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智通港股早知道 | 11月起创新药等品种上市许可申请可享受理靠前服务 隔夜特斯拉(TSLA.US)涨近22%

Zhitong Hong Kong stocks have learned early that starting in November, the application for listing licenses for innovative drugs and other varieties can enjoy priority services. Tesla (TSLA.US) surged nearly 22% overnight.

Zhitong Finance ·  Oct 25, 2024 00:30

With the approval of the State Drug Administration, from November 1, 2024, advanced services will be provided for acceptance of marketing license applications for innovative drugs and varieties confirmed through communication that can be included in priority review and approval procedures and conditional approval procedures.

[Today's headlines]

Starting in November, you can enjoy advanced services when applying for marketing licenses for innovative drugs and other varieties

With the approval of the State Drug Administration, from November 1, 2024, advanced processing services will be provided for marketing license applications for innovative drugs and varieties confirmed through communication and confirmation that can be included in the priority review and approval procedures and conditional approval procedures. Advanced acceptance services mainly address issues such as policies, regulations, application procedures, and supporting documents relating to the acceptance of marketing license applications for innovative drugs and varieties confirmed through communication and confirmation that can be included in priority review and approval procedures, and does not include issues related to technical review.

[General outlook]

Overnight, US stocks closed with mixed ups and downs Tesla (TSLA.US) rose nearly 22%

Overnight, US stocks fell 140.59 points, or 0.33%, to 42374.36 points; the NASDAQ rose 138.83 points, or 0.76%, to 18415.49 points; and the S&P 500 rose 12.44 points, or 0.21%, to 5809.86 points. Tesla (TSLA.US) rose 21.9%, the best one-day increase since 2013/5, and its market value increased by about 150 billion dollars. IBM (IBM.US) fell more than 6%, and Nvidia (NVDA.US) rose 0.6%. Popular Chinese securities generally fell, and the Nasdaq China Golden Dragon Index fell 0.82%. Xiaopeng Motors fell more than 6%, Alibaba and Tencent Music fell more than 1%, and Zaiding Pharmaceuticals (ZLAB.US) rose 14%.

[Hot preview]

Six departments: Recycled copper and aluminum raw materials that meet the requirements are not solid waste and can be freely imported

Six departments, including the General Administration of Customs and the Ministry of Ecology and Environment, issued a notice on matters relating to regulating the import management of recycled copper and copper alloy raw materials, and recycled aluminum alloy raw materials. Among them, it is mentioned that recycled copper and aluminum raw materials that meet the requirements are not solid waste and can be freely imported. Different types of recycled copper and aluminum raw materials in the attached schedule are not allowed to be mixed, and different types of recycled copper and aluminum raw materials are not allowed to be declared under the same customs declaration at the time of customs declaration; different categories of recycled copper and aluminum raw materials are not allowed to be mixed. When different categories of recycled copper and aluminum raw materials are individually packaged, they can be mixed, but they should be sorted and placed.

Shenzhen should lead the development of “bold capital”

The “Action Plan” mentions speeding up the expansion of Shenzhen's “20+8” industrial cluster fund system, speeding up the progress of fund investment, improving the efficiency of the use of funds guided by the Shenzhen Municipal Government, supporting bold trial and error of state-owned funds, and giving full play to the leveraging role of financial resources. It is proposed that by 2026, Shenzhen should make better use of the role of government investment funds, strive to form trillion-level government investment fund groups, 100-billion-level “20+8” industrial fund groups, 10-billion-level angel parent funds, and seed fund groups; comprehensively stimulate the vitality of social capital, and strive to have more than 0.01 million registered equity investment and venture capital funds.

Hong Kong Airport Authority: It will expand the “Airport City” development blueprint by more than double the scale and is expected to be completed in 2026-2031

The Zhitong Finance App learned that the Hong Kong Airport Authority said it will more than double the size of the “Airport City” development blueprint to further promote the economic development of Hong Kong and the Guangdong-Hong Kong-Macao Greater Bay Area on the land adjacent to the airport, the artificial island at the Hong Kong-Zhuhai-Macao Bridge, and the bay between Airport Island and Tung Chung, which is the largest in the region and integrates commercial activities, pop culture, art trade, entertainment and leisure. New development projects include building an art industry ecosystem, building Asia International Expo Phase 2, setting up a yacht harbor and supporting facilities, opening a fresh air transport market, and increasing space for public events. The projects are expected to be completed from 2026 to 2031.

HSBC: China's stimulus speculation pushes emerging market fund managers to rebalance

HSBC said in a report on Thursday that all speculation surrounding China's stimulus plan has at least to some extent contributed to the rebalancing of fund managers in emerging markets. They said that global emerging market funds have now increased their holdings of mainland Chinese stocks for the first time in 10 months, and the holdings of Asian funds have also reached a five-year high. As Asian funds needed to make room for mainland China, South Korea and India were affected, while the situation in Southeast Asia was better. Global emerging market funds have also reduced their weight on Latin America. Over the past month, Chinese policymakers announced a series of stimulus measures, which boosted market interest, but also left investors awaiting specific details.

