中國生技製藥產業的 Next Decade？

In Healthcare By Sigrid On

中國生技製藥產業在過去十年，從監管改革到技術研發，如細胞基因療法、mRNA 疫苗及 AI 輔助藥物發現，逐步成為全球領先國家之一。然而，地緣政治挑戰與政策不確定性可能影響其未來發展，美國《生物安全法案》對中美合作構成威脅，但也為中國提升內需市場創造契機。台灣企業可從中汲取經驗，在國際競爭中找到定位並探索合作機會，共同迎接全球生技產業的快速變遷。

中國生技製藥產業的 Next Decade？

今年（2024）生技產業的地緣政治情勢有點變化，一場涉及中國藥品委託開發暨製造服務（Contract Development and Manufacturing Organization，CDMO）藥明康德（Wuxi AppTec）的爭議，讓美國政府提出了《生物安全法案》（BIOSECURE Act）。簡單來說，藥明康德被指控將美國公司的機密資料分享給中國政府，《生物安全法案》的目的是要遏止美國生技公司與中國的 CDMO 合作。

如果我們從更宏觀的角度來看，中國的生技產業不是只有 CDMO，即使《生物安全法案》通過，中國在生技產業中的角色也不會就此終結。科睿唯安（Clarivate Analytics）最近發布一份報告 — — 「中國創新十年（A decade of innovation in China）」，分析過去十年中，在有目的性的政策推動和日益全球化的狀況下，中國生技產業的發展情形：中國已經成為全球生物製藥生態系的一大強國，從加速藥品審批的監管改革，到細胞、基因療法等尖端技術上的投資，中國的地位都在迅速攀升。目前，中國貢獻全球新藥 Pipeline 的23%，也在生物製劑、精準醫療和合成生物學等領域處於領先地位。

但是，中國能否重塑全球生技產業格局，搖身一變成為這個領域的 Leader 呢？像「中國製造 2025（Made in China 2025）」和「健康中國 2030（Healthy China 2030）」這類的倡議為長期增長奠定基礎，中國的雄心壯志也顯而易見，但是地緣政治的挑戰、永續發展的問題、與國際接軌等複雜因素，都可能影響中國生技業的發展軌跡。

過去十年，中國生物製藥創新生態系統透過漸進式改善而不斷演進，與國家法規、政策支持、保險給付框架、整個產業鏈基礎設施的發展、人才培養和產學研合作這類軟實力等多方面因素都有相關。中國政府在 2015 年發布的《國務院關於改革藥品醫療器材審評審批制度的意見（Opinions of the State Council on Reforming the Review and Approval System for Drugs and Medical Devices）》旨在促進和加速創新的監管改革，而國家醫保藥品目錄（National Reimbursement Drug List，NRDL）的延伸則是中國改善醫療可近性並促進生物製藥創新策略的基石。2016 年啟動的「健康中國 2030」倡議的目標是在 2030 年將國家衛生服務產業價值提升到 20 億美元，與早期的「中國製造 2025」策略密切相關，把生物製藥列為國家發展的十大關鍵領域之一。

中國也在十個城市建立生物製藥創新中心，促進協作並加強產業能力，其中三個地區脫穎而出，成為中國生物製藥發展的核心 — — 長三角地區（上海、蘇州、杭州）、京津冀地區、大灣區（廣州、深圳、香港）。到 2023年，有 89 種新藥上市，中國批准的新藥數量比 2018 年增加 7 倍。此外，從新藥臨床試驗申請（Investigational New Drug，IND）到獲得許可的時間顯著縮短 — — 從 2015 年將近 600 天到 2023 年不到 100 天。

中國生物製藥領域的研發支出也呈現爆發式的增長：到 2023 年，中國生物製藥研發總支出達到 150 億美元，相較於 2015 年的 3500 萬美元，增幅可說是相當驚人。雖然與美國 2023 年 960 億美元的製藥業研發支出相比仍有一段差距，但中國每年約 10% 的研發增長率顯示出強勁的發展趨勢。長期可持續的資金挹注是推動中國快速發展的關鍵因素之一，政府採取了一系列措施來支持生物科技產業的發展，研發支出也越來越多投向尖端技術，如細胞和基因療法、mRNA 疫苗、人工智慧（AI）輔助藥物研發。2023 年，中國公司開發的新藥中有 58% 是生物製劑，抗體藥物複合體（Antibody Drug Conjugate，ADC）、雙特異性抗體（Bispecific Antibody）和 CAR-T 療法的研發 Pipeline 則分別增加了七倍、五倍和四倍。

