YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 435 drug applications between 29 November 2025 and 5 December 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 93, covering 73 drug names.
2025/11/29 – 2025/12/05
- New acceptances this week
- 435
- Drugs with new generic filings (by drug name, de-duplicated)
- 73
- Accepted this week, now under review
- 106
DefinitionAcceptance numbers accepted this week that still appear on CDE's under-review list at the data cutoff; counted by acceptance date from the daily full pull of that list, independent of snapshot history.
Names with a public page are linked.
New acceptances this week
By application type and drug type
435filings, 93 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 226 |
| Generic | 93 |
| New drug | 71 |
| Import | 29 |
| Unspecified | 8 |
| Import re-registration | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 249 |
| TCM | 121 |
| Therapeutic biologic | 60 |
| Biologic | 4 |
| Prophylactic biologic | 1 |
DefinitionAcceptance numbers whose acceptance date falls in this week; application type and drug type are the CDE list's own text, with empty values shown as “Unspecified”.
Most new generic filings, by drug
73 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Riociguat Tablets | 3 | 1 | 4 |
| 2 | Mupirocin Ointment | 2 | 2 | 30 |
| 3 | Tadalafil Tablets | 2 | 1 | 23 |
| 4 | 奥洛他定莫米松鼻喷雾剂 · No verified English name | 2 | 1 | 1 |
| 5 | 恩曲替尼胶囊 · No verified English name | 2 | 1 | 6 |
| 6 | Lafutidine Tablets | 2 | 1 | 2 |
| 7 | Teneligliptin Hydrobromide Hydrate Tablets | 2 | 1 | 10 |
| 8 | 生理氯化钠溶液 · No verified English name | 2 | 1 | 17 |
| 9 | 甲氧氯普胺片 · No verified English name | 2 | 1 | 3 |
| 10 | Levocetirizine dihydrochloride Oral Solution | 2 | 1 | 5 |
DefinitionThis week's acceptance numbers with application type “Generic”, grouped by identical drug name; filing companies are de-duplicated by first applicant; under review, all years = acceptance numbers for that name, from any year, still on the CDE under-review list. Top 10 by filings, then companies.
Most new acceptances, by company
247 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Fu Song Xian Zhong Yao Co., Ltd. romanized | 29 | 29 | 0 |
| 2 | Eli Lilly and Company | 12 | 1 | 0 |
| 3 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 6 | 2 | 0 |
| 4 | Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | 6 | 1 | 0 |
| 5 | Ai Min Pharma Group Co., Ltd. romanized | 5 | 5 | 0 |
| 6 | Beijing Sai Er Bio Pharma Co., Ltd. romanized | 5 | 4 | 5 |
| 7 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized | 5 | 4 | 0 |
| 8 | Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized | 5 | 1 | 0 |
| 9 | Hangzhou Nuo Ao Biopharmaceuticals Technology Co., Ltd. romanized | 5 | 1 | 0 |
| 10 | Guangzhou Bai Yun Shan Hua Cheng Pharma Co., Ltd. romanized | 4 | 4 | 0 |
DefinitionThis week's acceptance numbers grouped by first applicant; drugs are de-duplicated by drug name; “Generic” counts filings with application type “Generic”. Top 10 by filings.
Under-review list changes
Compared across this platform's snapshots of the under-review list
Data collected since 2026/10/22. There is not enough snapshot history for this week yet; counts of filings entering and leaving review start with the next complete week.
DefinitionEntered review = acceptance numbers seen for the first time in this platform's under-review snapshots this week, excluding the baseline records of the first snapshot day (2026/10/22). Left review = acceptance numbers whose last snapshot sighting falls in this week and that this snapshot no longer lists; the outcome follows NMPA's approval-document delivery notices, and numbers without such a record are marked to be checked. Companies are counted by first applicant.
