YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 305 drug applications between 14 November 2025 and 20 November 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 68, covering 49 drug names.
2025/11/14 – 2025/11/20
- New acceptances this week
- 305
- Drugs with new generic filings (by drug name, de-duplicated)
- 49
- Accepted this week, now under review
- 75
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
305filings, 68 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 142 |
| Generic | 68 |
| New drug | 64 |
| Import | 13 |
| Unspecified | 9 |
| Import re-registration | 9 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 180 |
| TCM | 78 |
| Therapeutic biologic | 34 |
| Prophylactic biologic | 7 |
| Biologic | 6 |
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
49 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Lisdexamfetamine Dimesylate capsules | 4 | 1 | 4 |
| 2 | Polyvinyl Alcohol Eye Drops | 3 | 3 | 24 |
| 3 | 二甲硅油乳剂 · No verified English name | 3 | 2 | 14 |
| 4 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution | 3 | 2 | 23 |
| 5 | MOVICOL Ready To Take Sachet, Powder For Oral Solution | 2 | 2 | 16 |
| 6 | 依伏卡塞片 · No verified English name | 2 | 1 | 9 |
| 7 | Furosemide Oral Solution | 2 | 1 | 8 |
| 8 | Ibuprofen Granules | 2 | 1 | 3 |
| 9 | Tolvaptan Orally Disintegrating Tablets | 2 | 1 | 5 |
| 10 | 氯雷他定糖浆 · No verified English name | 2 | 1 | 7 |
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
194 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Bayer Vital GmbH | 14 | 1 | 0 |
| 2 | Qinghai Jiu Mei Cang Pharmaceuticals Technology Co., Ltd. romanized | 8 | 8 | 0 |
| 3 | Jin Yao Da Ren Tang Group Co., Ltd. Le Ren Tang Pharmaceutical Factory romanized | 5 | 5 | 0 |
| 4 | Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized | 5 | 4 | 2 |
| 5 | Qilu Pharmaceutical Co., Ltd. | 5 | 4 | 1 |
| 6 | Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | 5 | 2 | 2 |
| 7 | Guangdong Zhong Sheng Rui Chuang Bio Technology Co., Ltd. romanized | 5 | 1 | 0 |
| 8 | Eli Lilly and Company | 4 | 3 | 0 |
| 9 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 4 | 2 | 0 |
| 10 | Sichuan Kai Jing Pharmaceutical Co., Ltd. romanized | 4 | 1 | 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
107 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/11/20Import · Class 1 | AMO959硬胶囊 · No verified English nameJXHL2500359 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2025/11/20Import · Class 2.4 | 镥(177Lu)vipivotide tetraxetan注射液 · No verified English nameJXHL2500358 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2025/11/20Import · Class 1 | AMO959硬胶囊 · No verified English nameJXHL2500357 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2025/11/20Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2504012 | Zhong Shan Ke Ke Kang Pharmaceutical Co., Ltd. romanized |
| 2025/11/20New drug · Class 1 | SHR-1894注射液 · No verified English nameCXSL2500990 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2025/11/20New drug · Class 1 | EHT102注射液 · No verified English nameCXSL2500989 | Shanghai You Yin Pharmaceuticals Bio Technology Co., Ltd. romanized |
| 2025/11/20New drug · Class 1 | SYS6010 · No verified English nameCXSL2500988 | Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized |
| 2025/11/20New drug · Class 2.4 | 芦沃美替尼片 · No verified English nameCXHS2500140 | Shanghai Fu Xing Pharmaceuticals Industry Development Co., Ltd. romanized; Kai Lai Ying Sheng Ming Ke Xue Technology (Tianjin) Co., Ltd. romanized |
| 2025/11/20New drug · Class 2.4 | 芦沃美替尼片 · No verified English nameCXHS2500139 | Shanghai Fu Xing Pharmaceuticals Industry Development Co., Ltd. romanized; Kai Lai Ying Sheng Ming Ke Xue Technology (Tianjin) Co., Ltd. romanized |
| 2025/11/20New drug · Class 1 | HSK42360-Na片 · No verified English nameCXHL2501283 | Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized |
| 2025/11/20New drug · Class 1 | CKBA乳膏 · No verified English nameCXHL2501282 | Jiangsu Bo Chuang Yuan Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/11/20New drug · Class 1 | CKBA乳膏 · No verified English nameCXHL2501281 | Jiangsu Bo Chuang Yuan Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/11/20New drug · Class 1 | CKBA乳膏 · No verified English nameCXHL2501280 | Jiangsu Bo Chuang Yuan Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/11/20New drug · Class 1 | ASP3082注射液 · No verified English nameCXHL2501279 | An Si Tai Lai (Zhongguo) Investment Co., Ltd. romanized |
| 2025/11/20New drug · Class 1 | RAY1225注射液 · No verified English nameCXHL2501278 | Guangdong Zhong Sheng Rui Chuang Bio Technology Co., Ltd. romanized |
| 2025/11/20New drug · Class 1 | RAY1225注射液 · No verified English nameCXHL2501277 | Guangdong Zhong Sheng Rui Chuang Bio Technology Co., Ltd. romanized |
| 2025/11/20New drug · Class 1 | RAY1225注射液 · No verified English nameCXHL2501276 | Guangdong Zhong Sheng Rui Chuang Bio Technology Co., Ltd. romanized |
| 2025/11/20New drug · Class 1 | RAY1225注射液 · No verified English nameCXHL2501275 | Guangdong Zhong Sheng Rui Chuang Bio Technology Co., Ltd. romanized |
| 2025/11/20New drug · Class 1 | RAY1225注射液 · No verified English nameCXHL2501274 | Guangdong Zhong Sheng Rui Chuang Bio Technology Co., Ltd. romanized |
| 2025/11/19Import · Class 1 | 盐酸伊可白滞素片 · No verified English nameJXHS2500133 | Janssen-Cilag International NV; JANSSEN CILAG S.P.A.; Xian Janssen Pharmaceutical Ltd. |
| 2025/11/19Generic · Class 3 | 利格列汀二甲双胍缓释片(I) · No verified English nameCYHS2504008 | Jiangsu Deyuan Pharmaceutical Co.,Ltd. |
| 2025/11/19Generic · Class 3 | Tolvaptan Orally Disintegrating TabletsCYHS2504007 | TIANJIN LISHENG PHARMACEUTICAL CO., LTD; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2025/11/19Generic · Class 3 | Lisdexamfetamine Dimesylate capsulesCYHS2504006 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2025/11/19Generic · Class 3 | Tolvaptan Orally Disintegrating TabletsCYHS2504005 | TIANJIN LISHENG PHARMACEUTICAL CO., LTD; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2025/11/19Generic · Class 3 | Lisdexamfetamine Dimesylate capsulesCYHS2504004 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2025/11/19Generic · Class 3 | Lisdexamfetamine Dimesylate capsulesCYHS2504003 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2025/11/19Generic · Class 3 | Glycerol Fructose And Sodium Chloride InjectionCYHS2504002 | Guangdong Da Xiang Pharmaceutical Co., Ltd. romanized |
| 2025/11/19Generic · Class 3 | Lisdexamfetamine Dimesylate capsulesCYHS2504001 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2025/11/19Generic · Class 3 | Glycerol Fructose And Sodium Chloride InjectionCYHS2504000 | Guangdong Da Xiang Pharmaceutical Co., Ltd. romanized |
| 2025/11/19Generic · Class 3 | 小儿复方氨基酸注射液(20AA) · No verified English nameCYHS2503999 | Yuan Da Yi Xue Ying Yang Ke Xue (Wuhan) Co., Ltd. romanized |
77 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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