The Hong Kong Biotech Index is -23A 98% full-year decline ended in 2023. The index has been running for 5 years since 2019 and has fallen for 3 consecutive years. And from the perspective of year k, it is a shrinkage....
1.Exist in name only.
2.A new low.
3.Overview.
4.Commercialization.
5.Results meeting.
6.IND administration.
7. bd8.Personnel
9.Epilogue.
Since its operation in 2018, a total of 63 companies have passed this rule in Hong Kong IPOs since its operation in 2018.
Under the bleak baptism of 2022 and 2023 for two consecutive years, the amount of IPO fundraising and the number of IPOs both fell to the freezing point, with the annual fundraising amount of about HK $35 billion during the bull market and about HK $3.5 billion during the bear market, a difference of about 10 times, in other words, a drop of 90%.
Figure 1 IPO situation of Hong Kong stock 18A over the years (compiled by Fengshuo Venture Capital).
In the past two years, there was first an "IPO assassin", and then "IPO is lonely". "IPO assassins" refer to those companies that broke the issue on the same day, and "IPO is lonely" refers to those companies whose IPO fundraising amount is far from the market value of the issue.
The more money is lacking in the market, the more "lonely IPOs" appear, especially in 2022. The issuance market value from 2018 to 2021 The proportion of IPO financing is generally about 5-10 times, and the median value in 2022 and 2023 has risen to about 20 times, and the proportion of several companies in 2022 has reached 50 times, which means that the issue market value of 10 billion will only raise 200 million Hong Kong dollars, which is not worth mentioning.
Figure 2 The market value of Hong Kong stock 18A over the years and the proportion of IPO proceeds (sorted out by Fruitful Venture Capital).
The 18A IPO channel of Hong Kong stocks, which has lost its financing ability, has existed in name only.
2 The companies discussed below are 30 18A innovative drug companies that have been on the Hong Kong Stock Connect list in 2023 and before, an increase of 4 from 2022.
In 2022, please see "China's Innovative Drugs Enter the Post-Epidemic Year", and in 2021, please see "The Past of the Year of the Ox, China's Innovative Drugs Have No Tears".
Of the 30 companies in 2023, 5 have a positive annual increase, which is 2761%, Genting Xinyao's 2025%, Yongtai Bio's 823%, 791% and Ascentage Pharma's 623%, 3 more than in 2022.
The largest increase in a single quarter was 6918%, the largest decline in a single quarter was 85 in Q385%。
Figure 3 The rise and fall of stock prices in 2023 (compiled by Fengshuo Venture Capital).
As of the end of 2023, in 2023, 17 companies have achieved new lows in post-IPO stock prices (excluding IPOs in 2023) including Boan Biopharma, Jacobio, Ocumension Biologics, Sirnaomics, Lepu Biopharma, JW Therapeutics, InnoCare, CStone Pharmaceuticals, Genor Biopharma, CARsgen, Junshi Biosciences, Antengene, CanSino Biologics, Brii Biosciences, Clover, Idea Di, and Kintor Pharmaceuticals, a total of 17 companies.
3. Overview information** from press releases and announcements on the official websites of each company.
In terms of clinical trial promotion, a total of 152 events were disclosed, a decrease of 21% year-on-year. In terms of results announcement, a total of 304 incidents were disclosed, a decrease of 3% year-on-year. In terms of drug marketing applications, a total of 72 events were disclosed, a decrease of 21% year-on-year.
Figure 4 The operation of 18A Hong Kong Stock Connect Biotech in 2023 (compiled by Fengshuo Venture Capital).
Behind these figures, these measures such as cost reduction and efficiency increase, layoffs and salary reductions, and company optimization are reflected in 2023.
4 No matter how bad the commercialization is, eating when you are hungry and taking medicine when you are sick will not change, the following chapters will introduce the pioneering work made by these target companies in the cold winter, and the content is a bit much, you can skip directly to the end of the article to see the conclusion.
The first milestone is highlighted below.
BeiGene. On January 19, 2023, MHRA approved BRUKINSA (zanubrutinib) in Great Britain for marginal zone lymphoma (MZL). It is currently the only drug approved for MZL** in Great Britain.
Innovent Biologics. On May 9, 2023, the NMPA approved Tyvyt in combination with bevacizumab and chemotherapy for patients with EGFR-positive non-squamous non-small cell lung cancer who have failed EGFR-TKI**. The world's first PD-1 inhibitor approved for EGFR-positive non-squamous non-small cell lung cancer (NSCLC) with EGFR-TKI** failure.
On July 3, 2023, the NMPA approved the New Drug Application (NDA) for the treatment of patients with refractory multiple myeloma** who have progressed on at least 3 prior lines (at least one proteasome inhibitor and immunomodulator). It is the first BCMA CAR-T product to be marketed in China, the world's first commercialized fully human CAR-T product, and the first CAR-T cell independently developed and produced in the whole process in China**.
