YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 421 drug applications between 6 December 2023 and 12 December 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 96, covering 67 drug names.
2023/12/06 – 2023/12/12
- New acceptances this week
- 421
- Drugs with new generic filings (by drug name, de-duplicated)
- 67
- 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
421filings, 96 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 219 |
| Generic | 96 |
| New drug | 67 |
| Import | 24 |
| Import re-registration | 9 |
| Unspecified | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 258 |
| TCM | 87 |
| Therapeutic biologic | 66 |
| Biologic | 6 |
| Prophylactic biologic | 3 |
| 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
67 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Morinidazole and Sodium Chloride Injection | 3 | 3 | 9 |
| 2 | 地氯雷他定口服溶液 · No verified English name | 3 | 3 | 26 |
| 3 | Levocarnitine Oral Solution | 3 | 2 | 9 |
| 4 | Minoxidil Liniment | 3 | 2 | 52 |
| 5 | 阿普米司特片 · No verified English name | 3 | 1 | 3 |
| 6 | Diprophylline Injection | 2 | 2 | 7 |
| 7 | Ceftazidime And Avibactam Sodium For Injection | 2 | 2 | 12 |
| 8 | Methocarbamol Injection | 2 | 2 | 3 |
| 9 | Agomelatine Tablets | 2 | 2 | 8 |
| 10 | Folic acid injection | 2 | 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
230 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Lan Yun Zhi He Bio Technology Co., Ltd. romanized | 43 | 34 | 0 |
| 2 | Novo Nordisk A/S | 10 | 1 | 0 |
| 3 | Tai Ji Group Sichuan Tian Cheng Pharmaceutical Co., Ltd. romanized | 8 | 8 | 0 |
| 4 | Fresenius Kabi Austria GmbH | 6 | 1 | 0 |
| 5 | ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 5 | 4 | 3 |
| 6 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 5 | 2 | 0 |
| 7 | Karuna Therapeutics Inc. | 5 | 1 | 0 |
| 8 | GlaxoSmithKline (Ireland) Limited | 4 | 3 | 0 |
| 9 | Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized | 4 | 3 | 4 |
| 10 | Zhejiang Nord Pharmaceutical Co., Ltd | 4 | 3 | 3 |
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
128 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/12/12Import · Class 3.1 | 艾沙妥昔单抗注射液 · No verified English nameJXSS2300091 | Sanofi Winthrop Industrie; Sanofi-Aventis Deutschland GmbH; Sanofi (China) Investment Co. Ltd. |
| 2023/12/12Import · Class 3.1 | 艾沙妥昔单抗注射液 · No verified English nameJXSS2300090 | Sanofi Winthrop Industrie; Sanofi-Aventis Deutschland GmbH; Sanofi (China) Investment Co. Ltd. |
| 2023/12/12Import · Class 3.1 | 注射用德曲妥珠单抗 · No verified English nameJXSS2300089 | Daiichi Sankyo Europe GmbH; Baxter Oncology GmbH; DAIICHI SANKYO(CHINA)HOLDINGS CO. LTD. |
| 2023/12/12Generic · Class 3 | 注射用头孢唑林钠/氯化钠注射液 · No verified English nameCYHS2303443 | Hunan Ke Lun Pharmaceutical Co., Ltd. romanized |
| 2023/12/12Generic · Class 3 | Fludeoxyglucose[18F] InjectionCYHS2303442 | Guangdong Gao Shang Pharmaceuticals Technology Co., Ltd. romanized; Guangdong Hui Xuan Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/12/12Generic · Class 3 | 生理氯化钠溶液 · No verified English nameCYHS2303441 | Guangdong Ke Hong Pharma Co., Ltd. romanized; Sichuan Kelun Pharmaceutical Co., Ltd. |
| 2023/12/12Generic · Class 3 | 生理氯化钠溶液 · No verified English nameCYHS2303440 | Guangdong Ke Hong Pharma Co., Ltd. romanized; Sichuan Kelun Pharmaceutical Co., Ltd. |
