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Linaclotide Capsules(利那洛肽胶囊)
Companies, stages and changes, with each record available on this page.
Last 90 days: Accepted: 5 applicationsApproval-document delivery record: 1 application
Current coverage may be incomplete
Which companies are listed, and at what stages?
Each source is counted separately. Expand a list to inspect companies, identifiers, dates and sources.
Company names, approval identifiers and strengths are retained as recorded in the Chinese sources. Category labels include the original wording for verification.
Catalogue holders4View records ↓
Under-review filings13View records ↓
This year’s generic filers6View records ↓
NHSA approval numbers3View records ↓
API companies with A status5View records ↓
Chemical-drug catalogue
Loaded records: 4 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 4 in the new chemical-registration-classification generic category. Category counts may overlap.
| Marketing authorization holder | Manufacturer | Approval number | Approved | Strength / specification | Catalogue category (source text) | View source |
|---|---|---|---|---|---|---|
| 江西科睿药业有限公司 | 江西科睿药业有限公司 | 国药准字H20266125 | 2026/09/29 | 290μg | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 成都圣诺生物制药有限公司 | 成都圣诺生物制药有限公司 | 国药准字H20265774 | 2026/09/02 | 290μg | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 四川国为制药有限公司 | 四川国为制药有限公司 | 国药准字H20264831 | 2026/06/17 | 290μg | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 湖北民康药业集团有限公司 | 南京海纳制药有限公司 | 国药准字H20265356 | 2026/07/28 | 290μg | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
Distinct full holder names; manufacturers are used only where the holder is unstated. The catalogue covers only part of the chemical-drug market. Categories are counted as recorded, not as a complete market census.
NHSA drug codes
Loaded records: 3 distinct approval numbers and 2 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| Almac Pharma Services Limited | 国药准字J20200012 | 290μg | Category B (乙) | XA06AXL374E001010101359 | NHSA |
| AstraZeneca AG | 国药准字HJ20190001 | 290μg | Category B (乙) | XA06AXL374E001010178450 | NHSA |
| Almac Pharma Services Limited | H20190002 | 290μg | Category B (乙) | XA06AXL374E001010182573 | NHSA |
| AstraZeneca AG | 国药准字HJ20190001 | 290μg | Category B (乙) | XA06AXL374E001010278450 | NHSA |
| Almac Pharma Services Limited | H20190002 | 290μg | Category B (乙) | XA06AXL374E001010282573 | NHSA |
Approval numbers and companies are deduplicated separately; packaging records remain individually listed. An empty insurance class means it is unstated. NHSA codes supply no approval date and do not establish the outcome of an acceptance number.
Current under-review applications
Loaded records: 13 filings and 13 distinct first applicants.
Generic 13
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 齐鲁制药（海南）有限公司 | CYHS2300919 | Generic | 2023/03/28 | Not stated by source | CDE |
| 苏州二叶制药有限公司 | CYHS2502007 | Generic | 2025/06/06 | Not stated by source | CDE |
| 深圳欣祺医药科技有限公司;江苏诚康药业有限公司 | CYHS2601201 | Generic | 2026/05/27 | Not stated by source | CDE |
| 远大医药（湖北）有限公司;药源生物科技（启东）有限公司 | CYHS2502478 | Generic | 2025/07/11 | Not stated by source | CDE |
