YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 382 drug applications between 8 November 2024 and 14 November 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 115, covering 76 drug names.
2024/11/08 – 2024/11/14
- New acceptances this week
- 382
- Drugs with new generic filings (by drug name, de-duplicated)
- 76
- Accepted this week, now under review
- 8
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
382filings, 115 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 172 |
| Generic | 115 |
| New drug | 69 |
| Import | 13 |
| Unspecified | 7 |
| Import re-registration | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 276 |
| TCM | 54 |
| Therapeutic biologic | 39 |
| Prophylactic biologic | 11 |
| In vitro diagnostic reagent | 1 |
| 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
76 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Vonoprazan Fumarate Tablets | 4 | 2 | 60 |
| 2 | Propranolol Hydrochloride Injection | 4 | 2 | 4 |
| 3 | Fluoxetine Hydrochloride Oral Solution | 4 | 1 | 0 |
| 4 | Isavuconazonium Sulfate for Injection | 3 | 3 | 15 |
| 5 | Glucosamine Sulfate Capsules | 3 | 3 | 51 |
| 6 | Nicergoline Tablets | 3 | 2 | 1 |
| 7 | Brexpiprazole Tablets | 3 | 1 | 31 |
| 8 | Sodium sulfate, magnesium sulfate, and potassium chloride Tablets | 2 | 2 | 2 |
| 9 | Formoterol Fumarate Inhalation Solution | 2 | 2 | 5 |
| 10 | Bisoprolol Fumarate and Amlodipine Besylate Tablets | 2 | 2 | 9 |
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
236 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Jin Zhou Fu Shou Tang Pharmaceuticals Technology Co., Ltd. romanized | 14 | 13 | 0 |
| 2 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 7 | 2 | 0 |
| 3 | Wuhan Bio Zhi Pin Research Institute Co., Ltd. romanized | 6 | 4 | 0 |
| 4 | Celgene Corporation | 6 | 1 | 0 |
| 5 | Chengdu Di Kang Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 6 | Beijing Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized | 5 | 2 | 0 |
| 7 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized | 5 | 2 | 0 |
| 8 | Chengdu Brilliant Pharmaceutical Co., Ltd. | 4 | 3 | 1 |
| 9 | Xi Zhou Pharmaceuticals Technology (Zhejiang) Co., Ltd. romanized | 4 | 3 | 0 |
| 10 | Qilu Pharmaceutical Co., Ltd. | 4 | 3 | 2 |
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
125 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/11/14Import · Class 1 | 注射用MK-2400 · No verified English nameJXSL2400222 | Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd. |
| 2024/11/14Import · Class 2.2 | 帕博利珠单抗注射液 · No verified English nameJXSL2400221 | Merck Sharp & Dohme LLC; MSD R&D(China)Co. Ltd. |
| 2024/11/14Import · Class 1 | Itepekimab注射液 · No verified English nameJXSL2400220 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd. |
| 2024/11/14Generic · Class 3 | Latamoxef Sodium for InjectionCYHS2403909 | Hainan Brilliant Pharmaceutical Co., Ltd. |
| 2024/11/14Generic · Class 3 | Latamoxef Sodium for InjectionCYHS2403908 | Hainan Brilliant Pharmaceutical Co., Ltd. |
| 2024/11/14Generic · Class 3 | 维生素B6注射液 · No verified English nameCYHS2403905 | Kang Pu Pharma Co., Ltd. romanized |
| 2024/11/14Generic · Class 3 | Cefmetazole Sodium for InjectionCYHS2403901 | Anhui Jie Xi Pharmaceuticals Co., Ltd. romanized; Shenyang San Jiu Pharma Co., Ltd. romanized |
| 2024/11/14Generic · Class 3 | Cefmetazole Sodium for InjectionCYHS2403900 | Anhui Jie Xi Pharmaceuticals Co., Ltd. romanized; Shenyang San Jiu Pharma Co., Ltd. romanized |
| 2024/11/14Generic · Class 3 | Sodium Bicarbonate InjectionCYHS2403899 | Beijing Min Kang Bai Cao Pharmaceuticals Technology Co., Ltd. romanized; Wuhan Fu Xing Bio Pharma Co., Ltd. romanized |
| 2024/11/14Generic · Class 3 | Propranolol Hydrochloride InjectionCYHS2403897 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2024/11/14Generic · Class 3 | Propranolol Hydrochloride InjectionCYHS2403896 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2024/11/14Generic · Class 3 | Thioctic Acid TabletsCYHS2403894 | Shandong Lu Ning Pharma Co., Ltd. romanized |
| 2024/11/14Generic · Class 3 | Thioctic Acid TabletsCYHS2403893 | Shandong Lu Ning Pharma Co., Ltd. romanized |
| 2024/11/14Generic · Class 3 | Ketorolac Trometamol TabletsCYHS2403892 | Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized |
| 2024/11/14Generic · Class 3 | Brexpiprazole TabletsCYHL2400226 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2024/11/14Generic · Class 3 | Brexpiprazole TabletsCYHL2400225 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2024/11/14Generic · Class 3 | Brexpiprazole TabletsCYHL2400224 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2024/11/14Generic · Class 3 | 伏环孢素软胶囊 · No verified English nameCYHL2400223 | Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized |
| 2024/11/14New drug · Class 1.1 | 柴芩宁神颗粒 · No verified English nameCXZL2400078 | Shanxi Sheng Zhong Pharmaceuticals Research Institute (Shanxi Sheng Zhong Hospital) romanized |
| 2024/11/14New drug · Class 3.3 | 流感病毒裂解疫苗 · No verified English nameCXSS2400122 | Wuhan Bio Zhi Pin Research Institute Co., Ltd. romanized |
| 2024/11/14New drug · Class 3.3 | 流感病毒裂解疫苗 · No verified English nameCXSS2400121 | Wuhan Bio Zhi Pin Research Institute Co., Ltd. romanized |
| 2024/11/14New drug · Class 1 | AK129注射液 · No verified English nameCXSL2400776 | Kang Fang Hui Ke (Shanghai) Bio Co., Ltd. romanized |
| 2024/11/14New drug · Class 1 | GC310腺相关病毒注射液 · No verified English nameCXSL2400775 | Beijing Jin Lan Ji Yin Technology Co., Ltd. romanized |
| 2024/11/14New drug · Class 1 | GC310腺相关病毒注射液 · No verified English nameCXSL2400774 | Beijing Jin Lan Ji Yin Technology Co., Ltd. romanized |
| 2024/11/14New drug · Class 1 | ICG318 CAR-T细胞注射液 · No verified English nameCXSL2400773 | Song He Mian Yi Bio Medical (Shenzhen) Co., Ltd. romanized |
| 2024/11/14New drug · Class 2.2; 2.4 | 葡萄糖缓释颗粒 · No verified English nameCXHL2401236 | Beijing Ke Xin Bi Cheng Pharmaceuticals Technology Development Co., Ltd. romanized |
| 2024/11/14New drug · Class 1 | NEP018片 · No verified English nameCXHL2401235 | Shenzhen Hai Wang Pharmaceuticals Technology Research Institute Co., Ltd. romanized |
| 2024/11/14New drug · Class 1 | BG-60366片 · No verified English nameCXHL2401234 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2024/11/14New drug · Class 1 | BG-60366片 · No verified English nameCXHL2401233 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2024/11/14New drug · Class 2.2 | 司美格鲁肽注射液 · No verified English nameCXHL2401232 | Hainan Zhong He Pharma Co., Ltd. romanized |
95 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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