On August 16, 2023, the NMPA approved the PCSK9 inhibitor Symbila for the treatment of patients with primary hypercholesterolemia and mixed dyslipidemia. China's first approved locally developed PCSK9 inhibitor.
On November 24, 2023, the NMPA accepted IBI351 for patients with advanced non-small cell lung cancer (NSCLC) with at least one systemic KRAS G12C mutation. The first KRAS G12C inhibitor to be submitted to NDA in China.
Junshi Biosciences. On April 11, 2023, the NMPA accepted the New Indication Application for toripalimab for the perioperative period** of patients with operable non-small cell lung cancer. The world's first Phase III registration study to demonstrate that an anti-PD-1 monoclonal antibody can significantly prolong EFS in patients with operable non-small cell lung cancer**.
On July 11, 2023, the NMPA accepted the New Indication Application for toripalimab for the first-line** treatment of advanced renal cell carcinoma. The field of kidney cancer in China is expected to usher in the first "immunity + targeting" combination**.
On July 19, 2023, the NMPA accepted the New Drug Application (NDA) for toripalimab for the first-line** treatment of extensive-stage small cell lung cancer. The world's first PD-1 inhibitor to achieve the dual primary endpoints of overall survival (OS) and progression-free survival (PFS) in the first-line**Phase III study of ES-SCLC.
On October 29, 2023, the FDA approved toripalimab for the full spectrum of metastatic nasopharyngeal carcinoma. The first and only drug approved in the U.S. for nasopharyngeal carcinoma**; The first innovative biologics independently developed and manufactured in China approved by the FDA.
CStone Pharmaceuticals. On February 28, 2023, the NMPA accepted the marketing application for Cejemix (sugemalimab injection) for the new indication of first-line** locally advanced or metastatic gastroesophageal junction adenocarcinoma. It is expected to be the world's first PD-L1 monoclonal antibody approved for adenocarcinoma of the gastroesophageal junction.
On April 6, 2023, the NMPA accepted the marketing application for the new indication of Cejemix (sugemalimab injection) for first-line** esophageal squamous cell carcinoma. It is expected to be the world's first PD-L1 monoclonal antibody for unresectable locally advanced, ** or metastatic esophageal squamous cell carcinoma.
On October 31, 2023, the NMPA approved Cejemix (sugemalimab injection)** for refractory extranodal NK T-cell lymphoma. The world's first immuno-oncology drug approved for the indication of ** or refractory extranodal NK T-cell lymphoma (R r ENKTL).
On December 8, 2023, the NMPA approved Cejemix (sugemalimab injection) for the new indication of first-line** esophageal squamous cell carcinoma. The world's first PD-L1 monoclonal antibody approved in combination with fluorouracil and platinum-based chemotherapy drugs for the first-line indication of unresectable locally advanced, ** or metastatic esophageal squamous cell carcinoma.
InnoCare. On April 20, 2023, the NMPA approved orelabrutinib for patients with refractory marginal zone lymphoma (MZL). The first and only BTK inhibitor approved for marginal zone lymphoma in China.
Akeso. On August 24, 2023, the NMPA accepted the New Drug Authorization Application for Evonicimab for the treatment of **moderate to severe plaque psoriasis. The first domestic new drug IL-12 IL-23 monoclonal antibody was reported for production.
Zai Lab. On June 30, 2023, the NMPA approved the approval of Weigatm (agamod injection) for marketing in China for generalized myasthenia gravis**. The first and only FCRN antagonist approved by the National Medical Products Administration (NMPA) in China for patients with generalized myasthenia gravis (GMG)**.
Clover creatures.
On September 12, 2023, the quadrivalent seasonal influenza vaccine was launched in Chinese mainland. At present, it is the only imported quadrivalent seasonal influenza vaccine approved for people aged three years and above.
Kedi Group. On September 27, 2023, the NDA for CU-10201 (topical 4% minocycline foam) was accepted by the National Medical Products Administration. The first topical minocycline to be accepted by the NMPA.
Figure 5 Commercialization of 18A Hong Kong Stock Connect Biotech in 2023 (compiled by Fengshuo Venture Capital).
5. The results of the meeting will focus on the first milestone event below.
Innovent Biologics. March 21, 2023, AACR 2023, Poster: Results of a multicenter randomized controlled phase III clinical study (ORIENT-16) of sintilimab injection in combination with chemotherapy in first-line ** gastric or gastroesophageal junction adenocarcinoma. The first randomized controlled phase III clinical study based on the Chinese population to prove that PD-1 monoclonal antibody combined with chemotherapy can significantly prolong the overall survival of patients with locally advanced and metastatic gastric cancer.
