購買費，並將支付未來的里程碑費和特許權使用費。與此同時，羅氏製藥已將SKB315（CLDN18.2 ADC）的全球權益返還給科倫製藥，後者將繼續在中國開展該藥物的開發。此外，羅氏製藥/科倫製藥正參與一項Phase 1a研究，評估SKB410/Mk-3120（Nectin4 ADC）的療效。科倫製藥計劃儘快爲與羅氏製藥的合作項目中的其他四個臨床前ADC資產提交IND申請，並探索與羅氏製藥的新合作機會。
Maintain BUY. We remain confident about SKB264's global development and the approval in China. We raise our DCF-based TP from HK$246.13 to HK$243.38 (WACC: 10.31%, terminal growth rate: 4.0%).
繼續買入。我們對SKB264在全球範圍內的發展和在中國的批准保持信心。我們將基於現金流折現法的目標價從246.13港元提高到243.38港元（資本成本：10.31%，終端增長率：4.0%）。
譯文內容由第三人軟體翻譯。