Going Global Weekly: Pharmaceutical Compliance Qualifications and Overseas Orders Land Densely, Hong Kong Fundraising and Offshore Bond Issuance Accelerate in Tandem-20261016

LEADS BIOLABS-B's LBL-024 received FDA Fast Track Designation, HANSOH PHARMA's EU Marketing Authorisation Application for aumolertinib was accepted by the EMA, and WASION HOLDINGS' AMI meters passed U.S. ANSI certification and secured smart grid orders worth approximately RMB 1.25 billion in the Middle East. On the financing side, TRANSSION listed its H shares at HKD 35.30 per share, SWL TOUR launched its global offering, and TENCENT completed the pricing of USD 1.8 billion and RMB 26 billion of notes.

Overseas Cooperation

1. ALCO HOLDINGS (00328.HK): Announced on October 13 that the company has entered into long-term cooperation agreements with distributors located in Brazil and Chile respectively, covering the distribution and sale of the group's laptops and tablets in the relevant markets and the promotion of the company's own brands in South America. The board believes the agreements will help open up the South American market and further diversify its geographical market coverage, while the actual contribution will depend on market demand, distributor performance and the execution of the distribution arrangements.

Overseas Orders and Bid Wins

1. TIANGONG INT'L (00826.HK): In a voluntary announcement on October 15, its indirectly wholly-owned subsidiary Five Star Special Steel Europe S.R.L. entered into a procurement agreement with an existing European end customer to supply mould steel products of various specifications, with a supply schedule of 5,000 tonnes by May 2027, worth approximately RMB 80 million. The company said the agreement will help provide a stable export revenue stream for its mould steel segment, and that the customer and its ultimate beneficial owners are independent of the company and its connected persons.

2. WASION HOLDINGS (03393.HK): Announced on October 12 that the group recently secured several orders for smart grid-related products and solutions in emerging markets in the Middle East, with a total contract value of approximately RMB 1.25 billion (approximately HKD 1.47 billion), mainly covering metering products such as smart meters and services, expected to be delivered and recognized as revenue in phases within three years, with the customers being local power utilities of scale and good credit standing.

Overseas Projects and Operations

1. CHINA MER PORT (00144.HK): Announced on October 15 that FCGL, Access Engineering, SLPA and SACL entered into a settlement agreement to terminate the shareholders' agreement, the BOT agreement and the site lease agreement early and in an orderly manner with effect from the date of the agreement, so as to resolve all matters relating to the South Asia Commercial and Logistics Hub (SACLH) project. The shareholders of SACL had previously injected a total of USD 37.14 million in equity into the project, of which FCGL contributed USD 26 million; SLPA will pay SACL a one-off sum of USD 21.905 million within 30 days, which, together with approximately USD 7.85 million of distributable cash available at SACL, will be distributed to the three shareholders in the proportions of 70%, 15% and 15%, with FCGL receiving approximately USD 20.83 million in total.

Overseas Operating Data

1. GENSCRIPT BIO (01548.HK): Announced on October 13 that its associate Legend Biotech has filed a Form 6-K with the U.S. Securities and Exchange Commission, disclosing that CARVYKTI(R) generated net trade sales of approximately USD 710 million for the quarter ended September 30, 2026. The announcement noted that the figure is based on information provided by Janssen to Legend Biotech, and that neither Legend Biotech nor the company has independently verified its accuracy.

Regulatory and Compliance

1. LEADS BIOLABS-B (09887.HK): Announced on October 12 that its core product LBL-024 (Opamtistomig, a PD-L1/4-1BB bispecific antibody) has been granted Fast Track Designation by the U.S. FDA for the first-line treatment of advanced biliary tract cancer (BTC), taking only nine days from submission to approval. This is the second Fast Track Designation for LBL-024, following extrapulmonary neuroendocrine carcinoma, and the FDA also recommended that the company communicate as soon as possible on the registration plan for LBL-024 in combination with chemotherapy in BTC.

