YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 381 drug applications between 14 December 2023 and 20 December 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 101, covering 79 drug names.
2023/12/14 – 2023/12/20
- New acceptances this week
- 381
- Drugs with new generic filings (by drug name, de-duplicated)
- 79
- Accepted this week, now under review
- 2
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
381filings, 101 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 181 |
| Generic | 101 |
| New drug | 62 |
| Import | 18 |
| Unspecified | 14 |
| Import re-registration | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 268 |
| TCM | 67 |
| Therapeutic biologic | 42 |
| Biologic | 3 |
| In vitro diagnostic reagent | 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
79 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Diquafosol Sodium Eye Drops | 4 | 3 | 5 |
| 2 | Tapentadol Hydrochloride Tablets | 3 | 1 | 0 |
| 3 | Lactulose Oral Solution | 2 | 2 | 34 |
| 4 | 二甲双胍恩格列净片(I) · No verified English name | 2 | 2 | 2 |
| 5 | Morinidazole and Sodium Chloride Injection | 2 | 2 | 9 |
| 6 | Vortioxetine Hydrobromide Tablets | 2 | 2 | 10 |
| 7 | Potassium Chloride Granules | 2 | 2 | 4 |
| 8 | Mecobalamin Tablets | 2 | 2 | 16 |
| 9 | Dopamine Hydrochloride Injection | 2 | 2 | 3 |
| 10 | Brimonidine Tartrate Eye Drops | 2 | 2 | 4 |
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
227 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shanxi Ren Yuan Tang Pharma Co., Ltd. romanized | 13 | 13 | 0 |
| 2 | Lan Yun Zhi He Bio Technology Co., Ltd. romanized | 8 | 7 | 0 |
| 3 | Novartis Pharma Schweiz AG | 7 | 4 | 0 |
| 4 | Hainan Xu Wo Pharma Co., Ltd. romanized | 6 | 6 | 0 |
| 5 | Qi Lu An Ti Pharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 6 | AstraZeneca AB | 6 | 5 | 0 |
| 7 | Hainan Zhong Wang Medical Technology Kai Fa Co., Ltd. romanized | 6 | 2 | 0 |
| 8 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized | 5 | 5 | 2 |
| 9 | Kang Zhi Pharma Co., Ltd. romanized | 5 | 3 | 0 |
| 10 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 5 | 2 | 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
116 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/12/20Import · Class 1 | A24110He注射液 · No verified English nameJXHL2300318 | Lipigon Pharmaceuticals AB; Leaderna Therapeutics Ltd |
| 2023/12/20Import · Class 1 | Zibotentan达格列净片 · No verified English nameJXHL2300317 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2023/12/20Import · Class 1 | Zibotentan达格列净片 · No verified English nameJXHL2300316 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2023/12/20Generic · Class 3 | Pentoxifylline InjectionCYHS2303537 | Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized |
| 2023/12/20Generic · Class 3 | 注射用比阿培南/氯化钠注射液 · No verified English nameCYHS2303536 | Hunan Ke Lun Pharmaceutical Co., Ltd. romanized |
| 2023/12/20Generic · Class 3 | Dopamine Hydrochloride InjectionCYHS2303534 | Hunan Hai Shi Biopharmaceuticals Co., Ltd. romanized; Kang Pu Pharma Co., Ltd. romanized |
| 2023/12/20New drug · Class 1.1 | 芪参颗粒 · No verified English nameCXZL2300074 | Beijing Tong Ren Tang Technology Development Co., Ltd. Pharmaceutical Factory romanized |
| 2023/12/20New drug · Class 1 | K1注射液 · No verified English nameCXSL2300872 | Jiangsu Kang He Biopharmaceutical Co., Ltd. romanized |
