On 11 September 2026, PEIJIA-B (09996.HK) announced that the Company's internally developed GeminiOne® Transcatheter Edge-to-Edge Repair (TEER) System has recently received approval from the National Medical Products Administration of the People's Republic of China for its registration application; the Company said the approval marks the Group's entry into the commercial treatment of mitral regurgitation.
On 11 September 2026, HENGRUI PHARMA (01276.HK) announced that Ruzaltatug Rezetecan for Injection (SHR-A2009 for Injection) of its subsidiary Suzhou Suncadia Biopharmaceuticals Co., Ltd. has been included in the breakthrough therapy designation list by the Center for Drug Evaluation of the National Medical Products Administration, for use in combination with bevacizumab in patients with EGFR-mutated locally advanced or metastatic non-squamous NSCLC who have failed prior EGFR TKI treatment.
On 11 September 2026, FOSUN PHARMA (02196.HK) announced that the NMPA has accepted the drug registration application for the 120mg (1.7ml) vial specification of HLX14, a recombinant anti-RANKL fully human monoclonal antibody injection developed by its subsidiary Henlius as a denosumab biosimilar, covering all indications of the reference product Xgeva approved in mainland China; HLX14 (60mg/mL and 120mg/1.7mL) is already approved in the US, EU, UK and Canada, the group's cumulative R&D investment reached approximately RMB 352 million as at August 2026, and global denosumab sales were approximately USD 8.092 billion in 2025.
On September 11, 2026, the three major Hong Kong stock indices opened lower and moved in a choppy range, with the Hang Seng Index down 0.60%, the Hang Seng Tech Index down 0.23%, and the Hang Seng China Enterprises Index down 0.34%.Most Hong Kong stock AI concept stocks weakened, with the LLM and Autonomous Driving sectors continuing to face pressure and AI Chips declining across the board.
On 11 September 2026, HANSOH PHARMA (03692.HK) announced that Ruikang Lifutuota Monoclonal Antibody for injection (HS-20093) has been included in the NMPA priority review and approval procedure for small cell lung cancer that has failed platinum-containing treatment, based on positive results from the pivotal Phase III trial ARTEMIS-008, with the inclusion dated 21 August 2026.
On September 11, 2026, RoboSense (02498.HK) traded weaker in the afternoon session. As of 13:56, its intraday quotation stood at HK$16.83, down 1.81%.
on September 11, 2026, the AI chip theme saw a volatile pullback, with SMIC (00981.HK) weakening. As of 13:46, the company was quoted at HK$62.950, down 0.79%.
on September 11, 2026, the humanoid robot theme saw a volatile pullback, with UBTECH ROBOTICS (09880.HK) weakening. As of 13:35, the company was quoted at HK$77.200, down 4.22%.
On 11 September 2026, OCUMENSION-B (01477.HK) announced that the NDA for OT-301 (NCX 470, latanoprostene bunod) to lower IOP in open-angle glaucoma or ocular hypertension patients has been accepted by the NMPA's Center for Drug Evaluation.
On 10 September 2026, HENGRUI PHARMA (01276.HK) announced that the NMPA approved two additional indications for Hetrombopag Olamine Tablets, a Class 1 innovative drug, for adult patients with chemotherapy-induced thrombocytopenia (CTIT) and paediatric patients aged 6 and above with chronic primary immune thrombocytopenia (ITP), classified as a Category 2.4 chemical drug; the product becomes the world's first TPO-RA approved for CTIT, with cumulative R&D investment of approximately RMB 657.70 million (unaudited).
On September 10, 2026, the three major Hong Kong indices continued to weaken, with the Hang Seng Index down 1.27%, the Hang Seng TECH Index down 2.04%, and the Hang Seng China Enterprises Index down 1.13%. AI concept stocks were generally under pressure on the day, with the large model sector declining across the board, AI chips showing mixed gains and losses, and the intelligent driving and embodied intelligence sectors mostly following the decline.
On September 10, 2026, XPENG-W (09868.HK) traded weaker in the afternoon session. As of 14:01, it was quoted at HK$40.80, down 3.55%.
on September 10, 2026, the chip theme traded with volatility, with HUA HONG GRACE (01347.HK) moving higher. As of 13:55, the company was quoted at HK$113.900, up 2.06%.
on September 10, 2026, the robotics theme fluctuated and weakened, with MIDEA GROUP (00300.HK) bucking the trend to move higher. As of 13:34, the company was quoted at HK$99.150, up 0.51%.
On 10 September 2026, SSY GROUP (02005.HK) announced that it obtained the drug production registration approval from the National Medical Products Administration for Letermovir Injection (12ml: 240mg), a Category 4 chemical drug deemed to have passed the consistency evaluation, indicated for prophylaxis of cytomegalovirus infection and disease in CMV-seropositive adult recipients of allogeneic hematopoietic stem cell transplants; the approval further enriches the Group's perioperative product portfolio.
On 10 September 2026, INSILICO (03696.HK) announced that its AI-driven candidate Rentosertib completed first patient dosing in the Phase III IPF trial GENESIS-IPF-3 at Peking Union Medical College Hospital and Shanghai Pulmonary Hospital on the same day. The 52-week study plans to enroll 320 subjects at 47 Chinese centers with annual FVC decline rate as primary endpoint, led by Professor Xu Zuojun, with Academician Zhong Nanshan and Chen Chang as co-lead investigators.
