YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 399 drug applications between 22 December 2023 and 28 December 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 122, covering 84 drug names.
2023/12/22 – 2023/12/28
- New acceptances this week
- 399
- Drugs with new generic filings (by drug name, de-duplicated)
- 84
- 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
399filings, 122 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 169 |
| Generic | 122 |
| New drug | 73 |
| Import | 21 |
| Import re-registration | 9 |
| Unspecified | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 293 |
| TCM | 54 |
| Therapeutic biologic | 46 |
| Prophylactic 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
84 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Vonoprazan Fumarate Tablets | 4 | 2 | 60 |
| 2 | Levofloxacin and Sodium Chloride Injection | 4 | 2 | 14 |
| 3 | 注射用头孢唑肟钠 · No verified English name | 4 | 2 | 4 |
| 4 | Azilsartan Medoxomil Potassium Tablets | 4 | 2 | 35 |
| 5 | Penicillin G Sodium For Injection | 4 | 1 | 2 |
| 6 | Potassium Chloride Injection | 3 | 2 | 10 |
| 7 | Sitagliptin and Metformin Hydrochloride Extended-release Tablets | 3 | 2 | 12 |
| 8 | Ketorolac Tromethamine Injection | 3 | 2 | 4 |
| 9 | Sodium Valproate Sustained-release Tablets(I) | 2 | 2 | 4 |
| 10 | Lidocaine and Prilocaine Cream | 2 | 2 | 24 |
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
236 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Bo Rui Xin Chuang Biopharmaceuticals Technology (Wuxi) Co., Ltd. romanized | 14 | 1 | 0 |
| 2 | Shenyang Hong Yao Group Co., Ltd. romanized | 7 | 6 | 0 |
| 3 | AstraZeneca AB | 7 | 4 | 0 |
| 4 | Guangzhou Bai Yun Shan Tian Xin Pharmaceutical Co., Ltd. romanized | 7 | 4 | 0 |
| 5 | Beijing Bu Lin Bio Technology Co., Ltd. romanized | 6 | 4 | 6 |
| 6 | Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized | 6 | 2 | 0 |
| 7 | Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized | 5 | 5 | 5 |
| 8 | Chongqing Di Kang Zhong Yao Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 9 | Chengdu Bei Te Biopharmaceutical Co., Ltd. romanized | 5 | 1 | 0 |
| 10 | Ha Yao Group San Jing Qian He Pharmaceutical Co., Ltd. romanized | 4 | 4 | 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
148 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/12/28Import · Class 2.2 | Cemiplimab · No verified English nameJXSL2300237 | Regeneron Ireland Designated Activity Company (DAC); Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd |
| 2023/12/28Import · Class 3.4 | 注射用CU-20101 · No verified English nameJXSL2300236 | CKD BiO Corporation |
| 2023/12/28Import · Class 1 | M1774胶囊 · No verified English nameJXHL2300330 | Merck Healthcare KGaA; Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd |
| 2023/12/28Import · Class 1 | M1774胶囊 · No verified English nameJXHL2300329 | Merck Healthcare KGaA; Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd |
| 2023/12/28Generic · Class 3 | 吲哚美辛凝胶贴膏 · No verified English nameCYHS2303665 | Hunan Jiudian Pharmaceutical Co., Ltd |
| 2023/12/28Generic · Class 3 | Methocarbamol InjectionCYHS2303661 | Beijing Wo Bang Pharmaceuticals Technology Co., Ltd. romanized; Yin Gu Pharmaceutical Co., Ltd. romanized |
| 2023/12/28Generic · Class 3 | Loxoprofen Sodium Oral SolutionCYHS2303660 | Chongqing Huapont Pharmaceutical Co., Ltd. |
| 2023/12/28Generic · Class 3 | Penicillin G Sodium For InjectionCYHS2303653 | Kunming Nan Jiang Pharmaceutical Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized |
| 2023/12/28Generic · Class 3 | Penicillin G Sodium For InjectionCYHS2303652 | Kunming Nan Jiang Pharmaceutical Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized |
| 2023/12/28Generic · Class 3 | Penicillin G Sodium For InjectionCYHS2303651 | Kunming Nan Jiang Pharmaceutical Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized |
| 2023/12/28Generic · Class 3 | Penicillin G Sodium For InjectionCYHS2303650 | Kunming Nan Jiang Pharmaceutical Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized |
| 2023/12/28Generic · Class 3 | 地氯雷他定口服溶液 · No verified English nameCYHS2303649 | Jiangsu Dong Ke Kang De Pharma Co., Ltd. romanized; Jiangsu Ou Ge Pharmaceutical Co., Ltd. romanized |
| 2023/12/28Generic · Class 3 | 硝普钠氯化钠注射液 · No verified English nameCYHS2303648 | Shenyang Shuang Ding Pharmaceutical Co., Ltd. romanized |
| 2023/12/28Generic · Class 3 | Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2303646 | Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2023/12/28Generic · Class 3 | Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2303645 | Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2023/12/28Generic · Class 3 | Candesartan Cilexetil And Amlodipine Besylate TabletsCYHL2300165 | Jiangxi Shimei Pharmaceutical Co., Ltd |
| 2023/12/28Generic · Class 3 | 盐酸毛果芸香碱滴眼液 · No verified English nameCYHL2300164 | CSPC OUYI PHARMACEUTICAL CO., LTD. |
| 2023/12/28Generic · Class 3 | 地塞米松眼内插入剂 · No verified English nameCYHL2300163 | Beijing Ren Zhong Pharma Co., Ltd. romanized |
| 2023/12/28Generic · Class 3 | Mannitol-S InjectionCYHL2300162 | Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized |
| 2023/12/28New drug · Class 1 | 注射用BL-M05D1 · No verified English nameCXSL2300904 | Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized |
| 2023/12/28New drug · Class 1 | CUD005注射液 · No verified English nameCXSL2300903 | Sichuan Kang De Sai Medical Technology Co., Ltd. romanized |
| 2023/12/28New drug · Class 1.3 | 重组带状疱疹疫苗(CHO细胞) · No verified English nameCXSL2300902 | Anhui Zhi Fei Long Ke Ma Biopharmaceutical Co., Ltd. romanized |
| 2023/12/28New drug · Class 2.5 | 冻干人用狂犬病疫苗(Vero细胞) · No verified English nameCXSL2300901 | Shandong Yi Du Bio Technology Co., Ltd. romanized |
| 2023/12/28New drug · Class 1 | SCTB35注射液 · No verified English nameCXSL2300900 | Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized |
| 2023/12/28New drug · Class 1 | 注射用重组抗PD1/TIM3人源化双特异抗体 · No verified English nameCXSL2300899 | Shanghai Jian Xin Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/12/28New drug · Class 1 | 注射用LB4330 · No verified English nameCXSL2300898 | Shanghai Jian Xin Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/12/28New drug · Class 1 | JL18008注射液 · No verified English nameCXSL2300897 | Jie Ku (Shanghai) Biopharmaceuticals Research Co., Ltd. romanized |
| 2023/12/28New drug · Class 2.4 | TAP-1503乳膏 · No verified English nameCXHS2300119 | Shanghai Ze De Man Pharmaceuticals Technology Co., Ltd. romanized; Shanghai Xin Ya Pharma Min Xing Co., Ltd. romanized |
| 2023/12/28New drug · Class 1 | WS-0101溶液 · No verified English nameCXHL2301464 | Name not romanized |
| 2023/12/28New drug · Class 2.2 | NF2105胶囊 · No verified English nameCXHL2301463 | Shenzhen Shi Tai Li Biopharmaceuticals Co., Ltd. romanized |
118 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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