YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 116 drug applications between 18 December 2022 and 24 December 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 19, covering 16 drug names.
2022/12/18 – 2022/12/24
- New acceptances this week
- 116
- Drugs with new generic filings (by drug name, de-duplicated)
- 16
- 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
116filings, 19 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 58 |
| Import | 20 |
| Generic | 19 |
| Unspecified | 9 |
| New drug | 8 |
| Import re-registration | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 83 |
| Therapeutic biologic | 28 |
| Prophylactic biologic | 3 |
| TCM | 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
16 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Lactulose Oral Solution | 2 | 2 | 34 |
| 2 | 氯替泼诺混悬滴眼液 · No verified English name | 2 | 1 | 1 |
| 3 | Iopromide Injection | 2 | 1 | 27 |
| 4 | Propofol Medium And Long Chain Fat Emulsion Injection | 1 | 1 | 3 |
| 5 | Tadalafil Tablets | 1 | 1 | 23 |
| 6 | Allopurinol Tablets | 1 | 1 | 4 |
| 7 | Salbutamol Sulfate Inhalation Solution | 1 | 1 | 2 |
| 8 | Palbociclib Tablets | 1 | 1 | 2 |
| 9 | Levofloxacin Injection | 1 | 1 | 1 |
| 10 | Ibuprofen Suspension | 1 | 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
64 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Hubei Yi Ban Tian Pharmaceutical Co., Ltd. romanized | 12 | 12 | 0 |
| 2 | Hangzhou Jiu Yuan Ji Yin Gong Cheng Co., Ltd. romanized | 10 | 1 | 0 |
| 3 | Shandong Wei Gao Shu Xue Technology Zhuang Bei Co., Ltd. romanized | 9 | 3 | 0 |
| 4 | An Qing Hui Yin Bi Pharmaceutical Co., Ltd. romanized | 5 | 4 | 0 |
| 5 | Microlabs | 3 | 3 | 0 |
| 6 | Amgen Inc. | 3 | 1 | 0 |
| 7 | Aspen Pharma Trading Limited | 3 | 1 | 0 |
| 8 | Otsuka Pharmaceutical Co.，Ltd. | 3 | 1 | 0 |
| 9 | Beijing Sai Sheng Pharma Co., Ltd. romanized | 3 | 1 | 0 |
| 10 | Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | 3 | 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
22 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/12/24Import · Class 3.1 | 依库珠单抗注射液 · No verified English nameJXSS2200041 | Alexion Europe SAS; Alexion Athlone Manufacturing Facility (AAMF); AstraZeneca Investment (China) Co. Ltd |
| 2022/12/24Import · Class 1 | LY3473329片 · No verified English nameJXHL2200351 | Eli Lilly and Company |
| 2022/12/24Import · Class 1 | LY3473329片 · No verified English nameJXHL2200350 | Eli Lilly and Company |
| 2022/12/23Import · Class 1 | AMG 451 · No verified English nameJXSL2200211 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd. |
| 2022/12/23Import · Class 1 | AMG 451 · No verified English nameJXSL2200210 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd. |
| 2022/12/23Import · Class 1 | AMG 451 · No verified English nameJXSL2200209 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd. |
| 2022/12/23Import · Class 1 | Cetrelimab 注射液 · No verified English nameJXSL2200208 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2022/12/23Import · Class 1 | Cetrelimab 注射液（皮下注射） · No verified English nameJXSL2200207 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2022/12/23Import · Class 1 | MEDI5752 · No verified English nameJXSL2200206 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2022/12/23New drug · Class 1 | AP017单克隆抗体注射液 · No verified English nameCXSL2200613 | An Yuan Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2022/12/23New drug · Class 1 | LK101注射液 · No verified English nameCXSL2200612 | Beijing Li Kang Sheng Ming Technology Co., Ltd. romanized |
| 2022/12/22Import · Class 1 | 仑卡奈单抗注射液 · No verified English nameJXSS2200040 | Eisai Inc.; Biogen US Corporation; Eisai China Inc. |
| 2022/12/22Import · Class 1 | 仑卡奈单抗注射液 · No verified English nameJXSS2200039 | Eisai Inc.; Biogen US Corporation; Eisai China Inc. |
| 2022/12/22New drug · Class 1 | HMI-115 · No verified English nameCXSL2200611 | He Qi Rui Pharmaceuticals (Nanjing) Co., Ltd. romanized |
| 2022/12/21Generic · Class 3 | Allopurinol TabletsCYHS2202092 | Zhejiang Pu Li Pharma Co., Ltd. romanized |
| 2022/12/21New drug · Class 1 | 重组人IL-21溶瘤痘病毒注射液（hV01） · No verified English nameCXSL2200610 | Hangzhou Kang Wan Da Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/12/21New drug · Class 1 | 注射用重组抗HER2结构域II和结构域IV双特异性抗体-MMAE偶联物 · No verified English nameCXSL2200609 | Xuan Zhu Bio Technology Co., Ltd. romanized; Beijing Xuan Zhu Kang Ming Bio Technology Co., Ltd. romanized |
| 2022/12/20Generic · Class 3 | Levofloxacin InjectionCYHS2202080 | Guo Ren Health Pharmaceutical (Beijing) Co., Ltd. romanized; Shandong Luo Xin Pharma Group Co., Ltd. romanized |
| 2022/12/20Generic · Class 3 | Potassium Chloride Oral SolutionCYHS2202079 | Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized |
| 2022/12/20New drug · Class 1.1 | 健脾益气口服液 · No verified English nameCXZL2200053 | Guangxi Zhong Pharmaceuticals University Di Yi Fu Shu Hospital (Guangxi Zhong Yi Hospital) romanized |
| 2022/12/20New drug · Class 1 | 注射用SKB410 · No verified English nameCXSL2200608 | Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized |
| 2022/12/20New drug · Class 1 | PE0116注射液 · No verified English nameCXSL2200606 | Shanghai Huai Yue Bio Technology Co., Ltd. romanized |
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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