YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 260 drug applications between 6 June 2024 and 12 June 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 88, covering 67 drug names.
2024/06/06 – 2024/06/12
- New acceptances this week
- 260
- 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
260filings, 88 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 101 |
| Generic | 88 |
| New drug | 44 |
| Import | 14 |
| Unspecified | 7 |
| Import re-registration | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 187 |
| TCM | 32 |
| Therapeutic biologic | 32 |
| Prophylactic biologic | 6 |
| 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
67 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Procaterol Hydrochloride Solution for Inhalation | 4 | 3 | 2 |
| 2 | Isavuconazonium Sulfate for Injection | 2 | 2 | 15 |
| 3 | Nicardipine Hydrochloride Injection | 2 | 2 | 13 |
| 4 | Nalfurafine Hydrochloride OD Tablets | 2 | 2 | 0 |
| 5 | 丁酸氯维地平注射用乳剂 · No verified English name | 2 | 1 | 0 |
| 6 | Vonoprazan Fumarate Tablets | 2 | 1 | 60 |
| 7 | Empagliflozin Tablets | 2 | 1 | 18 |
| 8 | Lacosamide Injection | 2 | 1 | 0 |
| 9 | Amisulpride Injection | 2 | 1 | 1 |
| 10 | Methotrexate Injection | 2 | 1 | 11 |
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
166 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Qin Huang Dao Ai Hui Pharma Co., Ltd. romanized | 6 | 6 | 0 |
| 2 | Jilin Heng Xing Technology Pharmaceutical Co., Ltd. romanized | 6 | 5 | 0 |
| 3 | Shanghai Yi Feng Bio Technology Co., Ltd. romanized | 6 | 1 | 0 |
| 4 | Henan Sheng Bai Quan Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 5 | AbbVie Inc. | 5 | 2 | 0 |
| 6 | Novartis Pharma Schweiz AG | 5 | 2 | 0 |
| 7 | Hainan Ai Ke Pharmaceutical Co., Ltd. romanized | 4 | 4 | 4 |
| 8 | Qinghai Lu Kang Da Di Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 9 | Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanized | 4 | 2 | 0 |
| 10 | Bai Ji Shen Zhou (Suzhou) Bio Technology 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
93 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/06/12Import · Class 1 | Ulixacaltamide缓释片 · No verified English nameJXHL2400136 | Praxis Precision Medicines; Tenacia Biotechnology (Shanghai) Co. Ltd |
| 2024/06/12Import · Class 1 | Ulixacaltamide缓释片 · No verified English nameJXHL2400135 | Praxis Precision Medicines; Tenacia Biotechnology (Shanghai) Co. Ltd |
| 2024/06/12Import · Class 1 | Ulixacaltamide缓释片 · No verified English nameJXHL2400134 | Praxis Precision Medicines; Tenacia Biotechnology (Shanghai) Co. Ltd |
| 2024/06/12Generic · Class 3 | Dexrazoxane for InjectionCYHS2401772 | Shanghai Xu Dong Hai Pu Pharma Co., Ltd. romanized |
| 2024/06/12Generic · Class 3 | Ferrous Succinate TabletsCYHS2401771 | Anhui Jia He Pharma Co., Ltd. romanized |
| 2024/06/12Generic · Class 3 | Norepinephrine Bitartrate InjectionCYHS2401769 | Zhejiang Bo Xiao Biopharmaceutical Co., Ltd. romanized |
| 2024/06/12Generic · Class 3 | Multiple Electrolyte Additive For InjectionCYHS2401763 | Beijing Min Kang Bai Cao Pharmaceuticals Technology Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized |
| 2024/06/12Generic · Class 3 | 丁酸氯维地平注射用乳剂 · No verified English nameCYHS2401756 | CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD. |
| 2024/06/12Generic · Class 3 | 丁酸氯维地平注射用乳剂 · No verified English nameCYHS2401755 | CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD. |
| 2024/06/12Generic · Class 3 | Procaterol Hydrochloride Solution for InhalationCYHS2401753 | Beijing Hai Bu Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Fu Rui Xi Pharma Co., Ltd. romanized |
| 2024/06/12Generic · Class 3 | Digoxin InjectionCYHS2401746 | Hainan Wei Jian Pharma Co., Ltd. romanized; Shanghai Xin Yi Jin Zhu Pharma Co., Ltd. romanized |
| 2024/06/12Generic · Class 3 | Bupivacaine Hydrochloride InjectionCYHS2401745 | Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized |
| 2024/06/12Generic · Class 3 | Amisulpride InjectionCYHL2400109 | Shanxi Yang He Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/06/12Generic · Class 3 | Amisulpride InjectionCYHL2400108 | Shanxi Yang He Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/06/12Generic · Class 3 | Meloxicam injectionCYHL2400107 | Zhejiang Sheng Zhao Drug Technology Co., Ltd. romanized |
| 2024/06/12Generic · Class 3 | Relugolix TabletsCYHL2400106 | Beijing Hai Bu Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/06/12Generic · Class 3 | Ferrous Sulfate Extended-release TabletsCYHL2400105 | Jilin Tian Heng Pharma Co., Ltd. romanized |
| 2024/06/12New drug · Class 1.1 | 参苓溃康颗粒 · No verified English nameCXZL2400032 | Beijing Ying Ke Rui Innovation Pharmaceuticals Co., Ltd. romanized |
| 2024/06/12New drug · Class 1 | 注射用KJ103 · No verified English nameCXSL2400378 | Shanghai Bao Ji Pharma Co., Ltd. romanized |
| 2024/06/12New drug · Class 1 | 注射用BB-1701 · No verified English nameCXSL2400377 | Bai Li Si Kang Biopharmaceuticals (Hangzhou) Co., Ltd. romanized |
| 2024/06/12New drug · Class 1 | SYS6010 · No verified English nameCXSL2400376 | Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized |
| 2024/06/12New drug · Class 1 | BC011抗体注射液 · No verified English nameCXSL2400375 | Bao Chuan Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2024/06/12New drug · Class 1 | 注射用RC88 · No verified English nameCXSL2400374 | Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized |
| 2024/06/12New drug · Class 1 | 注射用莱古比星 · No verified English nameCXHL2400594 | Shanghai Qin He Li Biopharmaceuticals Technology Co., Ltd. romanized |
| 2024/06/12New drug · Class 1 | 注射用莱古比星 · No verified English nameCXHL2400593 | Shanghai Qin He Li Biopharmaceuticals Technology Co., Ltd. romanized |
| 2024/06/12New drug · Class 1 | ATG-037 · No verified English nameCXHL2400592 | Shanghai De Qi Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/06/12New drug · Class 1 | BGB-43395片 · No verified English nameCXHL2400591 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2024/06/12New drug · Class 1 | BGB-43395片 · No verified English nameCXHL2400590 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2024/06/12New drug · Class 1 | BGB-43395片 · No verified English nameCXHL2400589 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2024/06/12New drug · Class 2.4 | 注射用西罗莫司(白蛋白结合型) · No verified English nameCXHL2400588 | Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized |
63 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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