Junshi Biosciences. January 3, 2023, Press Release Comparing Paxlovid to Paxlovid in Early** Patients With Mild to Moderate COVID-19 Patients With Severe Progression and Risk Factors for Death. The first "head-to-head" phase III clinical study of a small molecule oral antiviral drug in COVID-19 patients in China during the Omicron variant epidemic.
On January 18, 2023, it was press released that the Phase III study of toripalimab in combination with chemotherapy in patients with operable non-small cell lung cancer** met its primary endpoint. The world's first Phase III registration study of perioperative immunology** for lung cancer with a positive EFS result.
Feb. 20, 2023 – Press Release Presenting Toripalimab in Combination With Chemotherapy** Phase III Clinical Study in Advanced Triple-Negative Breast Cancer Meets Primary Endpoint. The first phase III registration study in China to achieve positive results in the field of advanced TNBC immunity**.
April 21, 2023, ASCO PLENARY SERIES, ORAL: Toripalimab in combination with chemotherapy in the perioperative** phase III clinical study of operable non-small cell lung cancer (NSCLC) (NeoTorch). The world's first Phase III clinical study of an anti-PD-1 monoclonal antibody in the perioperative period** of non-small cell lung cancer (NSCLC) that met the primary endpoint.
April 26, 2023 (PRESS RELEASE) -- The Phase III clinical study of toripalimab in first-line advanced renal cell carcinoma (RCC**) met the primary endpoint and significantly prolonged progression-free survival. The first phase III study of advanced kidney cancer immunity in China.
June 7, 2023, ASCO 2023, NeoTorch, the world's first PD-1 inhibitor perioperative** non-small cell lung cancer study to report positive event-free survival (EFS) results.
On September 25, 2023, it was press release that the first-line** melanoma phase study of toripalimab met its primary endpoint. The first PD-(L)1 inhibitor first-line** advanced melanoma clinical study in China to achieve positive results.
October 20, 2023, ESMO 2023, Oral: The world's first Phase 1 study of PCLC PD-1 immunization achieves "double positive" results. The world's first PD-1 inhibitor to achieve the dual primary endpoints of OS and PFS in the first-line Phase ** study of ES-SCLC.
Akeso. October 13, 2023, EADV 2023, results of a randomized, double-blind, placebo-parallel-controlled, multicenter phase III clinical study of erokimab (AK101)**, a fully human monoclonal antibody targeting IL-12 IL-23, in moderate to severe plaque psoriasis. The first new antibody-like drug targeting IL-12 and IL-23 targets in China.
On November 23, 2023, it was reported that the first-line first-line** phase III study of cadonilib cervical cancer met the primary endpoint of PFS, and the benefit advantage of the whole population continued to be significant. The world's first PD-1 CTLA-4 bispecific antibody in combination with platinum-containing chemotherapy + bevacizumab in first-line persistent, ** or metastatic cervical cancer.
Figure 6 The results of the 18A Hong Kong Stock Connect Biotech trial in 2023 (compiled by Fengshuo Venture Capital).
6IND dosing: The first milestone event is described below.
Innovent Biologics. On February 16, 2023, the first patient was dosed in the Phase III clinical study (CLEAR) of Picankibart (anti-IL23P19 antibody)** in moderate to severe plaque psoriasis. At present, it is the first phase III clinical study of an innovative IL-23 target drug in China.
Junshi Biosciences. On June 28, 2023, the FDA approved Junshi Biosciences to conduct a Phase III clinical study of tifcemalimab (anti-BTLA) in combination with toripalimab** in patients with limited-stage small cell lung cancer. The first confirmatory study of a BTLA target drug.
Ascentage Pharma. On July 6, 2023, the first-line **PH+ ALL pivotal registrational phase study of Naelik was approved by CDE for clinical trial. It is expected to become the first tyrosine kinase inhibitor (TKI) drug for first-line **pH+ ALL in China.
On August 7, 2023, the U.S. FDA approved the global registrational Phase III clinical study of Ascentage Therapeutics' BCL-2 inhibitor APG-2575** in patients with CLL SLL. It is expected to accelerate to become the second BCL-2 inhibitor approved for marketing at the global level.
Akeso. On March 14, 2023, the pivotal phase III registration clinical study of ketani in combination with chemotherapy in first-line** unresectable locally advanced or metastatic gastric adenocarcinoma or gastroesophageal junction adenocarcinoma (GC GEJC) has completed the enrollment of subjects. The world's first clinical study of PD-1 CTLA-4 bispecific antibody combined with chemotherapy for first-line** gastric cancer.
Pioneer Pharmaceutical. On April 14, 2023, the first patient was enrolled in the Phase II clinical trial of AR-PROTAC (GT20029)** alopecia in China. The world's first topical PROTAC compound to enter Phase II clinical trials.