| 2023/12/20New drug · Class 1 | 注射用MK-2870 · No verified English nameCXSL2300871 | Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized |
| 2023/12/20New drug · Class 2.2 | LPC-008 口溶膜 · No verified English nameCXHL2301421 | Hainan Zhong Wang Medical Technology Kai Fa Co., Ltd. romanized |
| 2023/12/20New drug · Class 2.2 | LPC-008 口溶膜 · No verified English nameCXHL2301420 | Hainan Zhong Wang Medical Technology Kai Fa Co., Ltd. romanized |
| 2023/12/20New drug · Class 2.2 | LPC-008 口溶膜 · No verified English nameCXHL2301419 | Hainan Zhong Wang Medical Technology Kai Fa Co., Ltd. romanized |
| 2023/12/20New drug · Class 2.3 | LH-2103胶囊 · No verified English nameCXHL2301418 | Jiangsu Lianhuan Pharmaceutical Co.,Ltd. |
| 2023/12/19Import · Class 2.4 | 琥珀酸瑞波西利片 · No verified English nameJXHS2300126 | Novartis Pharma Schweiz AG; Novartis Singapore Pharmaceutical Manufacturing Pte. Ltd.; Beijing Novartis Pharma Co. Ltd. |
| 2023/12/19Generic · Class 3 | 盐酸肾上腺素注射液 · No verified English nameCYHS2303523 | Yang Zhou Zhong Bao Pharma Co., Ltd. romanized |
| 2023/12/19Generic · Class 3 | Cetitizine Hydrochloride Oral SolutionCYHS2303519 | Chongqing Jian Neng Pharmaceuticals Kai Fa Co., Ltd. romanized; Sichuan Jian Neng Pharmaceutical Co., Ltd. romanized |
| 2023/12/19Generic · Class 3 | Cetitizine Hydrochloride Oral SolutionCYHS2303518 | Chongqing Jian Neng Pharmaceuticals Kai Fa Co., Ltd. romanized; Sichuan Jian Neng Pharmaceutical Co., Ltd. romanized |
| 2023/12/19Generic · Class 3 | Olprinone Hydrochloride InjectionCYHS2303511 | Hainan Huluwa Pharmaceutical Group Co., Ltd. |
| 2023/12/19Generic · Class 3 | Isoniazid InjectionCYHS2303510 | Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized |
| 2023/12/19Generic · Class 3 | Ibuprofen GranulesCYHS2303506 | Shandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanized |
| 2023/12/19Generic · Class 3 | Famotidine InjectionCYHS2303505 | Fujian Tian Quan Pharma Co., Ltd. romanized; Sichuan Hong Ming Bo Si Pharma Co., Ltd. romanized |
| 2023/12/19Generic · Class 3 | Levofloxacin Oral SolutionCYHS2303504 | Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized |
| 2023/12/19Generic · Class 3 | Nicorandil for InjectionCYHS2303502 | Jilin Jin Sheng Pharmaceutical Co., Ltd. romanized |
| 2023/12/19Generic · Class 3 | Nicorandil for InjectionCYHS2303501 | Jilin Jin Sheng Pharmaceutical Co., Ltd. romanized |
| 2023/12/19Generic · Class 3 | Minoxidil LinimentCYHS2303498 | Sheng Jia (Bin Hai) Biopharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2023/12/19Generic · Class 3 | 盐酸毛果芸香碱滴眼液 · No verified English nameCYHL2300155 | Nanjing Healthnice Pharmaceutical Technology Co., Ltd |
| 2023/12/19New drug · Class 1.2 | 注射用羟基红花黄色素A · No verified English nameCXZS2300027 | Yue Kang Pharma Group Co., Ltd. romanized |
| 2023/12/19New drug · Class 1.2 | 羟基红花黄色素A · No verified English nameCXZS2300026 | Guangzhou Yue Kang Biopharmaceutical Co., Ltd. romanized |
| 2023/12/19New drug · Class 3.3 | 阿达木单抗注射液 · No verified English nameCXSS2300100 | Wuhan Bio Zhi Pin Research Institute Co., Ltd. romanized |
| 2023/12/19New drug · Class 1 | TQB2450注射液 · No verified English nameCXSL2300870 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
86 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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