YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 149 drug applications between 12 January 2021 and 18 January 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 24, covering 18 drug names.
2021/01/12 – 2021/01/18
- New acceptances this week
- 149
- Drugs with new generic filings (by drug name, de-duplicated)
- 18
- Accepted this week, now under review
- 2
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
149filings, 24 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 83 |
| Generic | 24 |
| New drug | 22 |
| Import | 15 |
| Import re-registration | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 127 |
| Therapeutic biologic | 19 |
| TCM | 2 |
| In vitro diagnostic reagent | 1 |
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
18 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Lacosamide Oral Solution | 2 | 2 | 0 |
| 2 | Crizotinib Capsules | 2 | 1 | 7 |
| 3 | Thiotepa for Injection | 2 | 1 | 0 |
| 4 | Duloxetine Hydrochloride Enteric Capsules | 2 | 1 | 4 |
| 5 | Citicoline Sodium Injection | 2 | 1 | 3 |
| 6 | Dabigatran Etexilate Capsules | 2 | 1 | 2 |
| 7 | Diquafosol Sodium Eye Drops | 1 | 1 | 5 |
| 8 | Desonide Cream | 1 | 1 | 0 |
| 9 | Celecoxib Capsules | 1 | 1 | 5 |
| 10 | Levosimendan Injection | 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
98 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Novartis Pharma Schweiz AG | 7 | 4 | 0 |
| 2 | Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | 6 | 1 | 0 |
| 3 | GUERBET | 5 | 1 | 0 |
| 4 | Shenzhen Xin Li Tai Pharma Co., Ltd. romanized | 4 | 1 | 0 |
| 5 | Xian Yang Sen Pharmaceutical Co., Ltd. romanized | 4 | 1 | 0 |
| 6 | AstraZeneca AB | 3 | 2 | 0 |
| 7 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized | 3 | 2 | 0 |
| 8 | Sichuan Kelun Pharmaceutical Co., Ltd. | 3 | 2 | 2 |
| 9 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 3 | 2 | 0 |
| 10 | Shanghai Shang Yao Di Yi Sheng Hua Pharma Co., Ltd. romanized | 2 | 2 | 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
36 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/01/18New drug · Class 1 | 西奥罗尼胶囊 · No verified English nameCXHL2100009 | Shenzhen Wei Xin Bio Technology Co., Ltd. romanized |
| 2021/01/16Import · Class 1 | JDQ443片 · No verified English nameJXHL2100017 | Novartis Pharma AG |
| 2021/01/16Import · Class 1 | JDQ443片 · No verified English nameJXHL2100016 | Novartis Pharma AG |
| 2021/01/16Import · Class 1 | BI 425809 片 · No verified English nameJXHL2100015 | Boehringer Ingelheim International GmbH |
| 2021/01/16New drug · Class 2 | 乙型肝炎病毒丙型肝炎病毒人类免疫缺陷病毒(1+2型)核酸检测试剂盒(PCR-荧光法) · No verified English nameCXSS2100010 | Suzhou Xin Bo Bio Technology Co., Ltd. romanized |
| 2021/01/16New drug · Class 2.4 | 重组抗EGFR人鼠嵌合单克隆抗体注射液 · No verified English nameCXSL2100015 | Bao Chuan Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2021/01/16New drug · Class 2.4 | Posaconazole Enteric-coated TabletsCXHL2100031 | Shanghai Xuan Tai Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/01/16New drug · Class 2.4 | Posaconazole Enteric-coated TabletsCXHL2100030 | Shanghai Xuan Tai Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/01/16New drug · Class 1 | SAL0104胶囊 · No verified English nameCXHL2100022 | Shenzhen Xin Li Tai Pharma Co., Ltd. romanized |
| 2021/01/15Generic · Class 3 | Thiotepa for InjectionCYHS2100063 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2021/01/15Generic · Class 3 | Thiotepa for InjectionCYHS2100062 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2021/01/15Generic · Class 3 | Citicoline Sodium InjectionCYHS2100061 | Shandong Yu Man Kun Bio Technology Co., Ltd. romanized; Jiangsu Jiu Xu Pharma Co., Ltd. romanized |
| 2021/01/15Generic · Class 3 | Citicoline Sodium InjectionCYHS2100060 | Shandong Yu Man Kun Bio Technology Co., Ltd. romanized; Jiangsu Jiu Xu Pharma Co., Ltd. romanized |
| 2021/01/15New drug · Class 1 | SY-5007片 · No verified English nameCXHL2100028 | Shou Yao Holding (Beijing) Co., Ltd. romanized |
| 2021/01/15New drug · Class 1 | SY-5007片 · No verified English nameCXHL2100027 | Shou Yao Holding (Beijing) Co., Ltd. romanized |
| 2021/01/15New drug · Class 2.2 | TTYP01片 · No verified English nameCXHL2100026 | Suzhou Ao Zong Bio Technology Co., Ltd. romanized |
| 2021/01/15New drug · Class 2.2 | 富马酸福莫特罗吸入气雾剂 · No verified English nameCXHL2100025 | Health Yuan Pharma Group Co., Ltd. romanized |
| 2021/01/15New drug · Class 2.2 | 富马酸福莫特罗吸入气雾剂 · No verified English nameCXHL2100024 | Health Yuan Pharma Group Co., Ltd. romanized |
| 2021/01/14Import · Class 3.1 | 注射用奥马珠单抗 · No verified English nameJXSS2100003 | Novartis Europharm Limited; Novartis Pharma Stein AG |
| 2021/01/14Generic · Class 3 | Magnesium Sulfate InjectionCYHS2100057 | Shanghai He Feng Pharmaceutical Co., Ltd. romanized |
| 2021/01/14New drug · Class 1 | 替戈拉生片 · No verified English nameCXHS2000047 | Shandong Luo Xin Pharma Group Co., Ltd. romanized |
| 2021/01/14New drug · Class 1 | SAL0104胶囊 · No verified English nameCXHL2100023 | Shenzhen Xin Li Tai Pharma Co., Ltd. romanized |
| 2021/01/13Import · Class 2.2 | sacituzumab govitecan · No verified English nameJXSL2100007 | Everest Medicines II (HK) Limited |
| 2021/01/13Import · Class 2.4 | Upadacitinib Sustained-release TabletsJXHS2100004 | AbbVie Deutschland GmbH & Co.KG; AbbVie Ireland NL B.V. |
| 2021/01/13Generic · Class 3 | Desonide CreamCYHS2100046 | Fu Yuan Pharma Co., Ltd. romanized |
| 2021/01/13New drug · Class 2.2 | 信迪利单抗注射液 · No verified English nameCXSS2100009 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2021/01/13New drug · Class 2.2 | 贝伐珠单抗注射液 · No verified English nameCXSS2100008 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2021/01/13New drug · Class 2.2 | 信迪利单抗注射液 · No verified English nameCXSS2100007 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2021/01/13New drug · Class 3.3 | 重组GLP-1受体激动剂注射液 · No verified English nameCXSL2100013 | Beijing Le Pu Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/01/13New drug · Class 1 | SAL0104胶囊 · No verified English nameCXHL2100021 | Shenzhen Xin Li Tai Pharma Co., Ltd. romanized |
6 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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