Ocumension. On February 1, 2023, the Phase III clinical trial of OT-101 completed the enrollment of subjects in China. The world's first phase II international multi-center clinical trial of low-concentration atropine and its analogues, including the Chinese population.
Antengene. On May 18, 2023, the FDA approved the clinical trial of ATG-031. The world's first anti-CD24 monoclonal antibody to enter clinical development in the field of oncology**.
Harbour BioMed. On January 12, 2023, the world's first antibody targeting B7H7 was approved for clinical trial in the United States. The world's first monoclonal antibody targeting B7H7 that has been officially approved to enter the clinical stage.
On June 5, 2023, the world's first Phase I clinical trial of HBM1020, a first-in-class antibody targeting B7H7 HHLA2, was dosed to the first patient in the United States. The world's first monoclonal antibody targeting B7H7 HHLA2 to be officially approved for clinical development.
Jacobio. On July 4, 2023, the pivotal clinical trial of Grerecel inhibitor for pancreatic cancer was approved by the CDE. The world's first homogeneous target project approved to carry out pivotal clinical studies in pancreatic cancer.
Clover creatures.
On December 13, 2023, the Phase 1 clinical trial of the RSV vaccine candidate was initiated. The first RSV Pref (pre-fusion conformation-based F protein) vaccine candidate developed in China has entered clinical trials.
Boan Biotech. On February 13, 2023, the first patient of the Phase I clinical trial of CD25 innovative antibody BA1106 was dosed. The first CD25 innovative antibody for solid tumors in China that has entered the clinical stage.
On February 14, 2023, the first patient of the Phase I clinical trial was dosed with BA2101, an innovative anti-IL-4R innovative long-acting monoclonal antibody. The first anti-IL-4R long-acting new drug in China to enter the clinical stage.
On August 29, 2023, the first CEA CD3 innovative bispecific antibody in China! Boan Biotech BA1202 completed the dosing of the first subject. The first CEA CD3 bispecific antibody product to enter the clinical stage in China.
On October 30, 2023, the first patient was enrolled in the phase III clinical trial of nivolumab injection. The first phase III clinical trial of opdivo biosimilar in China.
Figure 7 IND dosing of 18A Hong Kong Stock Connect Biotech in 2023 (compiled by Fengshuo Venture Capital).
7BD Among the batch of companies in 2023, the largest down payment for license out is the transfer of the global rights and interests of CMG901 to AstraZeneca by Kangnuoya Lepu Biotech, with an advance payment of 0$6.3 billion, more than $1.1 billion in potential R&D and sales-related milestone payments.
It was also a year of "regain" of many products, such as BeiGene's acquisition of the TIGIT inhibitor ociperlimab and the PD-1 inhibitor tislelizumab from Novartis, and the recapture of the SHP2 inhibitor by Jacobio from AbbVie.
Figure 8 BD situation of 18A Hong Kong Stock Connect Biotech in 2023 (compiled by Fengshuo Venture Capital).
8. Enterprises with changes in personnel and core technical personnel include Junshi Biosciences.
The companies with CFO changes include CanSino, InnoCare, Akeso, Kintor Pharmaceutical, Zai Lab, JW Therapeutics, and Remegen.
The change of chief commercial officer is Ascentage Pharma.
President The global oncology R&D leader has changed its company, including Zai Lab.
Companies with COO changes include Genting Xinyao.
Companies with CTO changes include Genting Xinyao.
The change in senior vice president of preclinical and clinical development is Sirnaomics.
Companies with a change in chief medical officer include Sirnaomics.
Figure 9 Personnel changes in 18A Hong Kong Stock Connect Biotech in 2023 (compiled by Fengshuo Venture Capital).
Conclusion 2023 is a year in which China's pharmaceutical industry has set many records, and these honors are mainly concentrated in the "old money" in China's pharmaceutical industry and the "new money" enterprises in the primary market. In stark contrast, this group of Hong Kong Stock Connect 18A innovative drug companies that emerged in the early stage in the middle continue to set new low stock price records. Hot IPOs don't happen often, and hot license outs don't happen often. After the great heat, there will be a great cold, and after the great cold, there will be a sunny spring. Only medicine is with the sun and the moon. Disclaimer: The above content is for informational purposes only and does not constitute investment advice.
Fruitful Ventures. Founded in 2019, Fengshuo Venture Capital focuses on investment in the field of big health. Fengshuo Venture Capital is a venture capital based on fundamental research, focusing on the exploration of the company's long-term development value. Through multi-dimensional cognition and continuous self-evolution, we build a complete investment system. We have trustee genes, have a sense of awe for the capital market, put risk control in the first place, and continue to create value for investors with a sniper style and professional vision.