Sinotrans (00598): Obtained a loan of 0.379 billion yuan to repurchase shares

Sinotrans announced that the company plans to repurchase shares through centralized bidding transactions through the Shanghai Stock Exchange trading system. It has signed a “Cooperation Agreement” with Bank of China Co., Ltd. Beijing Branch and obtained a “Loan Commitment Letter” issued by it. The Beijing branch of the Bank of China will provide a loan amount of no more than RMB 0.379 billion for the company's A-share repurchase project. In principle, the loan interest rate will not exceed 2.25% and the market interest rate.

The amount of new contracts signed by China Communications Construction (01800) in the first three quarters was 1.28 trillion yuan, up 9.28% year-on-year

Zhitong Finance App News, China Communications Construction issued an announcement. In 2024, the company will continue to focus on its main business in market development, make every effort to promote the “internationalization and upgrading of the company” and accelerate the development of new quality productivity. In the first three quarters, the Group signed a new contract amount of RMB 1.28 trillion yuan, an increase of 9.28% over the previous year, and achieved 64% of the annual target (estimated increase of 13.5% on the basis of the new contract amount of RMB 1.75 trillion yuan in 2023 as reviewed and approved by the company's board of directors) . Among them, infrastructure construction business, infrastructure design business, dredging business, and other businesses were RMB 1.15 trillion, RMB 38.716 billion, RMB 84.209 billion, and RMB 8.081 billion, respectively. The Group accelerated the construction of an emerging business pattern, increased efforts to develop emerging business markets, and actively built new quality productivity unique to CCCC. In the first three quarters, new contracts were signed in the emerging business sector of RMB 390 billion, an increase of 27% over the previous year.

Tiangong International (00826): Tiangong Co., Ltd.'s net profit to mother in the first three quarters was about 0.142 billion yuan, up 10.54% year-on-year

According to the Zhitong Finance App, Tiangong International announced the results of Tiangong Co., Ltd. for the first nine months of 2024, with revenue of about 0.6 billion yuan and net profit to mother of about 0.142 billion yuan, an increase of 10.54% over the previous year; basic earnings per share were 0.241 yuan.

Tianqi Lithium (09696) is forecasting a net loss of 5.45 billion to 5.85 billion yuan for the first three quarters

Zhitong Finance App News, Tianqi Lithium issued an announcement. The net loss range attributable to the Group's shareholders for the nine months ending September 30, 2024 is expected to be RMB 5.45 billion to RMB 5.85 billion (unaudited), while the net profit attributable to the company's shareholders during the same period last year was RMB 8.0985 billion; the net loss range after deducting non-recurring profit and loss is estimated to be RMB 5.47 billion to 5.87 billion yuan (unaudited), and above The Group's net profit after deducting non-recurring profit and loss for the same period of the year was RMB 7.982 billion; and the basic loss range per share is estimated to be RMB 3.32 to RMB 3.57 (same period last year: basic profit per share was RMB 4.93).

Jinli Permanent Magnet (06680) announced third-quarter results, net profit of about 77.2065 million yuan, a year-on-year decrease of 52.24%

According to the Zhitong Finance App, Jinli Permanent Magnet announced its results for the third quarter of 2024, with operating income of about 1.653 billion yuan, up 1.99% year on year; net profit attributable to shareholders of listed companies was about 77.2065 million yuan, a year-on-year decrease of 52.24%; basic earnings per share were 0.06 yuan.

[Individual stocks cleared]

Heyu-B (02256): Facing the core pipeline to reveal the ignorance of phase III clinical trials

As a biotech with a small Hong Kong stock market capitalization, Heyi currently has a lot of bonus points: stable BD with MNC, potential best in class pipelines to be commercialized, and plenty of imagination for subsequent pipelines. If ABSK021 clinical phase III blindness detection is successful, it will greatly brighten its prospects.

Yesterday, the company announced that at the 36th International Conference on Molecular Targets and Cancer Therapy (EORTC-NCI-AACR Conference), it showcased two important pre-clinical research results. The two studies involved ABSK131, a potentially best-in-class PRMT5*MTA inhibitor, and ABSK141, an oral KRASG12D small molecule inhibitor, respectively.

The ABSK131 study showed that the inhibitor has better activity and selectivity, and can effectively penetrate the blood-brain barrier. It is suitable for cancer patients with missing MTAP genes, which indicates its potential in preclinical development. At the same time, ABSK141 showed high binding ability to the KRASG12D mutation, good biochemical activity, and strong anti-proliferative ability in vitro experiments, supporting its rapid preclinical development.

In December of last year, Heyu reached a BD agreement with Merck, granting it exclusive commercialization rights for ABSK021 in Greater China. The R&D and commercialization milestone payments reached $0.6055 billion, in addition to a sales share of more than 10%. In the case of Merck's commercialization channel, it would reduce the cost by a considerable amount of money and much less risky than setting up a commercial team with Hewlett's own, which is a relatively stable choice.

Disclaimer: This content is for informational and educational purposes only and does not constitute a recommendation or endorsement of any specific investment or investment strategy. Read more
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