YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 359 drug applications between 26 February 2024 and 3 March 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 57, covering 46 drug names.
2024/02/26 – 2024/03/03
- New acceptances this week
- 359
- Drugs with new generic filings (by drug name, de-duplicated)
- 46
- 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
359filings, 57 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 222 |
| Generic | 57 |
| New drug | 46 |
| Import | 17 |
| Unspecified | 12 |
| Import re-registration | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 205 |
| TCM | 99 |
| Therapeutic biologic | 51 |
| Prophylactic biologic | 3 |
| Biologic | 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
46 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Diprophylline Injection | 4 | 4 | 7 |
| 2 | Calcium Folinate Injection | 2 | 2 | 4 |
| 3 | Vonoprazan Fumarate Tablets | 2 | 1 | 60 |
| 4 | Bisoprolol Fumarate Tablets | 2 | 1 | 6 |
| 5 | Enzalutamide Tablets | 2 | 1 | 2 |
| 6 | Sildenafil Citrate Tablets | 2 | 1 | 12 |
| 7 | 盐酸维洛沙秦缓释胶囊 · No verified English name | 2 | 1 | 0 |
| 8 | 长链脂肪乳注射液(OO) · No verified English name | 2 | 1 | 0 |
| 9 | Fluvoxamine Maleate Tablets | 2 | 1 | 0 |
| 10 | Ezetimibe and Simvastatin Tablets | 1 | 1 | 4 |
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 | Shijiazhuang Yu Ze Tang Pharmaceutical Co., Ltd. romanized | 62 | 47 | 0 |
| 2 | Gansu Xin Min Hai Pharmaceutical Co., Ltd. romanized | 13 | 13 | 0 |
| 3 | EUROAPI Germany GmbH | 5 | 5 | 0 |
| 4 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 5 | 4 | 2 |
| 5 | Dr. Falk Pharma GmbH | 5 | 2 | 0 |
| 6 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 5 | 2 | 0 |
| 7 | Myokardia Inc. | 5 | 1 | 0 |
| 8 | Jilin Sheng Li Sheng Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 9 | Sichuan Kelun Pharmaceutical Co., Ltd. | 4 | 2 | 4 |
| 10 | Guo Yao Group Guizhou Biopharmaceutical Co., Ltd. romanized | 4 | 2 | 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
86 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/03/02Import · Class 3.1 | 注射用利纳西普 · No verified English nameJXSS2400016 | Kiniksa Pharmaceuticals (UK) Ltd.; Jubilant HollisterStier LLC; HANGZHOU ZHONGMEI HUADONG PHARMACEUTICALS CO. LTD |
| 2024/03/02Import · Class 1 | RO7435846片 · No verified English nameJXHL2400051 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2024/03/02Import · Class 1 | RO7435846片 · No verified English nameJXHL2400050 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2024/03/02Import · Class 1 | RO7435846片 · No verified English nameJXHL2400049 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2024/03/02Generic · Class 3 | Delafloxacin for InjectionCYHS2400746 | Jiangsu Ao Sai Kang Pharma Co., Ltd. romanized |
| 2024/03/02Generic · Class 3 | 复方电解质注射液(V) · No verified English nameCYHS2400745 | Hebei Tian Cheng Pharma Co., Ltd. romanized |
| 2024/03/02Generic · Class 3 | 盐酸维洛沙秦缓释胶囊 · No verified English nameCYHL2400050 | Jiangsu En Hua Pharma Co., Ltd. romanized; Suzhou En Hua Biopharmaceuticals Technology Co., Ltd. romanized |
| 2024/03/02Generic · Class 3 | 盐酸维洛沙秦缓释胶囊 · No verified English nameCYHL2400049 | Jiangsu En Hua Pharma Co., Ltd. romanized; Suzhou En Hua Biopharmaceuticals Technology Co., Ltd. romanized |
| 2024/03/02New drug · Class 1 | SSGJ-707注射液 · No verified English nameCXSL2400171 | Shenyang San Sheng Pharmaceutical Co., Ltd. romanized; San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized |
