YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 332 drug applications between 20 October 2023 and 26 October 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 106, covering 82 drug names.
2023/10/20 – 2023/10/26
- New acceptances this week
- 332
- Drugs with new generic filings (by drug name, de-duplicated)
- 82
- 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
332filings, 106 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 141 |
| Generic | 106 |
| New drug | 62 |
| Import | 12 |
| Unspecified | 6 |
| Import re-registration | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 256 |
| TCM | 47 |
| Therapeutic biologic | 26 |
| Prophylactic biologic | 2 |
| 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
82 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Oseltamivir Phosphate For Oral Suspension | 3 | 2 | 2 |
| 2 | Acetylcysteine Oral Solution | 3 | 1 | 11 |
| 3 | Nicardipine Hydrochloride Injection | 3 | 1 | 13 |
| 4 | Sodium Valproate Sustained-release Tablets(I) | 2 | 2 | 4 |
| 5 | Candesartan Cilexetil and Hydrochlorothiazide Tablets | 2 | 1 | 0 |
| 6 | Olanzapine Tablets | 2 | 1 | 4 |
| 7 | Vonoprazan Fumarate Tablets | 2 | 1 | 60 |
| 8 | Metformin Hydrochloride And Empagliflozin Extended Release Tablets | 2 | 1 | 12 |
| 9 | Tolvaptan Orally Disintegrating Tablets | 2 | 1 | 5 |
| 10 | Torsemide 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
217 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Hebei Yu Zhi Lin Pharma Co., Ltd. romanized | 8 | 8 | 0 |
| 2 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 5 | 4 | 4 |
| 3 | Jin He Zang Yao Co., Ltd. romanized | 5 | 4 | 0 |
| 4 | Li Bang Pharma (Shanghai) Co., Ltd. romanized | 5 | 1 | 0 |
| 5 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 4 | 2 | 0 |
| 6 | JANSSEN-CILAG NV | 4 | 1 | 0 |
| 7 | TRUEMED LTD. | 4 | 1 | 0 |
| 8 | Takeda Manufacturing Austria AG | 4 | 1 | 0 |
| 9 | Shanghai Shang Yao Xin Ya Pharma Co., Ltd. romanized | 4 | 1 | 0 |
| 10 | Changchun Jin Sai Pharma Co., Ltd. romanized | 4 | 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
118 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/10/26Import · Class 2.2 | 埃万妥单抗注射液 · No verified English nameJXSS2300080 | Janssen-Cilag International NV; Cilag AG; Johnson & Johnson Pharmaceutical Ltd. |
| 2023/10/26Import · Class 3.1 | 索米妥昔单抗注射液 · No verified English nameJXSS2300079 | ImmunoGen Inc.; BSP Pharmaceuticals S.p.A.; HANGZHOU ZHONGMEI HUADONG PHARMACEUTICAL CO. LTD. |
| 2023/10/26Generic · Class 3 | Oseltamivir Phosphate For Oral SuspensionCYHS2302914 | CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD. |
| 2023/10/26Generic · Class 3 | Thioctic Acid TabletsCYHS2302913 | Zhejiang Heng Yan Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2023/10/26Generic · Class 3 | Procaterol Hydrochloride Oral SolutionCYHS2302911 | Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized |
| 2023/10/26Generic · Class 3 | 腺苷钴胺胶囊 · No verified English nameCYHS2302907 | Hubei Kai An Chen Pharmaceuticals Technology Co., Ltd. romanized; Hubei Guang Ren Pharma Co., Ltd. romanized |
| 2023/10/26Generic · Class 3 | Procaterol Hydrochloride GranulesCYHS2302905 | Jiangsu Zheng Da Qing Jiang Pharmaceutical Co., Ltd. romanized |
| 2023/10/26New drug · Class 1 | LY-M001注射液 · No verified English nameCXSL2300730 | Ling Yi (Hangzhou) Bio Technology Co., Ltd. romanized |
