YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 144 drug applications between 9 December 2022 and 15 December 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 35, covering 27 drug names.
2022/12/09 – 2022/12/15
- New acceptances this week
- 144
- Drugs with new generic filings (by drug name, de-duplicated)
- 27
- 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
144filings, 35 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 64 |
| Generic | 35 |
| New drug | 23 |
| Import re-registration | 15 |
| Import | 5 |
| Unspecified | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 120 |
| Therapeutic biologic | 18 |
| TCM | 5 |
| Prophylactic 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
27 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Latamoxef Sodium for Injection | 3 | 1 | 1 |
| 2 | Diquafosol Sodium Eye Drops | 2 | 1 | 5 |
| 3 | Pregabalin Extended release Tablets | 2 | 1 | 13 |
| 4 | Lenalidomide Capsules | 2 | 1 | 3 |
| 5 | Flomoxef Sodium for Injection | 2 | 1 | 9 |
| 6 | Urapidil Hydrochloride Injection | 2 | 1 | 6 |
| 7 | Oseltamivir Phosphate Capsules | 2 | 1 | 39 |
| 8 | 利奈唑胺干混悬剂 · No verified English name | 1 | 1 | 1 |
| 9 | Morinidazole and Sodium Chloride Injection | 1 | 1 | 9 |
| 10 | Indapamide Tablets | 1 | 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
79 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Hubei Hui Hai Pharmaceuticals Technology Research Institute Co., Ltd. romanized | 12 | 10 | 0 |
| 2 | Fresenius Kabi AB | 11 | 2 | 0 |
| 3 | Hubei Yi Ban Tian Pharmaceutical Co., Ltd. romanized | 10 | 10 | 0 |
| 4 | Janssen Research & Development LLC | 5 | 3 | 0 |
| 5 | Beijing Shuo Bai Pharmaceuticals Technology Co., Ltd. romanized | 5 | 1 | 0 |
| 6 | Sichuan Hong Ming Bo Si Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 7 | Guo Yuan Guo Yao (Guangdong) Pharmaceutical Group Co., Ltd. romanized | 3 | 3 | 0 |
| 8 | Pfizer Inc. | 3 | 1 | 0 |
| 9 | Shandong Jing Hui Bio Technology Co., Ltd. romanized | 3 | 1 | 3 |
| 10 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized | 3 | 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
41 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/12/14New drug · Class 1 | JMKX003002片 · No verified English nameCXHL2200940 | Zhejiang Hang Yu Pharmaceutical Co., Ltd. romanized; Jiangxi Guo Yao Co., Ltd. romanized |
| 2022/12/14New drug · Class 1 | JMKX003002片 · No verified English nameCXHL2200939 | Zhejiang Hang Yu Pharmaceutical Co., Ltd. romanized; Jiangxi Guo Yao Co., Ltd. romanized |
| 2022/12/14New drug · Class 1 | JMKX003002片 · No verified English nameCXHL2200938 | Zhejiang Hang Yu Pharmaceutical Co., Ltd. romanized; Jiangxi Guo Yao Co., Ltd. romanized |
| 2022/12/14New drug · Class 2.2 | 氟尿嘧啶植入剂 · No verified English nameCXHL2200937 | Hefei Ji An Pharmaceuticals Research Co., Ltd. romanized |
| 2022/12/13Generic · Class 3 | Roxatidine Acetate Hydrochloride For InjectionCYHS2202066 | Shuang He Pharma (Hainan) Co., Ltd. romanized |
| 2022/12/13New drug · Class 1 | 赫基仑赛注射液(暂定) · No verified English nameCXSS2200093 | He Yuan Bio Technology (Tianjin) Co., Ltd. romanized |
| 2022/12/13New drug · Class 3.3 | 利妥昔单抗注射液 · No verified English nameCXSS2200092 | Shanghai Bio Zhi Pin Research Institute Co., Ltd. romanized |
| 2022/12/13New drug · Class 2.2 | 注射用A型肉毒毒素 · No verified English nameCXSL2200602 | Lanzhou Bio Technology Kai Fa Co., Ltd. romanized |