Class 3 and new-drug acceptances
129 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/12/05Generic · Class 3 | 甲氧氯普胺片 · No verified English nameCYHS2504187 | Ka Wen Di Xu (Tai Zhou) Pharma Co., Ltd. romanized; Jiangsu Yue Xing Pharma Co., Ltd. romanized |
| 2025/12/05Generic · Class 3 | 甲氧氯普胺片 · No verified English nameCYHS2504186 | Ka Wen Di Xu (Tai Zhou) Pharma Co., Ltd. romanized; Jiangsu Yue Xing Pharma Co., Ltd. romanized |
| 2025/12/05Generic · Class 3 | Lafutidine TabletsCYHS2504181 | Su Zhong Pharma Group Co., Ltd. romanized |
| 2025/12/05Generic · Class 3 | Lafutidine TabletsCYHS2504180 | Su Zhong Pharma Group Co., Ltd. romanized |
| 2025/12/05Generic · Class 3 | 盐酸精氨酸注射液 · No verified English nameCYHS2504175 | Beijing Bai Ya Joint Drug Research Institute Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized |
| 2025/12/05Generic · Class 3 | Alendronate Sodium Oral SolutionCYHS2504172 | Shaanxi Xin Feng Hua Bio Technology Co., Ltd. romanized; Shaanxi Han Jiang Pharma Group Co., Ltd. romanized |
| 2025/12/05Generic · Class 3 | Minoxidil LinimentCYHS2504171 | Hunan Jiudian Pharmaceutical Co., Ltd; Hangzhou Wan Bang Tian Cheng Pharma Co., Ltd. romanized |
| 2025/12/05Generic · Class 3 | Isosulfan Blue InjectionCYHL2500216 | HUNAN WARRANT PHARMACEUTICAL CO.,LTD |
| 2025/12/05New drug · Class 1 | HS-20117注射液 · No verified English nameCXSL2501050 | Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Changzhou Heng Bang Pharma Co., Ltd. romanized |
| 2025/12/05New drug · Class 1 | 注射用HS-20122 · No verified English nameCXSL2501049 | Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Changzhou Heng Bang Pharma Co., Ltd. romanized |
| 2025/12/05New drug · Class 1 | 注射用SHR-A2102 · No verified English nameCXSL2501048 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/12/05New drug · Class 1 | 注射用SHR-1826 · No verified English nameCXSL2501047 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2025/12/05New drug · Class 1 | 注射用SHR-A2009 · No verified English nameCXSL2501046 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2025/12/05New drug · Class 1 | 注射用ZHB130 · No verified English nameCXSL2501045 | Jiangsu Zhong Hong Bio Gong Cheng Chuang Yao Research Institute Co., Ltd. romanized |
| 2025/12/05New drug · Class 1 | 注射用SHR-A2102 · No verified English nameCXSL2501044 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/12/05New drug · Class 2.2 | SHR-8068注射液 · No verified English nameCXSL2501043 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2025/12/05New drug · Class 1 | 注射用MK-1045 · No verified English nameCXSL2501042 | Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized |
| 2025/12/05New drug · Class 1 | 注射用MK-1045 · No verified English nameCXSL2501041 | Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized |
| 2025/12/05New drug · Class 1 | PA3-17注射液 · No verified English nameCXSL2501040 | Bo Sheng Ji An Ke Xi Bao Technology Co., Ltd. romanized; Bo Sheng Ji Pharmaceuticals Technology (Suzhou) Co., Ltd. romanized |
| 2025/12/05New drug · Class 1 | HS-10504片 · No verified English nameCXHL2501339 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/12/05New drug · Class 1 | HS-10504片 · No verified English nameCXHL2501338 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/12/05New drug · Class 2.2 | 司美格鲁肽片 · No verified English nameCXHL2501337 | Hangzhou Nuo Ao Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/12/05New drug · Class 2.2 | 司美格鲁肽片 · No verified English nameCXHL2501336 | Hangzhou Nuo Ao Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/12/05New drug · Class 2.2 | 司美格鲁肽片 · No verified English nameCXHL2501335 | Hangzhou Nuo Ao Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/12/05New drug · Class 2.2 | 司美格鲁肽片 · No verified English nameCXHL2501334 | Hangzhou Nuo Ao Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/12/05New drug · Class 2.2 | 司美格鲁肽片 · No verified English nameCXHL2501333 | Hangzhou Nuo Ao Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/12/05New drug · Class 1 | GSBR-5746片 · No verified English nameCXHL2501332 | Shanghai Shuo Di Bio Technology Co., Ltd. romanized |
| 2025/12/05New drug · Class 1 | GSBR-5746片 · No verified English nameCXHL2501331 | Shanghai Shuo Di Bio Technology Co., Ltd. romanized |
| 2025/12/05New drug · Class 1 | GSBR-5746片 · No verified English nameCXHL2501330 | Shanghai Shuo Di Bio Technology Co., Ltd. romanized |
| 2025/12/05New drug · Class 1 | GSBR-5746片 · No verified English nameCXHL2501329 | Shanghai Shuo Di Bio Technology Co., Ltd. romanized |
99 more not listed (at most 30 rows).
DefinitionThis week's acceptance numbers with application type “New drug”, or registration applications whose class starts with 1, 2 or 3 (supplements and re-registrations excluded); newest first, at most 30 rows.
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