| 2023/10/26New drug · Class 1 | AK120注射液 · No verified English nameCXSL2300729 | Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized |
| 2023/10/26New drug · Class 1 | 人脐带间充质干细胞注射液 · No verified English nameCXSL2300728 | Tian Shi Li Pharmaceuticals Group Co., Ltd. romanized |
| 2023/10/26New drug · Class 1 | EP-0146片 · No verified English nameCXHL2301170 | Chengdu Easton Biopharmaceuticals Co.,Ltd. |
| 2023/10/26New drug · Class 1 | EP-0146片 · No verified English nameCXHL2301169 | Chengdu Easton Biopharmaceuticals Co.,Ltd. |
| 2023/10/26New drug · Class 1 | EP-0146片 · No verified English nameCXHL2301168 | Chengdu Easton Biopharmaceuticals Co.,Ltd. |
| 2023/10/26New drug · Class 1 | AP303片 · No verified English nameCXHL2301167 | Li Bang Pharma (Shanghai) Co., Ltd. romanized |
| 2023/10/26New drug · Class 1 | AP303片 · No verified English nameCXHL2301166 | Li Bang Pharma (Shanghai) Co., Ltd. romanized |
| 2023/10/26New drug · Class 1 | AP303片 · No verified English nameCXHL2301165 | Li Bang Pharma (Shanghai) Co., Ltd. romanized |
| 2023/10/26New drug · Class 1 | AP303片 · No verified English nameCXHL2301164 | Li Bang Pharma (Shanghai) Co., Ltd. romanized |
| 2023/10/26New drug · Class 1 | AP303片 · No verified English nameCXHL2301163 | Li Bang Pharma (Shanghai) Co., Ltd. romanized |
| 2023/10/26New drug · Class 1 | 艾托莫德片 · No verified English nameCXHL2301162 | Jian Kuan (Suzhou) Bio Technology Co., Ltd. romanized; Zhongguo Yi Xue Ke College Drug Research Institute romanized |
| 2023/10/25Import · Class 1 | BMS-986435片 · No verified English nameJXHL2300267 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd |
| 2023/10/25Generic · Class 3 | Esomeprazole Magnesium for Delayed-release Oral SuspensionCYHS2302896 | Rui Yang Pharmaceutical Co., Ltd. romanized |
| 2023/10/25Generic · Class 3 | Potassium Chloride GranulesCYHS2302895 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2023/10/25Generic · Class 3 | Calcium Acetate TabletsCYHS2302887 | Qingdao Bai Yang Pharmaceutical Co., Ltd. romanized |
| 2023/10/25Generic · Class 3 | Tolvaptan Orally Disintegrating TabletsCYHS2302886 | Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2023/10/25Generic · Class 3 | Tolvaptan Orally Disintegrating TabletsCYHS2302885 | Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2023/10/25Generic · Class 3 | Minoxidil LinimentCYHS2302884 | Tai Kang Hai En Pharma Co., Ltd. romanized |
| 2023/10/25Generic · Class 3 | Metformin Hydrochloride And Empagliflozin Extended Release TabletsCYHS2302883 | Chengdu Di Ao Pharmaceutical Group Co., Ltd. romanized; Guangzhou Bo Si Tao Kong Shi Pharma Co., Ltd. romanized |
| 2023/10/25Generic · Class 3 | Metformin Hydrochloride And Empagliflozin Extended Release TabletsCYHS2302882 | Chengdu Di Ao Pharmaceutical Group Co., Ltd. romanized; Guangzhou Bo Si Tao Kong Shi Pharma Co., Ltd. romanized |
| 2023/10/25New drug · Class 1 | MBS314注射液 · No verified English nameCXSL2300727 | Kang Yuan Bo Chuang Bio Technology (Beijing) Co., Ltd. romanized; Beijing Tian Guang Shi Bio Technology Co., Ltd. romanized |
| 2023/10/25New drug · Class 1 | BRL03注射液 · No verified English nameCXSL2300726 | Guangzhou Bai Ji Biopharmaceutical Co., Ltd. romanized |
88 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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