YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 290 drug applications between 1 December 2023 and 7 December 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 65, covering 52 drug names.
2023/12/01 – 2023/12/07
- New acceptances this week
- 290
- Drugs with new generic filings (by drug name, de-duplicated)
- 52
- Accepted this week, now under review
- 1
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
290filings, 65 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 131 |
| Generic | 65 |
| New drug | 53 |
| Import | 23 |
| Unspecified | 10 |
| Import re-registration | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 197 |
| Therapeutic biologic | 52 |
| TCM | 33 |
| Biologic | 7 |
| 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
52 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 盐酸左沙丁胺醇雾化吸入溶液 · No verified English name | 3 | 1 | 2 |
| 2 | 阿普米司特片 · No verified English name | 3 | 1 | 3 |
| 3 | Diprophylline Injection | 2 | 2 | 7 |
| 4 | 甘油磷酸钠注射液 · No verified English name | 2 | 2 | 7 |
| 5 | Agomelatine Tablets | 2 | 2 | 8 |
| 6 | Folic acid injection | 2 | 1 | 1 |
| 7 | Potassium Chloride Granules | 2 | 1 | 4 |
| 8 | Loxoprofen Sodium Patches | 2 | 1 | 30 |
| 9 | Dopamine Hydrochloride Injection | 2 | 1 | 3 |
| 10 | Trazodone Hydrochloride Tablets | 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
177 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shanxi Zhen Dong Pharmaceutical Co., Ltd. romanized | 10 | 10 | 0 |
| 2 | medac Gesellschaft für klinische Spezialpr?parate mbH | 8 | 1 | 0 |
| 3 | Janssen Research & Development LLC | 7 | 5 | 0 |
| 4 | Novo Nordisk A/S | 7 | 2 | 0 |
| 5 | Hainan Ying Da Run Ze Pharma Co., Ltd. romanized | 6 | 6 | 0 |
| 6 | AstraZeneca AB | 6 | 3 | 0 |
| 7 | Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized | 5 | 4 | 5 |
| 8 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 5 | 2 | 0 |
| 9 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 4 | 2 | 0 |
| 10 | Zhuhai Lian Bang Pharmaceutical Co., Ltd. Zhong Shan Branch romanized | 4 | 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
89 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/12/07Import · Class 3.1 | 莫妥珠单抗注射液 · No verified English nameJXSS2300087 | Roche Pharma (Schweiz) AG; Genentech Inc.; Roche (China) Holding Ltd. |
| 2023/12/07Import · Class 3.1 | 莫妥珠单抗注射液 · No verified English nameJXSS2300086 | Roche Pharma (Schweiz) AG; Genentech Inc.; Roche (China) Holding Ltd. |
| 2023/12/07Generic · Class 3 | Foscarnet Sodium InjectionCYHS2303384 | Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized |
| 2023/12/07Generic · Class 3 | Diprophylline InjectionCYHS2303383 | Ze Tian (Shandong) Pharma Co., Ltd. romanized; Shandong Qidu Pharmaceutical Co., Ltd. |
| 2023/12/07Generic · Class 3 | Dopamine Hydrochloride InjectionCYHS2303382 | Hunan Heng Sheng Pharmaceutical Co., Ltd. romanized |
| 2023/12/07Generic · Class 3 | Dopamine Hydrochloride InjectionCYHS2303381 | Hunan Heng Sheng Pharmaceutical Co., Ltd. romanized |
| 2023/12/07Generic · Class 3 | Diprophylline InjectionCYHS2303378 | Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized |
| 2023/12/07Generic · Class 3 | Metoclopramide Hydrochloride InjectionCYHS2303377 | Hubei Jin Yao Pharma Co., Ltd. romanized |
| 2023/12/07Generic · Class 3 | Proparacaine Hydrochloride Eye DropsCYHS2303373 | Shenyang Xing Qi Yan Yao Co., Ltd. romanized |
| 2023/12/07Generic · Class 3 | Methocarbamol InjectionCYHS2303372 | Beijing Min Kang Bai Cao Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized |
| 2023/12/07New drug · Class 1 | 司普奇拜单抗注射液 · No verified English nameCXSS2300090 | Chengdu Kang Nuo Xing Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/12/07New drug · Class 1 | AHT-102注射液 · No verified English nameCXSL2300845 | Guangxi Lu Gang Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/12/07New drug · Class 1 | LP-003 注射液 · No verified English nameCXSL2300844 | Tian Chen Biopharmaceuticals (Suzhou) Co., Ltd. romanized |
| 2023/12/07New drug · Class 1 | GCK-01细胞注射液 · No verified English nameCXSL2300843 | Shanghai Jing Shan Bio Technology Co., Ltd. romanized |
| 2023/12/07New drug · Class 1 | HP537片 · No verified English nameCXHL2301352 | Hai Chuang Pharma Co., Ltd. romanized |
| 2023/12/07New drug · Class 1 | HP537片 · No verified English nameCXHL2301351 | Hai Chuang Pharma Co., Ltd. romanized |
| 2023/12/07New drug · Class 1 | HSK39775片 · No verified English nameCXHL2301350 | Xizang Hai Si Ke Pharmaceutical Co., Ltd. romanized |
| 2023/12/07New drug · Class 1 | HSK39775片 · No verified English nameCXHL2301349 | Xizang Hai Si Ke Pharmaceutical Co., Ltd. romanized |
| 2023/12/07New drug · Class 2.2 | LPC-023口溶膜 · No verified English nameCXHL2301348 | Hainan Zhong Wang Medical Technology Kai Fa Co., Ltd. romanized |
| 2023/12/06Import · Class 1 | Litifilimab (BIIB059) · No verified English nameJXSL2300217 | Biogen Idec Research Limited; Biogen Biotechnology (Shanghai) Co. Ltd |
| 2023/12/06Generic · Class 3 | Trazodone Hydrochloride TabletsCYHS2303360 | Shenzhen Shi Fan Gu Pharma Co., Ltd. romanized; Jilin Tian Heng Ying Rui Pharmaceutical Co., Ltd. romanized |
| 2023/12/06Generic · Class 3 | Trazodone Hydrochloride TabletsCYHS2303359 | Shenzhen Shi Fan Gu Pharma Co., Ltd. romanized; Jilin Tian Heng Ying Rui Pharmaceutical Co., Ltd. romanized |
| 2023/12/06Generic · Class 3 | Potassium Chloride GranulesCYHS2303358 | Shijiazhuang Kang Li Pharma Co., Ltd. romanized |
| 2023/12/06Generic · Class 3 | Potassium Chloride GranulesCYHS2303357 | Shijiazhuang Kang Li Pharma Co., Ltd. romanized |
| 2023/12/06Generic · Class 3 | Folic acid injectionCYHS2303354 | Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized |
| 2023/12/06Generic · Class 3 | Folic acid injectionCYHS2303353 | Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized |
| 2023/12/06New drug · Class 1 | TNM002注射液 · No verified English nameCXSS2300092 | Zhuhai Tai Nuo Mai Bo Pharmaceutical Co., Ltd. romanized |
| 2023/12/06New drug · Class 2.2 | 注射用卡瑞利珠单抗 · No verified English nameCXSS2300091 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2023/12/06New drug · Class 1 | HB0034注射液 · No verified English nameCXSL2300841 | Shanghai Hua Ao Tai Bio Pharma Co., Ltd. romanized; Hua Bo Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2023/12/06New drug · Class 1 | HB0017注射液 · No verified English nameCXSL2300840 | Shanghai Hua Ao Tai Bio Pharma Co., Ltd. romanized; Hua Bo Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
59 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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