中國政府也非常重視「軟實力」的建設，推出多項人才培育計劃：

1. 「千人計劃 Thousand Talents Program」：旨在吸引國際頂尖科學家和研究人員到中國工作，為海外華人學者和外國專家提供具有競爭力的獎勵政策。

2. 中美生物化學考試及申請（China-United States Biochemistry Examination and Application，CUSBEA）計劃：1981 年至 1989 年間運作，促進中國學生在美國的培訓，其中許多人已回國為中國生物科技產業服務。

3. 與產業領導者合作：如默克 Merck 與北京生物谷的合作，旨在為中國生物製藥業建立技術培訓計劃。

2015 年至 2023 年間，中國發表的科學論文數量位居全球第二，達 5,282 篇；雖然美國仍以超過 7,000 篇的發表量領先，但中國的進步速度也是相當地快。

中國的 CDMO 以及臨床研究機構（Clinical Research Organization，CRO）已成為全球生物製藥公司不可或缺的合作夥伴。像藥明康德 WuXi AppTec、龍沙中國 Lonza China 和康龍化成 Pharmaron 等企業以其全方位的服務能力聞名，從藥物開發 Drug Discovery、臨床前期研究 Preclinical Research 到大規模生產，都能以遠低於歐美的成本來提供服務。然而，《生物安全法案》（BIOSECURE Act）的通過可能會對中國製藥業產生重大影響，特別是在全球對生物製藥供應鏈和國安問題的重視越來越顯著的背景下，這個法案可能會阻礙中國製藥進入美國市場，對依賴出口的中國公司現金流造成不利影響。此外，如果美國公司被鼓勵從國內或盟國採購原料，中國企業可能會進一步與市場隔絕。這些影響可能超出了美中關係的範疇，也可能會對在美國運營的外國製藥公司加上更嚴格的監管要求。中國企業可能面臨更嚴格的製造生產、數據完整性和安全標準合規性審查。

不過，中國製藥業仍有蠻大加強國內市場的機會和潛力，隨著對自給自足和國內創新的需求增加，中國可以加強發展內部的生物製藥生態系，減少對外國市場的依賴。投資本地研發計劃可以讓中國企業在不斷變化的全球格局中保持其地位。對於台灣的醫療從業者和生醫產業投資者來說，一方面中國市場的不確定性可能為台灣企業創造新的機會（尤其是在與美國和其他西方國家的合），另一方面，台灣企業也需要留意地緣政治的風險，思考如何在中美競爭加劇的脈絡下做好自我定位。同時，台灣可以借鑒中國在建立完整生物製藥產業鏈方面的經驗，加強本土研發和生產能力，提升在全球生技產業中的競爭力。

2024 年中國生物科技熱門的研究領域包括核酸技術、多肽藥物、抗體藥物複合體（ADCs）、雙特異性抗體、細胞和基因療法、放射性藥物，在 CAR-T 療法取得顯著進展：截至 2023 年，已註冊超過 300 項臨床試驗，使中國成為全球 CAR-T 研發的領導者之一，傳奇生物科技 Legend Biotech 和信達生物 Innovent Biologics 等中國公司在針對血液科惡性腫瘤的 CAR-T 療法取得了很不錯的成果，目前也已進入國際市場。本地生產的 CAR-T 療法大幅降低治療成本，在中國，CAR-T 的平均成本在 5.5 萬至 35 萬美元之間，遠低於美國 50 萬至 100 萬美元的價格。