| 2022/12/13New drug · Class 2.2 | 注射用A型肉毒毒素 · No verified English nameCXSL2200601 | Lanzhou Bio Technology Kai Fa Co., Ltd. romanized |
| 2022/12/10Import · Class 3.1 | 帕博利珠单抗注射液 · No verified English nameJXSS2200038 | Merck Sharp & Dohme LLC; MSD Ireland (Carlow); MSD R&D (China) Co. Ltd |
| 2022/12/10Generic · Class 3 | Adenosine InjectionCYHS2202062 | Beijing Bu Lin Bio Technology Co., Ltd. romanized; Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized |
| 2022/12/10Generic · Class 3 | Dobutamine Hydrochloride InjectionCYHS2202060 | Anhui Mao Kang Pharma Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized |
| 2022/12/10Generic · Class 3 | Latamoxef Sodium for InjectionCYHS2202057 | Shandong Jing Hui Bio Technology Co., Ltd. romanized; Shandong Run Ze Pharmaceutical Co., Ltd. romanized |
| 2022/12/10Generic · Class 3 | Latamoxef Sodium for InjectionCYHS2202056 | Shandong Jing Hui Bio Technology Co., Ltd. romanized; Shandong Run Ze Pharmaceutical Co., Ltd. romanized |
| 2022/12/10Generic · Class 3 | Latamoxef Sodium for InjectionCYHS2202055 | Shandong Jing Hui Bio Technology Co., Ltd. romanized; Shandong Run Ze Pharmaceutical Co., Ltd. romanized |
| 2022/12/10Generic · Class 3 | Aminocaproic Acid InjectionCYHS2202054 | Anhui Hai Si Mei Pharmaceuticals Co., Ltd. romanized; Jiangxi Dong Fu Pharmaceutical Co., Ltd. romanized |
| 2022/12/10Generic · Class 3 | 利奈唑胺干混悬剂 · No verified English nameCYHS2202052 | Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized |
| 2022/12/10Generic · Class 3 | Pregabalin Extended release TabletsCYHL2200112 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2022/12/10Generic · Class 3 | Pregabalin Extended release TabletsCYHL2200111 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2022/12/10New drug · Class 1 | 注射用LBL-033 · No verified English nameCXSL2200600 | Nanjing Wei Li Zhi Bo Bio Technology Co., Ltd. romanized |
| 2022/12/10New drug · Class 2.2 | 替雷利珠单抗注射液 · No verified English nameCXSL2200599 | Bai Ji Shen Zhou (Shanghai) Bio Technology Co., Ltd. romanized |
| 2022/12/10New drug · Class 1 | BGB-A445注射液 · No verified English nameCXSL2200598 | Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized |
| 2022/12/10New drug · Class 1 | LBL-007注射液 · No verified English nameCXSL2200597 | Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized |
| 2022/12/10New drug · Class 1 | EOC202注射液 · No verified English nameCXSL2200596 | Tai Zhou Yi Teng Jing Ang Pharma Co., Ltd. romanized |
| 2022/12/10New drug · Class 1 | AP301胶囊 · No verified English nameCXHL2200936 | Shanghai Li Bang Pharmaceuticals Technology Co., Ltd. romanized; Li Bang Biopharmaceuticals (Jiangsu) Co., Ltd. romanized |
| 2022/12/09Import · Class 1 | PF-07284892片 · No verified English nameJXHL2200347 | Pfizer Inc.; Pfizer Investment CO. Ltd. |
| 2022/12/09Import · Class 1 | PF-07284892片 · No verified English nameJXHL2200346 | Pfizer Inc.; Pfizer Investment CO. Ltd. |
| 2022/12/09Import · Class 1 | PF-07284892片 · No verified English nameJXHL2200345 | Pfizer Inc.; Pfizer Investment CO. Ltd. |
| 2022/12/09Generic · Class 3 | Fluorouracil InjectionCYHS2202050 | Guo Yao Yi Xin Pharmaceutical Co., Ltd. romanized; Ha Yao Group Bio Gong Cheng Co., Ltd. romanized |
| 2022/12/09Generic · Class 3 | Lidocaine Hydrochloride InjectionCYHS2202049 | Hua Run Shuang He Li Min Pharma (Jinan) Co., Ltd. romanized |
11 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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