| 2024/03/02New drug · Class 1 | 盐酸去甲乌药碱注射液 · No verified English nameCXHS2400019 | Zhuhai Run Dou Pharmaceutical Co., Ltd. romanized |
| 2024/03/01Import · Class 2.4 | 米罗那非片 · No verified English nameJXHL2400048 | AriBio Co. Ltd.; Panacro (Hefei) Pharmaceutical Technology Co. Ltd. |
| 2024/03/01Import · Class 2.4 | 米罗那非片 · No verified English nameJXHL2400047 | AriBio Co. Ltd.; Panacro (Hefei) Pharmaceutical Technology Co. Ltd. |
| 2024/03/01Generic · Class 3 | Diprophylline InjectionCYHS2400741 | Yang Zhou Zhong Bao Pharma Co., Ltd. romanized |
| 2024/03/01Generic · Class 3 | 地氯雷他定口服溶液 · No verified English nameCYHS2400738 | Jiangsu Kai Yuan Pharma Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2024/03/01Generic · Class 3 | Oseltamivir Phosphate For Oral SuspensionCYHS2400734 | Ha Yao Group Technology Center romanized |
| 2024/03/01Generic · Class 3 | 维生素B6注射液 · No verified English nameCYHS2400733 | Hainan Yuan Ying Pharmaceuticals Technology Co., Ltd. romanized; Jiu Quan Da De Li Pharmaceutical Co., Ltd. romanized |
| 2024/03/01Generic · Class 3 | 托吡酯口服溶液 · No verified English nameCYHS2400730 | Chongqing Hua Sen Pharmaceutical Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd. |
| 2024/03/01Generic · Class 3 | Diprophylline InjectionCYHS2400728 | Liaoning Hai Shen Lian Sheng Pharmaceutical Co., Ltd. romanized; Dan Dong Yi Chuang Pharma Co., Ltd. romanized |
| 2024/03/01Generic · Class 3 | Diprophylline InjectionCYHS2400727 | Shandong Rui Yi Pharmaceuticals Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized |
| 2024/03/01Generic · Class 3 | Diprophylline InjectionCYHS2400726 | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2024/03/01New drug · Class 1.1 | 通络健脑片 · No verified English nameCXZS2400010 | Guangzhou Yue Kang Biopharmaceutical Co., Ltd. romanized |
| 2024/03/01New drug · Class 1.1 | 紫花温肺止嗽颗粒 · No verified English nameCXZS2400009 | Guangzhou Yue Kang Biopharmaceutical Co., Ltd. romanized |
| 2024/03/01New drug · Class 1 | 注射用KKD001 · No verified English nameCXSL2400170 | Shang Rao Shi Kang Ke De Bio Technology Co., Ltd. romanized |
| 2024/03/01New drug · Class 1 | RBD1016注射液 · No verified English nameCXHL2400235 | Suzhou Rui Bo Bio Technology Co., Ltd. romanized |
| 2024/03/01New drug · Class 1 | HRS-5346片 · No verified English nameCXHL2400234 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized; Beijing Sheng Di Pharmaceuticals Co., Ltd. romanized; Shanghai Tuo Jie Biopharmaceuticals Technology Co., Ltd. romanized |
| 2024/03/01New drug · Class 1 | HRS-5346片 · No verified English nameCXHL2400233 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized; Shanghai Tuo Jie Biopharmaceuticals Technology Co., Ltd. romanized; Beijing Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2024/03/01New drug · Class 1 | TQ05105片 · No verified English nameCXHL2400232 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2024/03/01New drug · Class 1 | TQ05105片 · No verified English nameCXHL2400231 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2024/02/29Import · Class 1 | Amlitelimab注射液 · No verified English nameJXSL2400054 | Sanofi-Aventis Recherche & Developpement; Sanofi (China) Investment Co. LTD |
| 2024/02/29Import · Class 1 | Amlitelimab注射液 · No verified English nameJXSL2400053 | Sanofi-Aventis Recherche & Developpement; Sanofi (China) Investment Co. LTD |
56 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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