中國在 mRNA 研究同樣投入巨資，艾博生物科技 Abogen Biosciences 和沃森生物 Walvax Biotechnology 等公司是主要 Player 之二，沃森生物的 mRNA 新冠疫苗於 2022 年在國內獲得批准；除了疫苗，中國還在探索 mRNA 技術在 Oncology 和罕見疾病治療方面的潛力。此外，中國在 CRISPR 技術和基因編輯應用的進展，包括 2023年有超過 30 種基因編輯療法正在不同的開發階段，研究機構和生物科技公司也在利用 CRISPR-Cas9 和鹼基編輯技術來治療血友病和癌症。

截至 2024 年 8 月，中國新藥 Pipeline 有 5,380 個，佔全球總數的三分之一以上，幾乎與美國持平。人工智慧技術也為中國的藥物研發帶來新的可能性，如杭州的 MindRank 公司利用 AI 藥物發現的技術開發了一種針對肥胖和第 2 型糖尿病的小分子藥物 MDR-001，使研究團隊能夠在短短 8 個月內從近 100 個分子當中迅速找出一個臨床前期候選藥物。

儘管中國生物科技產業在過去十年取得很不錯的進展，但未來幾十年中國生物科技生態系可能會迎來更多挑戰，全球商業化和發展仍然是中國生物製藥產業面臨的困難，企業在開發新藥時仍然缺乏必要的全球商業經驗和人才，考量到全球醫療照護市場的複雜性和快速變化，再加上政策的不確定性，新進者要在這個領域站穩腳跟確實異常困難。此外，中國在基礎研究方面與領先國家依然存在一定的差距，要看到重大突破和實質變化還需要更長的時間，因為儘管政府投入大量資金，基礎研究的成果往往需要長期積累，並建立更加完善的產學研合作機制。隨著在中國進行的臨床試驗數量增加，越來越多的中國醫師有機會參與跨國臨床試驗，讓中國醫師能夠深入了解中國的藥物開發和臨床試驗設計，長遠來看可能成為中國生物科技產業的一大優勢。

對於台灣的醫療從業者和生醫產業投資者來說，中國市場的快速發展可能帶來新的合作機會，特別是在基礎研究和臨床試驗領域。中國企業在全球商業化過程中積累的經驗，無論是成功還是失敗，也都將為台灣企業提供寶貴的借鑒，而參與中國的跨國臨床試驗也可能是一個積累國際經驗的好機會。隨著中國在全球生物科技產業中的地位不斷提升，台灣企業在制定長期策略時，需要思考中國可能帶來的競爭和機遇，如何在這個快速變化的環境中找到自己的定位，利用自身優勢參與全球競爭，將是我們需要深入思考的問題。

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📒 Compiled by — 台中慈濟醫院復健科 R3 陳佳菁醫師 Sigrid Chen, PM&R Resident Physician at Taichung Tzu Chi Hospital, Taiwan; Former Medical Consultant at ASUS Intelligent Cloud Services.

26 thoughts on “中國生技製藥產業的 Next Decade？”

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    apparent change that provides the desired ‘ripped’ look to one’s appearance.
    Regardless Of their subtlety, the real effects of these transformations culminate to make
    Anavar’s contribution to bodybuilding quite very important.
    Furthermore, the fat-burning effects of Anavar turn into significantly
    more evident.
    This is an indication of elevated physique temperature and probably increased blood stress.
    People with existing high blood pressure or those genetically prone to heart disease should not take Anavar or different steroids because of
    negative redistribution of levels of cholesterol. Anavar and all anabolic steroids are primarily types of exogenous testosterone; thus, Anavar will enhance muscle mass.
    Anavar (Oxandrolone) is actually a really versatile
    steroid and stacks very nicely for many forms of targets.
    The most common dosage can range from 20mgs as a lot as 80mgs for males per day, and for females
    a dosage is as much as 15mgs per day. There may even be some
    liver toxicity; nevertheless, with the presence of two
    injectable steroids (testosterone and trenbolone), will in all probability be less hepatotoxic than the Dianabol/Anadrol
    cycle.
    If someone currently has insufficient well being and then takes this cycle,
    it’s more doubtless to deteriorate additional. Now we’ve taken a take a look
    at the varied factors that impact Oxandrolone dosage, it’d
    be sensible to ‘plug’ this information in and use it for a couple of real-world examples.
    After all, the above info, although important, does not truly
    tell you how a lot Anavar to take. Click On here now to get the
    best deal on Anvarol and start your journey in direction of
    achieving your physique objectives safely.
    There are also blood stress kits you can buy online,
    enabling you to watch your ranges much more incessantly. The
    reason it is considerably extra well-liked with ladies is because
    of the truth that there are not a lot of androgenic unwanted
    effects. Anvarol mimics ATP’s muscle-building results
    for strength and definition. It boosts phosphocreatine stores to increase reps
    during intense exercises.
    Although Anavar will nearly actually cause a reduction in endogenous testosterone levels when used, even in small doses, it might possibly nonetheless be used alone.

