YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 299 drug applications between 26 January 2023 and 1 February 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 72, covering 59 drug names.
2023/01/26 – 2023/02/01
- New acceptances this week
- 299
- Drugs with new generic filings (by drug name, de-duplicated)
- 59
- 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
299filings, 72 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 132 |
| Generic | 72 |
| New drug | 64 |
| Import re-registration | 18 |
| Import | 13 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 240 |
| Therapeutic biologic | 29 |
| TCM | 26 |
| Prophylactic biologic | 4 |
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
59 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Doxofylline Injection | 2 | 2 | 5 |
| 2 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution | 2 | 2 | 23 |
| 3 | Famotidine Injection | 2 | 2 | 8 |
| 4 | Avatrombopag Maleate Tablets | 2 | 2 | 0 |
| 5 | Acetylcysteine Granules | 2 | 1 | 4 |
| 6 | Voriconazole Tablets | 2 | 1 | 1 |
| 7 | Carbazochrome Sodium Sulfonate Injection | 2 | 1 | 1 |
| 8 | Olaparib Tablets | 2 | 1 | 0 |
| 9 | Levocarnitine Injection | 2 | 1 | 4 |
| 10 | Levofloxacin and Sodium Chloride Injection | 2 | 1 | 14 |
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
184 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shanghai Bo Lai Ke Xin Yi Pharma Co., Ltd. romanized | 8 | 1 | 0 |
| 2 | Yue Ming Tang (Shanxi) Zhong Yao Co., Ltd. romanized | 7 | 7 | 0 |
| 3 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 7 | 3 | 0 |
| 4 | Ping Guang Pharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 5 | Bracco Imaging Italia s.r.l. | 6 | 1 | 0 |
| 6 | Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | 5 | 4 | 3 |
| 7 | Sichuan Kelun Pharmaceutical Co., Ltd. | 5 | 3 | 0 |
| 8 | Zhejiang Hang Yu Pharmaceutical Co., Ltd. romanized | 5 | 2 | 0 |
| 9 | Guangzhou Bai Te Qiao Guang Medical Yong Pin Co., Ltd. romanized | 5 | 1 | 0 |
| 10 | Qilu Pharmaceutical Co., Ltd. | 4 | 3 | 1 |
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
99 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/02/01Import · Class 1 | 格罗菲妥单抗注射液 · No verified English nameJXSS2300014 | Roche Pharma (Schweiz) AG; Genentech Inc.; Roche (China) Holding Ltd. |
| 2023/02/01Import · Class 1 | SAR408701注射液 · No verified English nameJXSL2300029 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd. |
| 2023/02/01Import · Class 2.2 | Efgartigimod注射液 · No verified English nameJXSL2300028 | argenx BV; Zai Lab (Shanghai) Co. Ltd. |
| 2023/02/01Generic · Class 3 | Etoposide InjectionCYHS2300284 | Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized |
| 2023/02/01Generic · Class 3 | Minoxidil Topical SolutionCYHS2300278 | Jiangsu Ziyond Pharmaceutical Co., Ltd. |
| 2023/02/01Generic · Class 3 | Minoxidil Topical SolutionCYHS2300277 | Jiangsu Ziyond Pharmaceutical Co., Ltd. |
| 2023/02/01Generic · Class 3 | 阿瑞匹坦注射液 · No verified English nameCYHS2300273 | CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD. |
| 2023/02/01Generic · Class 3 | Carbazochrome Sodium Sulfonate InjectionCYHS2300270 | Zhong Run Pharma Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized |
| 2023/02/01Generic · Class 3 | Carbazochrome Sodium Sulfonate InjectionCYHS2300269 | Zhong Run Pharma Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized |
| 2023/02/01Generic · Class 3 | 盐酸毛果芸香碱滴眼液 · No verified English nameCYHL2300012 | Nanjing Heng Dao Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/02/01New drug · Class 1.2 | 人参总次苷片 · No verified English nameCXZL2300006 | Shanghai Hui Yu Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/02/01New drug · Class 1 | CAStem细胞注射液 · No verified English nameCXSL2300072 | Beijing Ze Hui Chen Xing Bio Technology Co., Ltd. romanized |
| 2023/02/01New drug · Class 3.3 | 吸附破伤风疫苗 · No verified English nameCXSL2300071 | Ai Mei Wei Xin Bio Pharma (Zhejiang) Co., Ltd. romanized |
| 2023/02/01New drug · Class 1 | 烟曲霉点刺液 · No verified English nameCXSL2300070 | Zhejiang Wo Wu Bio Technology Co., Ltd. romanized |
| 2023/02/01New drug · Class 1 | ZT002注射液 · No verified English nameCXSL2300069 | Beijing Zhi Tai Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/02/01New drug · Class 1 | SHR8058滴眼液 · No verified English nameCXHS2300021 | Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2023/02/01New drug · Class 2.4 | Anlotinib Hydrochloride CapsulesCXHL2300150 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2023/02/01New drug · Class 2.4 | Anlotinib Hydrochloride CapsulesCXHL2300149 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2023/02/01New drug · Class 1 | QLH12002片 · No verified English nameCXHL2300148 | Qilu Pharmaceutical Co., Ltd. |
| 2023/02/01New drug · Class 1 | QLH12002片 · No verified English nameCXHL2300147 | Qilu Pharmaceutical Co., Ltd. |
| 2023/02/01New drug · Class 2.2 | 西甲硅油口溶膜 · No verified English nameCXHL2300146 | Shandong Da Yin Hai Yang Biopharmaceutical Co., Ltd. romanized |
| 2023/02/01New drug · Class 1 | BGB-11417薄膜包衣片 · No verified English nameCXHL2300145 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2023/02/01New drug · Class 1 | BGB-11417薄膜包衣片 · No verified English nameCXHL2300144 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2023/02/01New drug · Class 1 | W1302片 · No verified English nameCXHL2300143 | Zhongguo Yi Xue Ke College Drug Research Institute romanized; Jewim Pharmaceutical (Shandong) Co., Ltd. |
| 2023/02/01New drug · Class 1 | CT-3505胶囊 · No verified English nameCXHL2300142 | Shou Yao Holding (Beijing) Co., Ltd. romanized |
| 2023/01/31Import · Class 1 | AZD7789 · No verified English nameJXSL2300027 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2023/01/31Import · Class 1 | Astegolimab注射液 · No verified English nameJXSL2300026 | F. Hoffmann-La Roche Ltd; Roche(China) Holding Ltd. |
| 2023/01/31Import · Class 1 | LOU064片 · No verified English nameJXHL2300016 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2023/01/31Import · Class 1 | LOU064片 · No verified English nameJXHL2300015 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2023/01/31Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2300267 | Liaoning Da Xiong Pharmaceutical Co., Ltd. romanized |
69 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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