YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 224 drug applications between 22 October 2022 and 28 October 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 50, covering 41 drug names.
2022/10/22 – 2022/10/28
- New acceptances this week
- 224
- Drugs with new generic filings (by drug name, de-duplicated)
- 41
- 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
224filings, 50 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 113 |
| Generic | 50 |
| New drug | 27 |
| Unspecified | 13 |
| Import | 13 |
| Import re-registration | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 175 |
| Therapeutic biologic | 21 |
| TCM | 15 |
| Biologic | 9 |
| Prophylactic biologic | 4 |
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
41 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Acetylcysteine Solution For Inhalation | 3 | 3 | 4 |
| 2 | Metaraminol Tartrate Injection | 2 | 2 | 2 |
| 3 | Olaparib Tablets | 2 | 1 | 0 |
| 4 | Flumazenil Injection | 2 | 1 | 2 |
| 5 | Urapidil Hydrochloride Injection | 2 | 1 | 6 |
| 6 | Ambroxol Hydrochloride Drops | 2 | 1 | 8 |
| 7 | Memantine Hydrochloride Extended-release and Donepezil Hydrochloride Capsules | 2 | 1 | 2 |
| 8 | 盐酸西替利嗪滴剂 · No verified English name | 2 | 1 | 8 |
| 9 | Acetylcysteine Injection | 1 | 1 | 53 |
| 10 | Diprophylline Injection | 1 | 1 | 7 |
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
145 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Fuzhou Ji Shi Pharmaceuticals Technology Co., Ltd. romanized | 12 | 11 | 0 |
| 2 | Hubei Mei Lin Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 3 | Chengdu Shi Hai Tong Pharma Co., Ltd. romanized | 5 | 2 | 0 |
| 4 | Li Cai Gansu Xi Feng Pharmaceutical Co., Ltd. romanized | 4 | 2 | 4 |
| 5 | Hong Jian Pharmaceutical (Shanghai) Co., Ltd. romanized | 4 | 2 | 0 |
| 6 | AstraZeneca UK Limited | 4 | 1 | 0 |
| 7 | Ai Ti Ya (Shanghai) Pharmaceutical Co., Ltd. romanized | 4 | 1 | 0 |
| 8 | Merck Sharp & Dohme LLC | 3 | 3 | 0 |
| 9 | Shanxi Yi Qing Ke Pharma Co., Ltd. romanized | 3 | 3 | 0 |
| 10 | Boehringer Ingelheim International GmbH | 3 | 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
63 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/10/28Import · Class 1 | elranatamab · No verified English nameJXSL2200188 | Pfizer Inc; Pfizer Investment CO. Ltd. |
| 2022/10/28Import · Class 1 | Aticaprant 薄膜包衣片 · No verified English nameJXHL2200317 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2022/10/28Import · Class 2.2; 2.4 | Delgocitinib乳膏 · No verified English nameJXHL2200316 | LEO Pharma A/S; LEO Pharma Consultancy (Shanghai) Company Limited |
| 2022/10/28Import · Class 2.2 | 阿塞那平透皮贴剂 · No verified English nameJXHL2200315 | LIAN HONG KONG LIMITED; Livzon (Group) Pharmaceutical Research Institute |
| 2022/10/28Import · Class 2.2 | 阿塞那平透皮贴剂 · No verified English nameJXHL2200314 | LIAN HONG KONG LIMITED; Livzon (Group) Pharmaceutical Research Institute |
| 2022/10/28Import · Class 2.2 | 阿塞那平透皮贴剂 · No verified English nameJXHL2200313 | LIAN HONG KONG LIMITED; Livzon (Group) Pharmaceutical Research Institute |
| 2022/10/28Generic · Class 3 | Ibuprofen InjectionCYHS2201847 | Hainan He Rui Pharmaceutical Co., Ltd. romanized |
| 2022/10/28Generic · Class 3 | Procaterol Hydrochloride GranulesCYHS2201846 | Anhui Bai Ao Pharma Co., Ltd. romanized; Beijing Bai Ao Pharma Co., Ltd. romanized |