    When DHT’s are used, they’ll trigger the prostate to enlarge or trigger issues in this area.
    Sadly, in terms of prostate enlargement, there’s a double-edged sword.

    That is that DHT and estrogen are both elements in relation to
    prostate enlargement and issues. DHT is a potent inhibitor of estrogen,
    and estrogen may also be an issue.
    One of the primary advantages of Anavar for athletes and bodybuilders
    is its capability to advertise lean muscle positive aspects.

    Unlike other anabolic steroids that may trigger vital
    water retention and bloating, Anavar ensures that the muscle positive
    aspects are pure and outlined. This leads to a more aesthetically pleasing physique,
    which is very wanted in competitive bodybuilding and health circles.
    The high quality of muscle gained with Anavar is commonly described as exhausting and vascular, contributing to
    a more chiseled appearance.
    Anavar raises T3 by making TBG (thyroid-binding globulin) less effective
    and TBP (thyroxine-binding prealbumin) more effective. This is useful information for
    bodybuilders, as T4 (thyroxine) is the inactive thyroid hormone, and
    T3 is the hormone that stimulates fats loss.
    Essentially, it has less of an impression on intercourse traits and more on muscle
    tissue. Like different medication, it has trickled down into
    the leisure world, where it’s usually used to dramatically enhance muscle mass and even aid
    in a fats loss endeavor. Winstrol is a slicing steroid that produces vital results, especially
    when stacked with different steroids. Nonetheless, we know
    Winstrol’s side effects are simply as potent as the results it yields.

    Do not start, stop, or change the dosage of any medicines with out your physician’s
    approval. This drug may also have an result on your ldl cholesterol and may improve your risk of
    heart or blood vessel issues (coronary artery disease).
    10 mg/day of Anavar, in cycles lasting 4–5 weeks,
    is unlikely to cause any points with regard to masculinization (11).
    Anavar has a relatively low risk of causing virilization in girls when taken in therapeutic
    dosages. However, bodybuilders usually take 25 mg/day of Winstrol; thus, we conclude that a average dose of Winstrol has a extra devastating effect
    than a moderate dose of Anavar. Thus, Anavar will cause a notable enhance in blood strain when taking
    a reasonable dose. When it involves the Winstrol vs.
    Anavar debate, some bodybuilders opt for Anavar, and others choose Winstrol (for
    numerous reasons that we’re going to cover).

    References:

    Steroids With Less Side Effects – Sugarmummyarab.Com –

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  26. This effect creates an outlined and full look on Anavar, whereas on Winstrol, a
    toned appearance is widespread, but with much less of a pump to the muscle tissue.

    Muscle fullness is probably the one space where Anavar beats Winstrol relating to the benefits of every steroid.
    In phrases of administration, Anavar comes as an oral
    tablet like Winstrol. The chemical constructions of Winstrol and Anavar are
    comparable, with both compounds being modified types of
    dihydrotestosterone.
    The only warning was that pregnant women ought to chorus from using the drug.
    DHT (dihydrotestosterone) is a powerful androgen that binds
    to hair follicles on the scalp, leading to miniaturization and inhibited progress.
    However, it is not merely strength and endurance athletes
    that will profit from Anavar, with some sprinters,
    swimmers, and boxers additionally using Anavar to gain a aggressive edge.
    A general rule with steroids is that the extra pronounced the results, the more severe
    the side effects are. Beginner bodybuilders seeking to add a modest amount of muscle incessantly use it because of its less poisonous nature.