| 2023/12/12Generic · Class 3 | Adenosine InjectionCYHS2303438 | Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized |
| 2023/12/12Generic · Class 3 | Adenosine InjectionCYHS2303437 | Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized |
| 2023/12/12Generic · Class 3 | Norepinephrine Bitartrate InjectionCYHS2303435 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2023/12/12Generic · Class 3 | Calcium Gluconate InjectionCYHS2303434 | Jiangxi Tai Ji Li Biopharmaceuticals Technology Co., Ltd. romanized; Jiangxi Dong Fu Pharmaceutical Co., Ltd. romanized |
| 2023/12/12Generic · Class 3 | 地氯雷他定口服溶液 · No verified English nameCYHS2303428 | Shandong Jian Dao Pharmaceutical Co., Ltd. romanized |
| 2023/12/12New drug · Class 3.1 | 当归补血颗粒 · No verified English nameCXZS2300025 | Guo Yao Group Guangdong Huan Qiu Pharmaceutical Co., Ltd. romanized |
| 2023/12/12New drug · Class 3.3 | 重组人促卵泡激素注射液 · No verified English nameCXSS2300096 | Kang Ning Jie Rui (Jilin) Bio Technology Co., Ltd. romanized |
| 2023/12/12New drug · Class 3.3 | 重组人促卵泡激素注射液 · No verified English nameCXSS2300095 | Kang Ning Jie Rui (Jilin) Bio Technology Co., Ltd. romanized |
| 2023/12/12New drug · Class 2.2 | 斯鲁利单抗注射液 · No verified English nameCXSS2300094 | Shanghai Fu Hong Han Lin Biopharmaceutical Co., Ltd. romanized |
| 2023/12/12New drug · Class 1 | RJMty19注射液 · No verified English nameCXSL2300853 | Guangdong Rui Shun Bio Technology Co., Ltd. romanized |
| 2023/12/12New drug · Class 1.2 | 重组三价脊髓灰质炎疫苗(Sf-RVN细胞) · No verified English nameCXSL2300852 | Kang Xi Nuo Bio Shareholding Company romanized |
| 2023/12/12New drug · Class 1 | Taletrectinib胶囊 · No verified English nameCXHL2301379 | Bao Yuan Biopharmaceuticals Technology (Hangzhou) Co., Ltd. romanized |
| 2023/12/12New drug · Class 1 | FCN-338片 · No verified English nameCXHL2301378 | Shanghai Fu Xing Pharmaceuticals Industry Development Co., Ltd. romanized |
| 2023/12/12New drug · Class 1 | ADC189颗粒 · No verified English nameCXHL2301377 | Jia Xing An Di Kang Bio Technology Co., Ltd. romanized |
| 2023/12/12New drug · Class 1 | FCN-338片 · No verified English nameCXHL2301376 | Shanghai Fu Xing Pharmaceuticals Industry Development Co., Ltd. romanized |
| 2023/12/12New drug · Class 2.4 | Anlotinib Hydrochloride CapsulesCXHL2301375 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2023/12/12New drug · Class 2.4 | Anlotinib Hydrochloride CapsulesCXHL2301374 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2023/12/12New drug · Class 2.4 | Anlotinib Hydrochloride CapsulesCXHL2301373 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2023/12/12New drug · Class 1 | FCN-647片 · No verified English nameCXHL2301372 | Chongqing Fu Chuang Pharmaceuticals Research Co., Ltd. romanized |
| 2023/12/12New drug · Class 1 | BIOT-001片 · No verified English nameCXHL2301371 | Xiamen Bao Tai Bio Technology Co., Ltd. romanized |
| 2023/12/12New drug · Class 1 | BIOT-001片 · No verified English nameCXHL2301370 | Xiamen Bao Tai Bio Technology Co., Ltd. romanized |
| 2023/12/12New drug · Class 1 | BIOT-001片 · No verified English nameCXHL2301369 | Xiamen Bao Tai Bio Technology Co., Ltd. romanized |
| 2023/12/10New drug · Class 1 | YZJ-5799磷酸盐胶囊 · No verified English nameCXHL2301368 | Shanghai Hai Yan Pharmaceuticals Technology Co., Ltd. romanized |
98 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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