YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 398 drug applications between 27 November 2025 and 3 December 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 82, covering 66 drug names.
2025/11/27 – 2025/12/03
- New acceptances this week
- 398
- Drugs with new generic filings (by drug name, de-duplicated)
- 66
- Accepted this week, now under review
- 98
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
398filings, 82 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 211 |
| Generic | 82 |
| New drug | 69 |
| Import | 21 |
| Unspecified | 10 |
| Import re-registration | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 231 |
| TCM | 103 |
| Therapeutic biologic | 59 |
| Biologic | 3 |
| Prophylactic biologic | 2 |
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
66 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Pemafibrate Tablets | 2 | 2 | 23 |
| 2 | Crisaborole Ointment | 2 | 2 | 26 |
| 3 | Mupirocin Ointment | 2 | 2 | 30 |
| 4 | Tadalafil Tablets | 2 | 1 | 23 |
| 5 | 复方电解质醋酸钠葡萄糖注射液 · No verified English name | 2 | 1 | 22 |
| 6 | Levonorgestrel Tablets | 2 | 1 | 5 |
| 7 | Teneligliptin Hydrobromide Hydrate Tablets | 2 | 1 | 10 |
| 8 | 生理氯化钠溶液 · No verified English name | 2 | 1 | 17 |
| 9 | Levocetirizine dihydrochloride Oral Solution | 2 | 1 | 5 |
| 10 | Clopidogrel Hydrogen Sulphate Tablets | 2 | 1 | 6 |
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
230 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Fu Song Xian Zhong Yao Co., Ltd. romanized | 17 | 17 | 0 |
| 2 | Henan He Zhi Pharmaceuticals Technology Co., Ltd. romanized | 9 | 9 | 0 |
| 3 | Novo Nordisk A/S | 9 | 2 | 0 |
| 4 | Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | 7 | 2 | 1 |
| 5 | Merck Sharp & Dohme LLC | 6 | 5 | 0 |
| 6 | Amgen Inc. | 6 | 2 | 0 |
| 7 | Rui Li Shi Wan Ting Min Xin Pharmaceutical Co., Ltd. romanized | 6 | 2 | 0 |
| 8 | Xian Le Xi Medical Technology Co., Ltd. romanized | 5 | 5 | 0 |
| 9 | Beijing Sai Er Bio Pharma Co., Ltd. romanized | 5 | 4 | 5 |
| 10 | Merck Sharp & Dohme B.V. | 5 | 3 | 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
115 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/12/03Generic · Class 3 | Tirofiban Hydrochloride And Sodium Chloride InjectionCYHS2504156 | Jiangsu Chang Jiang Pharma Co., Ltd. romanized |
| 2025/12/03Generic · Class 3 | 生理氯化钠溶液 · No verified English nameCYHS2504148 | Shanghai Chang Zheng Fu Min Jin Shan Pharmaceutical Co., Ltd. romanized |
| 2025/12/03Generic · Class 3 | 生理氯化钠溶液 · No verified English nameCYHS2504147 | Shanghai Chang Zheng Fu Min Jin Shan Pharmaceutical Co., Ltd. romanized |
| 2025/12/03Generic · Class 3 | Hydrotalcite SuspensionCYHS2504146 | China Resources Sanjiu Medical & Pharmaceutical Co.,Ltd.; Hua Run San Jiu (Tang Shan) Pharma Co., Ltd. romanized |
| 2025/12/03Generic · Class 3 | Heparin Sodium InjectionCYHS2504145 | Suzhou Erye Pharmaceutical Co., Ltd |
| 2025/12/03Generic · Class 3 | 维生素B12注射液 · No verified English nameCYHS2504142 | Name not romanized; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized |
| 2025/12/03Generic · Class 3 | 酮洛芬凝胶贴膏 · No verified English nameCYHL2500212 | Shaanxi Pan Long Pharma Group Co., Ltd. romanized |
| 2025/12/03New drug · Class 3.3 | 地舒单抗注射液 · No verified English nameCXSS2500128 | Fu Xing Han Lin (Shenzhen) Bio Technology Co., Ltd. romanized; Shanghai Fu Hong Han Lin Biopharmaceuticals Co., Ltd. romanized |