    Still, it is wise to monitor liver enzymes throughout usage as a precaution. Anavar is broadly used in managing muscle-wasting illnesses, corresponding to these attributable to HIV/AIDS and
    sure cancers. These circumstances often end
    in cachexia, a syndrome marked by extreme muscle atrophy and weight loss.

    This can present safety issues, so you need to solely consider a provider with a stable
    reputation for delivering a excessive quality product.
    Others find that testosterone suppression is lots greater than expected.
    Sudden water retention is another occasional adverse comment users make about Anavar – but these individuals are nearly
    actually victims of buying counterfeit Anavar. As anticipated, most reviews and experiences from real people using Anavar are optimistic.

    When implementing the aforementioned cycle, you will need to
    frequently monitor ALT and AST liver enzymes, as
    both compounds are C-17 alpha-alkylated. Our exams point out
    that orals usually tend to lead to hepatic harm.
    Nevertheless, clenbuterol does not induce any
    of these opposed effects, and in consequence, it has been a stacking option for women and
    men. The physique is subjected to higher ranges of
    toxicity when Anavar is mixed with Winstrol, as evidenced by
    our lipid profile and liver perform exams. Anavar is an oral steroid,
    whereas testosterone is primarily an injectable steroid.
    Consequently, another stack may be more acceptable for individuals with trypanophobia who want to keep away from needles.

    Sure, all steroid cycles must be adopted up with post-cycle remedy to each retain your features
    and restore your normal hormone function. The PCT you undertake after utilizing Anavar and the timing of it’ll
    even be decided by some other steroids you’re utilizing.
    A basic PCT cycle should consist of SERMs such as Nolvadex and Clomid, which can be much more environment friendly when mixed with
    HCG.
    HGH is thought to trigger water retention, with the wrists being a standard drawback area.
    The outcomes men can count on will once more closely depend on the purpose of use.
    Not Like standard AAS cycles, you can’t put a figure on expected gains
    with HGH as a end result of it’ll enhance your steroid cycles rather than appearing as a standalone muscle builder.
    Low doses of HGH could be very effective for the model new person or those just eager to expertise some benefits (like
    higher skin, hair, restoration, and sleep) with out going overboard.

    We have discovered the risk of virilization to increase when stacking Anavar and
    Winstrol together. Thus, we only see this attempted in certain circumstances, similar to making ready for an necessary competitors where there’s
    stress to put high. With very cautious doses (5 mg), it might be possible
    to avoid virilizing unwanted effects; nevertheless, every
    lady may respond in a special way. Superior users can lengthen the duration to eight weeks; nevertheless,
    this is not advised. Andriol is the brand name for oral testosterone, also called testosterone undecanoate.
    The drawback to oral testosterone is that it’s notably dearer than injectable
    testosterone.
    By following a structured cycle, customers goal to
    maximize the advantages of Anavar while minimizing potential dangers and unwanted aspect effects.
    Understanding the key parts and issues of an Anavar cycle is essential for attaining desired results and sustaining total well
    being and well-being. Lastly, Anavar binds to androgen receptors in the body, triggering specific cellular responses.
    This activation can end result in increased muscle energy, improved restoration, and enhanced athletic performance total.
    Finally, the decision to use Anavar must be based mostly
    on an intensive assessment of your fitness goals, health status, and willingness to adhere to protected utilization practices.
    Consulting with healthcare professionals, ideally these skilled with performance-enhancing substances, can provide priceless insights and assist you to
    make an informed choice. Anavar is often a highly effective tool in attaining
    peak efficiency and an outlined physique, however
    like any highly effective tool, it have to be used responsibly and with due diligence.

    Thus, it is unlikely that somebody can be examined
    for steroids in the military, particularly if they’re quiet
    about their use. Clenbuterol works by stimulating
    thermogenesis, causing a rise in physique temperature, and elevating the metabolism.
    It also stimulates lipolysis by instantly targeting fats cells through the elimination of triglycerides.

    References:

    what are the positive effects of steroids

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