Going Global Weekly: Pharma Licensing and Overseas Registrations Land in Clusters as Overseas and Secondary Listings Advance Together-20261108

Overseas M&A

1. MMG (01208.HK): Disclosed on November 3 that the long-stop date for the acquisition of Anglo American's Brazilian nickel business has been extended from October 31, 2026 to December 31. Completion remains subject to the satisfaction of conditions precedent including merger control approvals in several jurisdictions and acceptance of filings by the National Development and Reform Commission and the Ministry of Commerce; given that the other conditions have all been met, the European Commission's review has been extended to a second phase and must be completed by December 21. Under the share purchase agreement, either party may elect to terminate the agreement after the long-stop date.

Overseas Cooperation

1. QYUNS-B (02509.HK): Voluntary announcement on November 5 that it entered into a global exclusive licence agreement with Caldera Therapeutics in respect of preclinical bispecific antibody programmes targeting TL1A and IL-17 (IL-17A and IL-17A/F), under which the latter acquires the rights to research, develop, register, manufacture and commercialise worldwide. The company will receive a one-off, non-refundable and non-creditable upfront payment of USD 30 million and is eligible to receive up to USD 750 million in additional payments upon achievement of clinical development, regulatory and commercial milestones, together with tiered royalties on net sales during a specified period after the first commercial sale of the products.

2. CSTONE PHARMA-B (02616.HK): Voluntary announcement on November 4 that it entered into a clinical development collaboration with Berkeley, California-based Kimia Therapeutics to jointly advance a first-in-class candidate targeting the DNA damage response (DDR) pathway in solid tumours. CStone Pharma will apply its end-to-end oncology development and registration expertise to lead Phase I clinical trials in mainland China and Australia, comprising a dose escalation part and a dose expansion part, while Kimia will provide clinical drug supply, scientific guidance and product regulatory support. Under the agreement, Kimia will pay the clinical development costs, and CStone Pharma is entitled to milestone payments and royalties based on global net sales; no transaction amount was disclosed in the announcement.

3. DIRECT DRIVE (06731.HK): Voluntary announcement on November 3 that it entered into a three-year strategic cooperation agreement with EVERYBOT Inc. (270660.KS), a company listed on KOSDAQ in Korea, under which the two parties will carry out joint marketing, exhibition demonstrations, pilot projects and customer matching in global markets and will advance localised product adaptation for manufacturing, logistics and elderly care scenarios based on demand in the Korean domestic market and overseas markets; the company has also authorised Everybot as its distributor in the Korean market, responsible for the import, distribution, marketing, installation support and after-sales service of its robot and power module product series across online, offline, public-sector and enterprise-level channels.

Overseas Orders and Bid Wins

1. CHALCO (02600.HK): Announced on November 6 that its board approved the entry by its subsidiary Chalco Guinea, as employer, into an engineering, procurement and construction (EPC) turnkey contract with CHALIECO (02068.HK) for the alumina project in the Boffa region of the Republic of Guinea, at a fixed lump sum of approximately RMB 6.55557 billion, which is not subject to adjustment save as provided in the contract. CHALIECO is a subsidiary of Chinalco Group and a connected person of the company, and the transaction constitutes a connected transaction; the highest applicable percentage ratio may exceed 5% but be lower than 25%, and the transaction also constitutes a potentially disclosable transaction, subject to the reporting, announcement and independent shareholders' approval requirements.

Overseas Projects and Operations

1. GUOCO GROUP (00053.HK): Announced on November 4 that GLS, a wholly-owned subsidiary of its subsidiary GuocoLand, entered into a joint venture agreement with Intrepid and BDPL, a joint venture company incorporated for the project, to develop the Berlayar Drive site in Singapore in the agreed proportions of 40% for GLS and 60% for Intrepid. The site was awarded to the parties through tender by the Urban Redevelopment Authority of Singapore for SGD 576.78 million (approximately HKD 3.5368 billion), covers a site area of 25,263.2 square metres and is intended to provide up to 416 residential units; the total capital contribution of GLS is SGD 83.038 million (approximately HKD 509.19 million), comprising SGD 1.6 million of share capital and SGD 81.438 million of shareholder loans.

2. FOSUN PHARMA (02196.HK): Published an overseas regulatory announcement on November 4 that the Phase I clinical trial protocol for HLX109 injection, an IL1RAP-targeting monoclonal antibody independently developed by its controlled subsidiary Henlius for generalised pustular psoriasis, has been approved by the relevant human research ethics committee and filed with the Australian Therapeutic Goods Administration (TGA), marking the first clinical trial approval obtained for the drug worldwide; cumulative R&D investment amounted to approximately RMB 34 million as of September 2026. The announcement noted that no IL1RAP-targeting monoclonal antibody product has yet been approved for marketing globally.

Regulatory and Compliance

1. HUTCHMED (00013.HK): Announced on November 5 that sovleplenib has been granted orphan drug designation by the US FDA for the treatment of autoimmune haemolytic anaemia. FDA orphan drug designation applies to drugs for rare diseases affecting fewer than 200,000 people in the United States and confers seven years of US market exclusivity if approved for the designated indication.

2. HUTCHMED (00013.HK): Disclosed on November 2 that the marketing applications for Orpathys (savolitinib) in combination with Tagrisso (osimertinib) for the treatment of MET-driven EGFR-mutated lung cancer have been accepted in Europe and Japan, with the European Medicines Agency having confirmed and accepted the marketing authorisation application submitted by AstraZeneca and the Japanese Ministry of Health, Labour and Welfare having accepted the new drug application. The global Phase III SAFFRON study showed that the combination reduced the risk of disease progression or death by 45% versus platinum-doublet chemotherapy (PFS HR 0.55, p<0.001) and the risk of death by 32% (OS HR 0.68, p=0.010), with a median progression-free survival of 7.6 months versus 5.4 months and a median overall survival of 17.8 months versus 12.9 months.

