YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 343 drug applications between 17 October 2024 and 23 October 2024 (data as of 14 November 2026 06:00). Of these, generic applications numbered 91, covering 73 drug names.
2024/10/17 – 2024/10/23
- New acceptances this week
- 343
- Drugs with new generic filings (by drug name, de-duplicated)
- 73
- 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
343filings, 91 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 151 |
| Generic | 91 |
| New drug | 61 |
| Import | 24 |
| Unspecified | 14 |
| Import re-registration | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 191 |
| TCM | 70 |
| Therapeutic biologic | 61 |
| Biologic | 11 |
| Prophylactic biologic | 10 |
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
73 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Bumetanide Injection | 3 | 2 | 13 |
| 2 | 匹伐他汀钙口崩片 · No verified English name | 3 | 1 | 0 |
| 3 | Bilastine Oral Solution | 2 | 2 | 8 |
| 4 | Metoclopramide Hydrochloride Injection | 2 | 2 | 6 |
| 5 | Lactulose Oral Solution | 2 | 1 | 34 |
| 6 | Tacrolimus Sustained-release Capsules | 2 | 1 | 6 |
| 7 | Perampanel Tablets | 2 | 1 | 2 |
| 8 | Olmesartan Medoxomil Orally Disintegrating Tablets | 2 | 1 | 0 |
| 9 | Levocarnitine Oral Solution | 2 | 1 | 9 |
| 10 | Lamotrigine Extended Release Tablets | 2 | 1 | 0 |
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
220 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Novo Nordisk A/S | 10 | 1 | 0 |
| 2 | AstraZeneca AB | 7 | 4 | 0 |
| 3 | Eli Lilly and Company | 7 | 2 | 0 |
| 4 | Shenyang Dong Xin Pharma Co., Ltd. romanized | 6 | 6 | 0 |
| 5 | Guizhou Yi Bai Pharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 6 | Shaanxi Sun Si Miao Gao Xin Pharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 7 | Beijing Bai Yi Wu You Technology Development Co., Ltd. romanized | 4 | 3 | 0 |
| 8 | Name not romanized | 4 | 3 | 0 |
| 9 | Bayer AG | 4 | 2 | 0 |
| 10 | MSD Merck Sharp & Dohme AG | 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
128 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/10/23Import · Class 1 | ADI-001 · No verified English nameJXSL2400202 | Adicet Therapeutics Inc.; Shanghai Adicet Biotechnology Co. Ltd. |
| 2024/10/23Import · Class 2.2 | 注射用Belantamab mafodotin · No verified English nameJXSL2400201 | GlaxoSmithKline Trading Services Limited; GlaxoSmithKline (China) Investment Co. Limited |
| 2024/10/23Import · Class 1 | Itepekimab注射液 · No verified English nameJXSL2400200 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd. |
| 2024/10/23Import · Class 1 | Frexalimab注射液 · No verified English nameJXSL2400199 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd. |
| 2024/10/23Generic · Class 3 | Famotidine InjectionCYHS2403583 | Shi Yao Yin Hu Pharmaceutical Co., Ltd. romanized |
| 2024/10/23Generic · Class 3 | Methocarbamol InjectionCYHS2403582 | Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized; Shijiazhuang Kai Da Bio Gong Cheng Co., Ltd. romanized |
| 2024/10/23Generic · Class 3 | Levocetirizine dihydrochloride Oral SolutionCYHS2403576 | Wen Ling Shi Innovation Biopharmaceuticals Technology Co., Ltd. romanized; Wan Bang De Pharmaceutical Group Co., Ltd. romanized |
