YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 420 drug applications between 17 May 2023 and 23 May 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 71, covering 46 drug names.
2023/05/17 – 2023/05/23
- New acceptances this week
- 420
- Drugs with new generic filings (by drug name, de-duplicated)
- 46
- Accepted this week, now under review
- 0
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
420filings, 71 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 254 |
| Generic | 71 |
| New drug | 63 |
| Import | 14 |
| Import re-registration | 11 |
| Unspecified | 7 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 286 |
| TCM | 89 |
| Therapeutic biologic | 40 |
| 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
46 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Roxadustat Capsules | 8 | 4 | 17 |
| 2 | Metformin Hydrochloride And Empagliflozin Extended Release Tablets | 4 | 1 | 12 |
| 3 | Ropivacaine hydrochloride injection | 4 | 1 | 5 |
| 4 | Nicorandil for Injection | 3 | 2 | 1 |
| 5 | Indobufen Tablets | 2 | 2 | 6 |
| 6 | 地氯雷他定口服溶液 · No verified English name | 2 | 2 | 26 |
| 7 | 氧(液态) · No verified English name | 2 | 2 | 13 |
| 8 | 腺苷钴胺胶囊 · No verified English name | 2 | 2 | 8 |
| 9 | 盐酸左沙丁胺醇雾化吸入溶液 · No verified English name | 2 | 1 | 2 |
| 10 | Isoprenaline Hydrochloride Injection | 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
187 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Chongqing Di Kang Zhong Yao Pharmaceutical Co., Ltd. romanized | 61 | 59 | 0 |
| 2 | Hubei Lang De Pharma Co., Ltd. romanized | 34 | 16 | 0 |
| 3 | Zhong Jia Bio Technology (Hubei Sheng) Co., Ltd. romanized | 28 | 13 | 0 |
| 4 | Ping Guang Pharmaceutical Co., Ltd. romanized | 14 | 14 | 0 |
| 5 | UCB Pharma SA | 6 | 1 | 0 |
| 6 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 5 | 2 | 0 |
| 7 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 4 | 3 | 3 |
| 8 | Liaoning Min Kang Pharmaceutical Co., Ltd. romanized | 4 | 2 | 0 |
| 9 | Shanghai Hui Lun Jiangsu Pharma Co., Ltd. romanized | 4 | 1 | 4 |
| 10 | Beijing Pu Qi Pharmaceuticals Technology 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
109 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/05/23Generic · Class 3 | Nicorandil for InjectionCYHS2301394 | Chongqing Lai Mei Pharma Co., Ltd. romanized |
| 2023/05/23Generic · Class 3 | Nicorandil for InjectionCYHS2301393 | Chongqing Lai Mei Pharma Co., Ltd. romanized |
| 2023/05/23Generic · Class 3 | Rivastigmine Hydrogen Tartrate Oral SolutionCYHS2301390 | Bai Shan Technology (Hu Zhou) Co., Ltd. romanized; Zhejiang Kai Run Pharma Co., Ltd. romanized |
| 2023/05/23Generic · Class 3 | Methocarbamol InjectionCYHS2301383 | Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized |
| 2023/05/23Generic · Class 3 | Minoxidil Topical SolutionCYHS2301380 | Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2023/05/23Generic · Class 3 | 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2301378 | Shanxi Yang He Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Guo Run Pharmaceutical Co., Ltd. romanized |
| 2023/05/23Generic · Class 3 | 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2301377 | Shanxi Yang He Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Guo Run Pharmaceutical Co., Ltd. romanized |
| 2023/05/23Generic · Class 3 | 地氯雷他定口服溶液 · No verified English nameCYHS2301371 | Nanjing Chuang Di Bio Technology Co., Ltd. romanized; Jiangsu Bei Jia Pharmaceutical Co., Ltd. romanized |