| 2022/10/28Generic · Class 3 | Ambroxol Hydrochloride DropsCYHS2201844 | Li Cai Gansu Xi Feng Pharmaceutical Co., Ltd. romanized |
| 2022/10/28Generic · Class 3 | Ambroxol Hydrochloride DropsCYHS2201843 | Li Cai Gansu Xi Feng Pharmaceutical Co., Ltd. romanized |
| 2022/10/28Generic · Class 3 | Fluorouracil InjectionCYHS2201842 | Hainan Zhuo Ke Pharmaceutical Co., Ltd. romanized; Haikou Shi Pharmaceutical Factory Co., Ltd. romanized |
| 2022/10/28New drug · Class 1 | 自体淋巴细胞注射液 · No verified English nameCXSL2200546 | Beijing Kang Ai Rui Hao Bio Technology Co., Ltd. romanized |
| 2022/10/28New drug · Class 2.2 | 孟鲁司特钠凝胶 · No verified English nameCXHL2200842 | Ai Ti Ya (Shanghai) Pharmaceutical Co., Ltd. romanized |
| 2022/10/28New drug · Class 2.2 | 孟鲁司特钠凝胶 · No verified English nameCXHL2200841 | Ai Ti Ya (Shanghai) Pharmaceutical Co., Ltd. romanized |
| 2022/10/28New drug · Class 2.2; 2.4 | 孟鲁司特钠凝胶 · No verified English nameCXHL2200840 | Ai Ti Ya (Shanghai) Pharmaceutical Co., Ltd. romanized |
| 2022/10/28New drug · Class 2.2; 2.4 | 孟鲁司特钠凝胶 · No verified English nameCXHL2200839 | Ai Ti Ya (Shanghai) Pharmaceutical Co., Ltd. romanized |
| 2022/10/28New drug · Class 2.4 | 泽布替尼胶囊 · No verified English nameCXHL2200838 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2022/10/28New drug · Class 1 | 注射用HN0090 · No verified English nameCXHL2200837 | Hui Nuo Biopharmaceuticals Technology (Hangzhou) Co., Ltd. romanized; Nanjing Ming De Xin Yao Research and Development Co., Ltd. romanized |
| 2022/10/27Import · Class 3.1 | 度普利尤单抗注射液 · No verified English nameJXSL2200187 | sanofi-aventis groupe; Sanofi(China) Investment Co. LTD |
| 2022/10/27Import · Class 2.4 | Upadacitinib片 · No verified English nameJXHL2200312 | AbbVie Inc. |
| 2022/10/27Import · Class 2.4 | Upadacitinib片 · No verified English nameJXHL2200311 | AbbVie Inc. |
| 2022/10/27Generic · Class 3 | Sodium Bicarbonate Ringer’s InjectionCYHS2201838 | Shandong Hua Lu Pharmaceutical Co., Ltd. romanized |
| 2022/10/27Generic · Class 3 | Flumazenil InjectionCYHS2201837 | Guangzhou Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized |
| 2022/10/27Generic · Class 3 | Flumazenil InjectionCYHS2201836 | Guangzhou Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized |
| 2022/10/27Generic · Class 3 | Nimodipine Oral SolutionCYHS2201834 | Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2022/10/27Generic · Class 3 | Metaraminol Tartrate InjectionCYHS2201833 | Shanxi Zhen Dong Tai Sheng Pharmaceutical Co., Ltd. romanized |
| 2022/10/27New drug · Class 2.2 | 重组人乳头瘤病毒6/11/16/18型四价疫苗(汉逊酵母) · No verified English nameCXSL2200545 | Jiangsu Rui Ke Bio Technology Co., Ltd. romanized |
| 2022/10/27New drug · Class 1 | KYS202002A 注射液 · No verified English nameCXSL2200544 | Jiangsu Kang Yuan Pharma Co., Ltd. romanized |
| 2022/10/27New drug · Class 1 | HSK16149胶囊 · No verified English nameCXHS2200058 | Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized; Sichuan Hai Si Ke Pharmaceutical Co., Ltd. romanized |
| 2022/10/27New drug · Class 1 | TQB3616胶囊 · No verified English nameCXHL2200836 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
33 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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