| 2024/10/23Generic · Class 3 | 左羟丙哌嗪糖浆 · No verified English nameCYHS2403575 | Nanjing Heng Dao Pharmaceuticals Technology Co., Ltd. romanized; Hunan Jia Heng Pharmaceutical Co., Ltd. romanized |
| 2024/10/23Generic · Class 3 | Minoxidil LinimentCYHS2403574 | Xi Shi Lan (Nan Yang) Pharma Co., Ltd. romanized |
| 2024/10/23Generic · Class 3 | Minoxidil LinimentCYHS2403573 | Xi Shi Lan (Nan Yang) Pharma Co., Ltd. romanized |
| 2024/10/23Generic · Class 3 | Olmesartan Medoxomil Orally Disintegrating TabletsCYHS2403569 | Beijing Foyou Pharma CO.,LTD |
| 2024/10/23Generic · Class 3 | Olmesartan Medoxomil Orally Disintegrating TabletsCYHS2403568 | Beijing Foyou Pharma CO.,LTD |
| 2024/10/23Generic · Class 3 | Diprophylline InjectionCYHS2403563 | Shanghai He Feng Pharmaceutical Co., Ltd. romanized |
| 2024/10/23Generic · Class 3 | Bilastine Oral SolutionCYHL2400209 | Shanghai Bo Zhi Yan Xin Drug Research Co., Ltd. romanized |
| 2024/10/23Generic · Class 3 | Acotiamide Hydrochloride TabletsCYHL2400208 | Nanjing Healthnice Pharmaceutical Technology Co., Ltd |
| 2024/10/23New drug · Class 1 | BM230冻干制剂 · No verified English nameCXSL2400722 | Suzhou Bo Ao Ming Sai Biopharmaceutical Co., Ltd. romanized |
| 2024/10/23New drug · Class 1.3 | BW-201 (Adj 1) · No verified English nameCXSL2400721 | Beijing Bai Yi Wu You Technology Development Co., Ltd. romanized |
| 2024/10/23New drug · Class 1.3 | BW-201(Adj1) · No verified English nameCXSL2400720 | Beijing Bai Yi Wu You Technology Development Co., Ltd. romanized |
| 2024/10/23New drug · Class 1.3 | BW-201 (Adj 2) · No verified English nameCXSL2400719 | Beijing Bai Yi Wu You Technology Development Co., Ltd. romanized |
| 2024/10/23New drug · Class 1.3 | BW-201 (Adj 2) · No verified English nameCXSL2400718 | Beijing Bai Yi Wu You Technology Development Co., Ltd. romanized |
| 2024/10/23New drug · Class 1 | CM313(SC)注射液 · No verified English nameCXSL2400717 | Kang Nuo Ya Biopharmaceuticals Technology (Chengdu) Co., Ltd. romanized |
| 2024/10/23New drug · Class 1 | 康太替尼颗粒 · No verified English nameCXHS2400110 | Shou Yao Holding (Beijing) Co., Ltd. romanized; Beijing SL Pharmaceutical Co., Ltd. |
| 2024/10/23New drug · Class 1 | 康太替尼颗粒 · No verified English nameCXHS2400109 | Shou Yao Holding (Beijing) Co., Ltd. romanized; Beijing SL Pharmaceutical Co., Ltd. |
| 2024/10/23New drug · Class 1 | VSA012注射液 · No verified English nameCXHL2401125 | Wei Ya Zhen Bio Technology (Suzhou) Co., Ltd. romanized |
| 2024/10/23New drug · Class 2.2 | B0110 · No verified English nameCXHL2401124 | Guangzhou Di Qi Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/10/22Import · Class 1 | RO7790121注射液 · No verified English nameJXSL2400198 | F. Hoffmann-La Roche Ltd. |
| 2024/10/22Generic · Class 3 | Sodium Nitroprusside InjectionCYHS2403556 | Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized |
| 2024/10/22Generic · Class 3 | 地氯雷他定口服溶液 · No verified English nameCYHS2403554 | Wen Ling Shi Innovation Biopharmaceuticals Technology Co., Ltd. romanized; Wan Bang De Pharmaceutical Group Co., Ltd. romanized |
| 2024/10/22Generic · Class 3 | Indobufen TabletsCYHS2403553 | Shijiazhuang Long Ze Pharmaceutical Co., Ltd. romanized |
| 2024/10/22Generic · Class 3 | Bilastine Oral SolutionCYHS2403551 | Anhui Si Huan Ke Bao Pharmaceutical 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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