YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 200 drug applications between 25 January 2023 and 31 January 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 51, covering 42 drug names.
2023/01/25 – 2023/01/31
- New acceptances this week
- 200
- Drugs with new generic filings (by drug name, de-duplicated)
- 42
- 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
200filings, 51 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 83 |
| Generic | 51 |
| New drug | 49 |
| Import re-registration | 9 |
| Import | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 166 |
| Therapeutic biologic | 21 |
| TCM | 10 |
| Prophylactic biologic | 3 |
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
42 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 | Acetylcysteine Granules | 2 | 1 | 4 |
| 5 | Olaparib Tablets | 2 | 1 | 0 |
| 6 | Levocarnitine Injection | 2 | 1 | 4 |
| 7 | Levofloxacin and Sodium Chloride Injection | 2 | 1 | 14 |
| 8 | Amisulpride Injection | 2 | 1 | 1 |
| 9 | Potassium Chloride Granules | 2 | 1 | 4 |
| 10 | Epalrestat Tablets | 1 | 1 | 1 |
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
132 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 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 5 | 2 | 0 |
| 3 | Zhejiang Hang Yu Pharmaceutical Co., Ltd. romanized | 5 | 2 | 0 |
| 4 | Guangzhou Bai Te Qiao Guang Medical Yong Pin Co., Ltd. romanized | 5 | 1 | 0 |
| 5 | Yue Ming Tang (Shanxi) Zhong Yao Co., Ltd. romanized | 4 | 4 | 0 |
| 6 | Shandong Run Ze Pharmaceutical Co., Ltd. romanized | 4 | 1 | 0 |
| 7 | Ke Di Biopharmaceuticals (Wuxi) Co., Ltd. romanized | 4 | 1 | 0 |
| 8 | Janssen-Cilag International NV | 3 | 2 | 0 |
| 9 | Sichuan Kelun Pharmaceutical Co., Ltd. | 3 | 2 | 0 |
| 10 | Ji Chuan Pharma Group Co., Ltd. romanized | 3 | 2 | 2 |
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
74 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 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 |
| 2023/01/31Generic · Class 3 | Famotidine InjectionCYHS2300264 | Chengdu Brilliant Pharmaceutical Co., Ltd. |
| 2023/01/31Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2300263 | Anhui Xin Shi Ji Pharma Co., Ltd. romanized |
| 2023/01/31Generic · Class 3 | Polycarbophil Calcium TabletsCYHS2300253 | Zhejiang AngLiKang Pharmaceutical CO.,LTD. |
| 2023/01/31New drug · Class 1.1 | 羌防流感颗粒 · No verified English nameCXZL2300005 | Jiangsu Hai Hong Pharmaceutical Co., Ltd. romanized |
| 2023/01/31New drug · Class 1 | ASKG712注射液 · No verified English nameCXSL2300068 | Suzhou Ao Sai Kang Biopharmaceuticals Co., Ltd. romanized |
| 2023/01/31New drug · Class 1 | SHR-1819注射液 · No verified English nameCXSL2300067 | Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2023/01/31New drug · Class 2.2 | 尼妥珠单抗注射液 · No verified English nameCXSL2300066 | Bai Tai Bio Pharma Co., Ltd. romanized |
| 2023/01/31New drug · Class 1 | SAL0120片 · No verified English nameCXHL2300141 | Shenzhen Xin Li Tai Pharma Co., Ltd. romanized |
| 2023/01/31New drug · Class 1 | SAL0120片 · No verified English nameCXHL2300140 | Shenzhen Xin Li Tai Pharma Co., Ltd. romanized |
| 2023/01/31New drug · Class 2.2 | YKRH00020吸入溶液 · No verified English nameCXHL2300139 | Beijing Ying Ke Rui Innovation Drug Research Co., Ltd. romanized; Shanghai Kai Bao Pharma Co., Ltd. romanized |
| 2023/01/31New drug · Class 1 | JMKX001149片 · No verified English nameCXHL2300138 | Zhejiang Hang Yu Pharmaceutical Co., Ltd. romanized |
| 2023/01/31New drug · Class 1 | JMKX001149片 · No verified English nameCXHL2300137 | Zhejiang Hang Yu Pharmaceutical Co., Ltd. romanized |
| 2023/01/31New drug · Class 1 | JS401注射液 · No verified English nameCXHL2300136 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized; Wuxi Run Min Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/01/31New drug · Class 1 | JMKX003142片 · No verified English nameCXHL2300135 | Zhejiang Hang Yu Pharmaceutical Co., Ltd. romanized |
| 2023/01/31New drug · Class 1 | JMKX003142片 · No verified English nameCXHL2300134 | Zhejiang Hang Yu Pharmaceutical Co., Ltd. romanized |
| 2023/01/31New drug · Class 1 | JMKX003142片 · No verified English nameCXHL2300133 | Zhejiang Hang Yu Pharmaceutical Co., Ltd. romanized |
| 2023/01/31New drug · Class 1 | Hemay005片 · No verified English nameCXHL2300132 | Gan Zhou He Mei Pharma Co., Ltd. romanized |
| 2023/01/31New drug · Class 1 | KY0135片 · No verified English nameCXHL2300131 | Jiangsu Kang Yuan Pharma Co., Ltd. romanized |
| 2023/01/31New drug · Class 1 | KY0135片 · No verified English nameCXHL2300130 | Jiangsu Kang Yuan Pharma Co., Ltd. romanized |
| 2023/01/31New drug · Class 2.3 | HY-07170702软膏 · No verified English nameCXHL2300129 | Hefei Yi Gong Pharmaceuticals Co., Ltd. romanized; Hefei En Rui Te Pharma Co., Ltd. romanized |
| 2023/01/31New drug · Class 2.3 | HY-07170702软膏 · No verified English nameCXHL2300128 | Hefei Yi Gong Pharmaceuticals Co., Ltd. romanized; Hefei En Rui Te Pharma Co., Ltd. romanized |
| 2023/01/31New drug · Class 2.2 | CXG87吸入粉雾剂 · No verified English nameCXHL2300127 | Hangzhou Chang Xi Pharmaceutical Co., Ltd. romanized |
| 2023/01/31New drug · Class 1 | HSK37251片 · No verified English nameCXHL2300126 | Hai Si Ke Pharmaceutical (Mei Shan) Co., Ltd. romanized |
| 2023/01/31New drug · Class 1 | HSK37251片 · No verified English nameCXHL2300125 | Hai Si Ke Pharmaceutical (Mei Shan) Co., Ltd. romanized |
| 2023/01/30Import · Class 1 | 碘[131I]-IPA注射液 · No verified English nameJXHL2300014 | Telix International Pty Ltd; Grand Pharmaceutical (China) Co. Ltd. |
44 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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