2. HANSOH PHARMA (03692.HK): Announced on October 11 that the company resubmitted the EU Marketing Authorisation Application for its innovative drug aumolertinib (overseas brand name Aumseqa(R)) to the European Medicines Agency on September 29, and the EMA confirmed acceptance on October 7 and initiated the centralized approval procedure. The indications in this application include first-line treatment of advanced non-small cell lung cancer with EGFR exon 19 deletion or exon 21 (L858R) substitution mutations, as well as treatment of EGFR T790M mutation-positive advanced NSCLC.

3. WASION HOLDINGS (03393.HK): Announced on October 12 that the AMI meter products of its wholly-owned subsidiary Wasion Americas Inc. have formally passed certification by the American National Standards Institute (ANSI). The ANSI C12 series standards are the access specifications used by U.S. power utilities for revenue-settlement meters, and the company said the certification helps lay a qualification foundation for the group to expand into the North American power market.

4. STD DEV GROUP (01867.HK): In a voluntary announcement on October 13, its subsidiary Standard Development (Shandong) passed an independent audit under the ISCC framework by certification body RINA Services S.p.A. and was awarded ISCC EU and ISCC PLUS certifications, confirming its compliance with the sustainability requirements and greenhouse gas emission reduction standards defined by the European Renewable Energy Directive, covering the technical compliance pathway for converting carbon-based waste such as waste tyres into low-carbon marine fuel oil, low-carbon diesel and sustainable aviation fuel.

Overseas Financing

1. TENCENT (00700.HK): Announced on October 13 (New York time) the pricing of U.S. dollar notes with an aggregate principal amount of USD 1.8 billion and RMB notes with an aggregate principal amount of RMB 26 billion under its Global Medium Term Note Programme, with estimated net proceeds, after deducting underwriting fees, discounts and commissions, of approximately USD 1.79 billion and RMB 25.89 billion respectively, intended for general corporate purposes; the notes are expected to be issued on October 21 and intended to be listed on the Stock Exchange. Among them, the October 2036 U.S. dollar notes total USD 1.30 billion with a coupon rate of 6.10%, and the October 2046 U.S. dollar notes total USD 500 million with a coupon rate of 6.75%.

2. TRANSSION (02636.HK): Its H shares were listed on the Main Board of the Hong Kong Stock Exchange at 9:00 a.m. on October 15 at a final offer price of HKD 35.30 per share; the global offering comprised 86,648,300 H shares, of which 8,664,900 H shares were offered in the Hong Kong public offering and 77,983,400 H shares in the international offering.

3. SWL TOUR (06157.HK): Published its prospectus on October 14 for a global offering of 44,760,000 H shares, of which 4,476,000 H shares (10%) were offered in the Hong Kong public offering and 40,284,000 H shares (90%) in the international offering, at an offer price of no more than HKD 5.07 per share and expected to be no less than HKD 3.92 per share, with listing expected on October 23.

NewTimeSpace Going Global Observation

This week's overseas expansion theme was built on two threads. First, overseas compliance qualifications and orders landed densely: LEADS BIOLABS-B's core product received FDA Fast Track Designation and HANSOH PHARMA's resubmitted EU Marketing Authorisation Application for aumolertinib was accepted by the EMA, while WASION HOLDINGS' AMI meters passed U.S. ANSI certification and STD DEV GROUP obtained ISCC EU and ISCC PLUS certifications issued by RINA; running in parallel were the signing of overseas orders, with WASION HOLDINGS securing smart grid orders in the Middle East and TIANGONG INT'L entering into a mould steel supply agreement with a European end customer. Second, offshore financing channels opened up in tandem: TRANSSION listed its H shares and SWL TOUR launched its global offering, while offshore bonds and overseas note financing also advanced, with TENCENT completing the pricing of U.S. dollar and RMB notes. Unlike the earlier phase, when overseas expansion was mainly conducted through equity acquisitions, this week's transactions were more concentrated on execution links such as qualification access, order acquisition and funding-side arrangements, with the overseas expansion path shifting from asset acquisitions to market access and financing advancing in parallel.

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

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