| 苏州天马医药集团天吉生物制药有限公司;江苏飞马药业有限公司 | CYHS2302540 | Generic | 2023/09/20 | Not stated by source | CDE |
| 陕西汉唐制药有限公司;四川昇锐制药有限公司 | CYHS2602110 | Generic | 2026/08/25 | Not stated by source | CDE |
| 成都地奥制药集团有限公司;四川宏明博思药业有限公司 | CYHS2602062 | Generic | 2026/08/20 | Not stated by source | CDE |
| 浙江杭康药业有限公司 | CYHS2600113 | Generic | 2026/01/09 | Not stated by source | CDE |
| 成都诺和晟鸿生物制药有限公司;四川昇锐制药有限公司 | CYHS2503547 | Generic | 2025/09/28 | Not stated by source | CDE |
| 湖南明瑞制药股份有限公司 | CYHS2503362 | Generic | 2025/09/10 | Not stated by source | CDE |
| 双鹤药业（海南）有限责任公司 | CYHS2403334 | Generic | 2024/10/09 | Not stated by source | CDE |
| 佑华医药科技有限公司;郑州泰丰制药有限公司 | CYHS2602627 | Generic | 2026/10/26 | Not stated by source | CDE |
| 海南通用三洋药业有限公司 | CYHS2602670 | Generic | 2026/11/02 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 6 filings and 6 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 深圳欣祺医药科技有限公司;江苏诚康药业有限公司 | CYHS2601201 | Generic | 2026/05/27 | Not stated by source | CDE |
| 陕西汉唐制药有限公司;四川昇锐制药有限公司 | CYHS2602110 | Generic | 2026/08/25 | Not stated by source | CDE |
| 成都地奥制药集团有限公司;四川宏明博思药业有限公司 | CYHS2602062 | Generic | 2026/08/20 | Not stated by source | CDE |
| 浙江杭康药业有限公司 | CYHS2600113 | Generic | 2026/01/09 | Not stated by source | CDE |
| 佑华医药科技有限公司;郑州泰丰制药有限公司 | CYHS2602627 | Generic | 2026/10/26 | Not stated by source | CDE |
| 海南通用三洋药业有限公司 | CYHS2602670 | Generic | 2026/11/02 | Not stated by source | CDE |
API registrations
Non-component matches: 5 companies with A status and 9 I-status records. Component matches are listed separately and excluded from these counts.
| Name | Company / applicant | Registration number | Status | Name match | Source update date | View source |
|---|---|---|---|---|---|---|
| 利那洛肽 | 浙江肽昇生物医药有限公司 | Y20260000548 | I | Exact ingredient | 2026/07/23 | CDE |
| 利那洛肽 | 浙江尚泰生物制药有限公司 | Y20250001331 | I | Exact ingredient | 2025/12/11 | CDE |
| 利那洛肽 | 海南双成药业股份有限公司 | Y20250001041 | I | Exact ingredient | 2025/10/16 | CDE |
| 利那洛肽 | 湖南明瑞制药股份有限公司 | Y20250000681 | I | Exact ingredient | 2025/08/18 | CDE |
| 利那洛肽 | 四川伊诺达博医药科技有限公司 | Y20250000775 | I | Exact ingredient | 2025/08/07 | CDE |
| 利那洛肽 | 四川仁安药业有限责任公司 | Y20250000449 | I | Exact ingredient | 2025/05/13 | CDE |
| 利那洛肽 | 鲁南新时代生物技术有限公司 | Y20250000173 | I | Exact ingredient | 2025/03/12 | CDE |
| 利那洛肽 | 四川国为制药有限公司 | Y20240000603 | A | Exact ingredient | 2026/04/29 | CDE |
| 利那洛肽 | 成都圣诺生物制药有限公司 | Y20240000089 | A | Exact ingredient | 2026/03/02 | CDE |
| 利那洛肽 | 苏州天马医药集团天吉生物制药有限公司 | Y20230000696 | A | Exact ingredient | 2025/09/09 | CDE |
| 利那洛肽 | 翰宇药业（武汉）有限公司 | Y20220000680 | A | Exact ingredient | 2026/06/21 | CDE |
| 利那洛肽 | 中肽生化有限公司 | Y20210000906 | A | Exact ingredient | 2025/08/01 | CDE |
| 利那洛肽 | 成都圣诺生物制药有限公司 | Y20200001056 | I | Exact ingredient | 2020/11/06 | CDE |
| 利那洛肽 | PolyPeptide Laboratories (Sweden) AB | Y20190021407 | I | Exact ingredient | 2020/05/21 | CDE |
A/I are source statuses. Matching uses exact ingredients, salt-normalized names and maintained combination components, without fuzzy matching. A-status companies are deduplicated by the first registered company. Components are excluded from headline counts; the register does not identify the associated formulation.