3. ALPHAMAB-B (09966.HK): Disclosed on November 2 that the US FDA has approved its investigational new drug (IND) application for JSKN021 to conduct a Phase I clinical study, formally launching overseas clinical development of the drug. JSKN021 is an EGFR/HER3-targeting bispecific antibody dual-payload conjugate that employs glycan-based site-specific conjugation, combining a topoisomerase I inhibitor T01 at a drug-to-antibody ratio (DAR) of 4 with monomethyl auristatin E at a DAR of 2; the study was previously approved in China, with the first patient dosed in June 2026, and preliminary efficacy has been observed during dose escalation.

4. CMS (00867.HK): Its subsidiary Rxilient Medical has obtained approval from the Health Sciences Authority (HSA) of Singapore for the new drug application of ruxolitinib phosphate cream (Lumirix) for the vitiligo indication, for the treatment of non-segmental vitiligo with facial involvement in adolescents and adults aged 12 and above, making it the first and only topical prescription drug in Singapore that directly targets the pathophysiology of vitiligo. The product has been launched in Hong Kong, China, Macao, China and Taiwan, China, and was approved for marketing by China's National Medical Products Administration in January 2026.

Overseas Financing

1. SIGMASTAR (301536.SZ): Announced on November 5 that it had recently received a notice of filing for overseas issuance and listing from the China Securities Regulatory Commission (Guohehan [2026] No. 2559), proposing to issue no more than 85,583,300 ordinary shares for overseas listing and to list on the Main Board of the Stock Exchange. The company noted that the offering and listing remain subject to approval by the Securities and Futures Commission and the Stock Exchange and that, if not completed within 12 months from the date of the filing notice, updated filing materials must be submitted before proceeding.

2. ADASPACE (06935.HK): Launched its global offering on November 5 of 30.121 million H shares, comprising 3,012,100 H shares under the Hong Kong Public Offer (approximately 10%) and 27,108,900 H shares under the International Offering (approximately 90%), at an offer price range of HKD 24.90 to HKD 33.20 per share, with a board lot of 100 shares; JinkoSolar Investment Limited has subscribed HKD 5 million and Kamshin Oriental (HK) Limited HKD 55 million, totalling HKD 60 million for the two cornerstone investors, and listing on the Main Board of the Stock Exchange is expected on November 13.

3. XINDE SEMI (07672.HK): Its offering closed on November 5; as of 11:08 a.m. that day, margin financing from 10 brokers had accumulated to approximately HKD 872 million. The offer price range is HKD 8.60 to HKD 9.60 per share, with a board lot of 500 shares and an entry fee of HKD 4,848.41, and listing is expected on November 10.

4. DENGLIN (09917.HK): Its offering closed on November 5; as of 11:08 a.m. that day, margin financing had accumulated to approximately HKD 153 million. The offer price range is HKD 231 to HKD 288 per share, with a board lot of 25 shares and an entry fee of HKD 7,272.61, and listing is expected on November 10.

5. RELYEZ ENERGY (09621.HK): Its offering closed on November 4; as of 11:16 a.m. that day, margin financing from 10 brokers totalled approximately HKD 41.449 billion. The offer price ranges from HKD 8.54 to HKD 11.10 per share, with a board lot of 500 shares and an entry fee of HKD 5,605.97, and listing is expected on November 9.

6. METASURFACE (08637.HK): Announced on November 3 that the placing of new shares for its Singapore listing under a general mandate has been completed, with an aggregate of 18 million placing shares allotted and issued at SGD 0.54 (approximately HKD 3.31) per share to not fewer than 200 placees, raising net proceeds of approximately SGD 7.28 million, of which approximately 61.7% will be used for business expansion, approximately 10.3% to strengthen quality control capabilities and approximately 25.1% to pay listing expenses; the shares are expected to commence trading on the Catalist board of the Singapore Exchange on November 4.

7. HEMAY (00054.HK): Announced on November 4 that, given prevailing market conditions, it has decided to delay its global offering and listing, that the international underwriting agreement relating to the international offering will not be entered into and that the Hong Kong underwriting agreement will not become unconditional; application monies for online white form applications will be refunded in full without interest, no H share certificates have been issued and none will be delivered to any applicant, and the company stated that it remains committed to completing the global offering and listing in due course.

NewTimeSpace Going Global Observation

This week's overseas expansion story rested on two pillars. First, licensing and registration advanced in tandem on the pharmaceutical side: one bispecific antibody platform licensed an entire preclinical programme to an overseas drugmaker, two oncology drugs each made regulatory progress in the United States, Europe and Japan, and a dermatology topical obtained marketing approval in Singapore, extending overseas credentials from sales rights for individual products to platform capabilities and regional registration networks. Second, overseas financing channels opened in Hong Kong and Singapore at the same time: an A-share company obtained a filing for overseas issuance, four companies launched or closed offerings in Hong Kong, and a Hong Kong-listed company completed a Catalist placement in Singapore; at the same time, one company delayed its offering due to market conditions, showing that the window is not equally friendly to every issuer. Unlike earlier periods dominated by asset acquisitions, cross-border flows this week took place more at the level of R&D rights and the choice of listing venue, with only one heavy-asset transaction, in mining, still under regulatory review.

This article is for information purposes only and does not constitute any investment advice.