| 2023/05/23Generic · Class 3 | Acetylcysteine Oral SolutionCYHS2301370 | Anhui Mao Kang Pharma Co., Ltd. romanized; Hua Yi Pharma Technology (Anhui) Co., Ltd. romanized |
| 2023/05/23New drug · Class 2.2 | 特瑞普利单抗注射液 · No verified English nameCXSS2300037 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized; Shanghai Jun Shi Bio Gong Cheng Co., Ltd. romanized; Suzhou Zhong He Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/05/23New drug · Class 2.2 | 特瑞普利单抗注射液 · No verified English nameCXSS2300036 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized; Shanghai Jun Shi Bio Gong Cheng Co., Ltd. romanized; Suzhou Zhong He Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/05/23New drug · Class 1 | HD CD19 CAR-T细胞 · No verified English nameCXSL2300368 | Hua Dao (Shanghai) Biopharmaceuticals Co., Ltd. romanized |
| 2023/05/23New drug · Class 1 | 注射用ZG006 · No verified English nameCXSL2300367 | Name not romanized |
| 2023/05/23New drug · Class 1 | 注射用BRY812 · No verified English nameCXSL2300366 | Zhejiang Bo Rui Biopharmaceutical Co., Ltd. romanized; Hai Zheng Biopharmaceutical Co., Ltd. romanized |
| 2023/05/23New drug · Class 1 | MI078胶囊 · No verified English nameCXHL2300565 | Mai Nuo Wei (Wuxi) Pharmaceuticals Technology Co., Ltd. romanized; Nanjing Mai Nuo Wei Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/05/23New drug · Class 1 | MI078胶囊 · No verified English nameCXHL2300564 | Mai Nuo Wei (Wuxi) Pharmaceuticals Technology Co., Ltd. romanized; Nanjing Mai Nuo Wei Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/05/23New drug · Class 1 | MI078胶囊 · No verified English nameCXHL2300563 | Mai Nuo Wei (Wuxi) Pharmaceuticals Technology Co., Ltd. romanized; Nanjing Mai Nuo Wei Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/05/23New drug · Class 1 | PG-011 鼻喷雾剂 · No verified English nameCXHL2300561 | Beijing Pu Qi Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/05/23New drug · Class 1 | PG-011 鼻喷雾剂 · No verified English nameCXHL2300560 | Beijing Pu Qi Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/05/23New drug · Class 1 | PG-011 鼻喷雾剂 · No verified English nameCXHL2300559 | Beijing Pu Qi Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/05/23New drug · Class 1 | PG-011 鼻喷雾剂 · No verified English nameCXHL2300558 | Beijing Pu Qi Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/05/23New drug · Class 1 | ONC201胶囊 · No verified English nameCXHL2300557 | China Resources Sanjiu Medical & Pharmaceutical Co.,Ltd. |
| 2023/05/23New drug · Class 2.2 | 泼尼松无水吞服颗粒 · No verified English nameCXHL2300556 | Beijing Ke Xin Ju Run Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/05/22Import · Class 1 | SAR442501 · No verified English nameJXSL2300097 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd. |
| 2023/05/22Generic · Class 3 | Lincomycin InjectionCYHS2301368 | Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized |
| 2023/05/22Generic · Class 3 | Biapenem For InjectionCYHS2301365 | Anhui Pioneer Pharmaceutical Co., Ltd |
| 2023/05/22Generic · Class 3 | Methotrexate TabletsCYHS2301363 | Guo Yao Yi Xin Pharmaceutical Co., Ltd. romanized |
| 2023/05/22Generic · Class 3 | Pentazocine InjectionCYHS2301361 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED |
| 2023/05/22New drug · Class 1 | 注射用XNW28012 · No verified English nameCXSL2300365 | Shanghai Xin Nuo Wei Biopharmaceuticals Co., Ltd. romanized |
| 2023/05/22New drug · Class 1 | SM17单克隆抗体注射液 · No verified English nameCXSL2300364 | Xing Lian Pharma (Suzhou) Co., Ltd. romanized |
79 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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