What changed recently?
Last 90 days, ordered by fact date. Marketing approvals, trial registrations, supplements, notices and review changes are labelled separately.
Trial registration does not mean an application will follow.
This product is outside the trial-registration backfill scope. New registrations after daily collection started remain in scope. Historical rows may also be found by another product search; neither implies complete historical coverage for this product.
NHSA edition maintained to 2026-10-23; latest successful catalogue check: 2026/11/10 07:23. NHSA records lack approval dates; only an earlier edition or observation establishes precedence.
-
2026/11/02Accepted
-
2026/10/26Accepted
佑华医药科技有限公司;郑州泰丰制药有限公司
CYHS2602627
Fact date: 2026/10/26 · Site observation date: 2026/10/27
View source ↗ -
2026/10/16Approval-document delivery record
远大生命科学（山东）有限公司
JTH2600198
Fact date: 2026/10/16 · Publication date: 2026/10/19 · Site observation date: 2026/11/03
View source · Table row 30 ↗ -
2026/09/21Accepted
Almac Pharma Services Limited;AstraZeneca AG;远大生命科学（山东）有限公司
JTH2600198
Fact date: 2026/09/21 · Site observation date: 2026/10/22
View source ↗ -
2026/08/25Accepted
陕西汉唐制药有限公司;四川昇锐制药有限公司
CYHS2602110
Fact date: 2026/08/25 · Site observation date: 2026/10/22
View source ↗ -
2026/08/20Accepted
成都地奥制药集团有限公司;四川宏明博思药业有限公司
CYHS2602062
Fact date: 2026/08/20 · Site observation date: 2026/10/22
View source ↗
How current is each source?
- CDE acceptances and review
- Last successful update: 2026/11/10 07:27
- Chemical-drug catalogue
- Last successful update: 2026/11/10 07:23
Distinct full holder names; manufacturers are used only where the holder is unstated. The catalogue covers only part of the chemical-drug market. Categories are counted as recorded, not as a complete market census.
- Full API register
- Last successful update: 2026/11/10 07:25
- NHSA drug codes
- Last successful update: 2026/11/05 06:45
The fully loaded edition was maintained to 2026-10-23. Publication lags maintenance: the verified 2026-10-16 edition was published on 10-28, a 12-day gap. This is not a fixed lag for every edition.
- NMPA drug delivery notices
- Last successful update: 2026/11/10 18:31
First index-page publication dates: 2026-10-26 to 2026-11-10; 0 pages pending. Covers loaded notices only, not a complete historical approval database.
- Drug Clinical Trial Registry and Information Disclosure Platform
- Last successful update: 2026/11/10 08:10 · Current coverage may be incomplete
Daily collection reads new registrations. Backfill covers registration numbers from 2025 onward (CTR2025/CTR2026), not first-publication years. States are dated observations; revisions are not tracked.
This product is outside the trial-registration backfill scope. New registrations after daily collection started remain in scope. Historical rows may also be found by another product search; neither implies complete historical coverage for this product.
Public-product searches scanned: 3/30; discovered pending details: 20. Record counts in unscanned portions remain unknown.
Filings are counted by acceptance number and filing companies by first applicant. Strengths may have separate applications. Drug names are normalized only for width and whitespace; distinct generic names, dosage forms and combinations remain separate. Unstated strengths are marked. Company counts from different sources must not be added together.
Fact dates are approval dates, acceptance dates, trial first-publication dates or complete-snapshot observation dates, as applicable. Publication and site-observation dates are separate. Historical backfills are not current-period new events. Exit records cover currently inactive applications with an identifiable complete snapshot, not a full review history.
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