| 2025/12/03New drug · Class 3.3 | 地舒单抗注射液 · No verified English nameCXSS2500127 | Fu Xing Han Lin (Shenzhen) Bio Technology Co., Ltd. romanized; Shanghai Fu Hong Han Lin Biopharmaceuticals Co., Ltd. romanized |
| 2025/12/03New drug · Class 2.2 | 注射用MK-2870 · No verified English nameCXSL2501037 | Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized |
| 2025/12/03New drug · Class 2.2 | 注射用MK-2870 · No verified English nameCXSL2501036 | Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized |
| 2025/12/03New drug · Class 1 | GKL-006Allo注射液 · No verified English nameCXSL2501035 | Beijing Ji Yin Qi Ming Bio Technology Co., Ltd. romanized |
| 2025/12/03New drug · Class 2.1 | 卡度尼利单抗注射液(皮下注射) · No verified English nameCXSL2501034 | Kang Fang Pharma Co., Ltd. romanized |
| 2025/12/03New drug · Class 1 | 脐带血巨核细胞注射液 · No verified English nameCXSL2501033 | Suzhou Xue Ji Bio Technology Co., Ltd. romanized |
| 2025/12/03New drug · Class 1 | XTYW007片 · No verified English nameCXHL2501328 | Xian Xin Tong Drug Research Co., Ltd. romanized |
| 2025/12/03New drug · Class 1 | XTYW007片 · No verified English nameCXHL2501327 | Xian Xin Tong Drug Research Co., Ltd. romanized |
| 2025/12/03New drug · Class 1 | XTYW007片 · No verified English nameCXHL2501326 | Xian Xin Tong Drug Research Co., Ltd. romanized |
| 2025/12/03New drug · Class 2.2 | SYH9089注射液 · No verified English nameCXHL2501325 | Beijing Kang Chuang Lian Biopharmaceutical Technology Research Co., Ltd. romanized; CSPC OUYI PHARMACEUTICAL CO., LTD. |
| 2025/12/03New drug · Class 1 | SY-9453胶囊 · No verified English nameCXHL2501324 | Shou Yao Holding (Beijing) Co., Ltd. romanized |
| 2025/12/03New drug · Class 1 | SY-9453胶囊 · No verified English nameCXHL2501323 | Shou Yao Holding (Beijing) Co., Ltd. romanized |
| 2025/12/03New drug · Class 1 | XW014片 · No verified English nameCXHL2501322 | Hangzhou Xian Wei Da Bio Technology Co., Ltd. romanized |
| 2025/12/03New drug · Class 1 | XW014片 · No verified English nameCXHL2501321 | Hangzhou Xian Wei Da Bio Technology Co., Ltd. romanized |
| 2025/12/03New drug · Class 1 | ANS014004片 · No verified English nameCXHL2501320 | Beijing An Shi Bio Technology Co., Ltd. romanized |
| 2025/12/03New drug · Class 1 | ANS014004片 · No verified English nameCXHL2501319 | Beijing An Shi Bio Technology Co., Ltd. romanized |
| 2025/12/02Generic · Class 3 | 中性低钙腹膜透析液(碳酸氢盐-G2.5%) · No verified English nameCYHS2504138 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2025/12/02Generic · Class 3 | Norepinephrine Bitartrate InjectionCYHS2504126 | Shanxi Yang He Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Pu Heng Pharmaceutical Co., Ltd. romanized |
| 2025/12/02Generic · Class 3 | Norepinephrine Bitartrate InjectionCYHS2504125 | Shanxi Yang He Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Pu Heng Pharmaceutical Co., Ltd. romanized |
| 2025/12/02Generic · Class 3 | MOVICOL Ready To Take Sachet, Powder For Oral SolutionCYHS2504121 | Hangzhou Fu Ou Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Kai Run Pharma Co., Ltd. romanized |
| 2025/12/02Generic · Class 3 | Nafamostat Mesilate for InjectionCYHL2500211 | Tianjin Hong Ri Pharma Co., Ltd. romanized |
| 2025/12/02New drug · Class 1.1 | 疏肝解郁颗粒 · No verified English nameCXZS2500048 | Beijing Xing Hao Pharmaceuticals Co., Ltd. romanized; Kang Mei Bao Ning (Sichuan) Pharmaceutical Co., Ltd. romanized |
85 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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