YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 364 drug applications between 25 December 2023 and 31 December 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 109, covering 81 drug names.
2023/12/25 – 2023/12/31
- New acceptances this week
- 364
- Drugs with new generic filings (by drug name, de-duplicated)
- 81
- 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
364filings, 109 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 155 |
| Generic | 109 |
| New drug | 75 |
| Import | 12 |
| Import re-registration | 10 |
| Unspecified | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 281 |
| TCM | 40 |
| Therapeutic biologic | 38 |
| Prophylactic biologic | 5 |
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
81 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 注射用头孢唑肟钠 · No verified English name | 4 | 2 | 4 |
| 2 | Azilsartan Medoxomil Potassium Tablets | 4 | 2 | 35 |
| 3 | Penicillin G Sodium For Injection | 4 | 1 | 2 |
| 4 | Sitagliptin and Metformin Hydrochloride Extended-release Tablets | 3 | 2 | 12 |
| 5 | Lidocaine and Prilocaine Cream | 2 | 2 | 24 |
| 6 | Telmisartan And Amlodipine Tablets | 2 | 2 | 10 |
| 7 | 氧 · No verified English name | 2 | 2 | 15 |
| 8 | Nicorandil for Injection | 2 | 2 | 1 |
| 9 | Nefopam Hydrochloride Injection | 2 | 2 | 3 |
| 10 | Sodium Bicarbonate Injection | 2 | 2 | 10 |
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
216 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 | Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized | 8 | 7 | 7 |
| 3 | Boehringer Ingelheim International GmbH | 7 | 2 | 0 |
| 4 | Guangzhou Bai Yun Shan Tian Xin Pharmaceutical Co., Ltd. romanized | 6 | 3 | 0 |
| 5 | Beijing Si Huan Ke Bao Pharma Co., Ltd. romanized | 5 | 3 | 0 |
| 6 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 5 | 2 | 0 |
| 7 | Chengdu Bei Te Biopharmaceutical Co., Ltd. romanized | 5 | 1 | 0 |
| 8 | Jilin San Jiu Jin Fu Kang Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 9 | Ha Yao Group San Jing Qian He Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 10 | Beijing Bu Lin Bio Technology Co., Ltd. romanized | 4 | 3 | 4 |
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
141 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/12/30Import · Class 3.1 | 瑞利珠单抗注射液 · No verified English nameJXSS2300095 | Alexion Europe SAS; Alexion Pharma International Operations Limited Alexion Athlone Manufacturing Facility (AAMF); AstraZeneca Global R&D (China) Co. Ltd. |
| 2023/12/30Import · Class 3.1 | 瑞利珠单抗注射液 · No verified English nameJXSS2300094 | Alexion Europe SAS; Alexion Pharma International Operations Limited Alexion Athlone Manufacturing Facility (AAMF); AstraZeneca Global R&D (China) Co. Ltd. |
| 2023/12/30Generic · Class 3 | Levocetirizine dihydrochloride Oral SolutionCYHS2303686 | Guo Yao Group Shan Tou Jin Shi Pharmaceutical Co., Ltd. romanized |
| 2023/12/30Generic · Class 3 | Dopamine Hydrochloride InjectionCYHS2303684 | Chengdu Bai Yu Pharmaceutical Co., Ltd. romanized |
| 2023/12/30Generic · Class 3 | Dopamine Hydrochloride InjectionCYHS2303683 | Chengdu Bai Yu Pharmaceutical Co., Ltd. romanized |
| 2023/12/30Generic · Class 3 | Propranolol Hydrochloride InjectionCYHS2303682 | Fuzhou Ji Shi Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/12/30Generic · Class 3 | 维生素B6注射液 · No verified English nameCYHS2303681 | Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized; Shandong Hao Rui En Pharmaceutical Co., Ltd. romanized |
| 2023/12/30New drug · Class 3.3 | 四价流感病毒裂解疫苗 · No verified English nameCXSS2300101 | Zhejiang Tian Yuan Bio Pharma Co., Ltd. romanized |
| 2023/12/30New drug · Class 1 | CG-BM1异体人骨髓间充质干细胞注射液 · No verified English nameCXSL2300909 | Guangzhou Sai Juan Bio Technology Co., Ltd. romanized |
| 2023/12/30New drug · Class 1 | 3HP-2827片 · No verified English nameCXHL2301485 | Si Kang Rui Qi (Suzhou) Pharma Co., Ltd. romanized |
| 2023/12/30New drug · Class 1 | 3HP-2827片 · No verified English nameCXHL2301484 | Si Kang Rui Qi (Suzhou) Pharma Co., Ltd. romanized |
| 2023/12/30New drug · Class 1 | INV-1120胶囊 · No verified English nameCXHL2301483 | Fo Shan Shi Yuan Li Bio Technology Co., Ltd. romanized |
| 2023/12/30New drug · Class 1 | INV-1120胶囊 · No verified English nameCXHL2301482 | Fo Shan Shi Yuan Li Bio Technology Co., Ltd. romanized |
| 2023/12/30New drug · Class 1 | KPG-818胶囊 · No verified English nameCXHL2301481 | Kang Pu Biopharmaceuticals Technology (Hefei) Co., Ltd. romanized |
| 2023/12/30New drug · Class 1 | KPG-818胶囊 · No verified English nameCXHL2301480 | Kang Pu Biopharmaceuticals Technology (Hefei) Co., Ltd. romanized |
| 2023/12/30New drug · Class 1 | GT919胶囊 · No verified English nameCXHL2301479 | Biao Xin Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2023/12/30New drug · Class 1 | GT919胶囊 · No verified English nameCXHL2301478 | Biao Xin Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2023/12/30New drug · Class 1 | GT919胶囊 · No verified English nameCXHL2301477 | Biao Xin Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2023/12/30New drug · Class 1 | ABP-745片 · No verified English nameCXHL2301476 | Jiangsu Xin Yuan Su Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/12/30New drug · Class 1 | ABP-745片 · No verified English nameCXHL2301475 | Jiangsu Xin Yuan Su Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/12/30New drug · Class 1 | ABP-745片 · No verified English nameCXHL2301474 | Jiangsu Xin Yuan Su Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/12/30New drug · Class 1 | HX101胶囊 · No verified English nameCXHL2301473 | Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized |
| 2023/12/30New drug · Class 1 | CYH001肠溶胶囊 · No verified English nameCXHL2301472 | Beijing Cheng Yi Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/12/30New drug · Class 1 | CYH001肠溶胶囊 · No verified English nameCXHL2301471 | Beijing Cheng Yi Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/12/30New drug · Class 1 | XP-102SC胶囊 · No verified English nameCXHL2301470 | Xu Nuo Pharma (Nanjing) Co., Ltd. romanized |
| 2023/12/29Generic · Class 3 | Sodium Picosulfate, Magnesium Oxide, And Anhydrous Citric Acid Oral SolutionCYHS2303677 | Beijing Min Kang Bai Cao Pharmaceuticals Technology Co., Ltd. romanized; Tian Da Pharma (Zhuhai) Co., Ltd. romanized |
| 2023/12/29Generic · Class 3 | Metaraminol Tartrate InjectionCYHS2303676 | Wuhan Jiu An Pharma Co., Ltd. romanized; Lang Tian Pharma (Hubei) Co., Ltd. romanized |
| 2023/12/29Generic · Class 3 | Sodium Bicarbonate InjectionCYHS2303675 | Beijing Min Kang Bai Cao Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized |
| 2023/12/29Generic · Class 3 | Nicorandil for InjectionCYHS2303672 | Hebei Long Hai Pharma Co., Ltd. romanized; Hebei Yi Pin Pharmaceutical Co., Ltd. romanized |
| 2023/12/29Generic · Class 3 | Azithromycin Eye DropsCYHL2300168 | Nanjing Heng Dao Pharmaceuticals Technology Co., Ltd. romanized |
111 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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