YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 173 drug applications between 6 December 2022 and 12 December 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 38, covering 30 drug names.
2022/12/06 – 2022/12/12
- New acceptances this week
- 173
- Drugs with new generic filings (by drug name, de-duplicated)
- 30
- 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
173filings, 38 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 80 |
| Generic | 38 |
| New drug | 27 |
| Import re-registration | 16 |
| Import | 9 |
| Unspecified | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 138 |
| Therapeutic biologic | 27 |
| TCM | 8 |
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
30 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 | Tedizolid Phosphate Tablets | 2 | 2 | 1 |
| 3 | Pregabalin Extended release Tablets | 2 | 1 | 13 |
| 4 | Lenalidomide Capsules | 2 | 1 | 3 |
| 5 | Flomoxef Sodium for Injection | 2 | 1 | 9 |
| 6 | Oseltamivir Phosphate Capsules | 2 | 1 | 39 |
| 7 | Elagolix Sodium Tablets | 2 | 1 | 2 |
| 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
95 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Sichuan Hong Ming Bo Si Pharma Co., Ltd. romanized | 12 | 8 | 0 |
| 2 | Shandong Wei Gao Shu Xue Technology Zhuang Bei Co., Ltd. romanized | 11 | 2 | 0 |
| 3 | Janssen Research & Development LLC | 8 | 4 | 0 |
| 4 | Fresenius Kabi AB | 6 | 1 | 0 |
| 5 | Beijing Shuo Bai Pharmaceuticals Technology Co., Ltd. romanized | 5 | 1 | 0 |
| 6 | Hubei Hui Hai Pharmaceuticals Technology Research Institute Co., Ltd. romanized | 4 | 3 | 0 |
| 7 | Shanghai Joint Sai Er Bio Gong Cheng Co., Ltd. romanized | 4 | 1 | 0 |
| 8 | Atlantic Laboratories Corporation Ltd. | 3 | 1 | 0 |
| 9 | Pfizer Inc. | 3 | 1 | 0 |
| 10 | Santen Pharmaceutical Co. Ltd. | 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
50 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 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 |
| 2022/12/09Generic · Class 3 | Gallium[68Ga ] Dotatate InjectionCYHL2200110 | Yuan Zi Gao Ke Co., Ltd. romanized |
| 2022/12/09Generic · Class 3 | Kit For The Preparation Of Gallium Ga 68 Dotatate InjectionCYHL2200109 | Yuan Zi Gao Ke Co., Ltd. romanized |
| 2022/12/09New drug · Class 1 | 重组人CD80突变体-Fc融合蛋白注射液 · No verified English nameCXSL2200595 | Xuan Zhu Bio Technology Co., Ltd. romanized; Beijing Xuan Zhu Kang Ming Bio Technology Co., Ltd. romanized |
| 2022/12/09New drug · Class 1 | SG1906注射液 · No verified English nameCXSL2200594 | Zhong Sheng Shang Jian Biopharmaceuticals (Hangzhou) Co., Ltd. romanized |
| 2022/12/09New drug · Class 1 | DBM-1152A吸入溶液 · No verified English nameCXHL2200934 | Beijing Shuo Bai Pharmaceuticals Technology Co., Ltd. romanized; Anhui Shuo Bai Pharmaceutical Co., Ltd. romanized |
| 2022/12/09New drug · Class 1 | DBM-1152A吸入溶液 · No verified English nameCXHL2200933 | Beijing Shuo Bai Pharmaceuticals Technology Co., Ltd. romanized; Anhui Shuo Bai Pharmaceutical Co., Ltd. romanized |
| 2022/12/09New drug · Class 1 | DBM-1152A吸入溶液 · No verified English nameCXHL2200932 | Beijing Shuo Bai Pharmaceuticals Technology Co., Ltd. romanized; Anhui Shuo Bai Pharmaceutical Co., Ltd. romanized |
| 2022/12/09New drug · Class 1 | DBM-1152A吸入溶液 · No verified English nameCXHL2200931 | Beijing Shuo Bai Pharmaceuticals Technology Co., Ltd. romanized; Anhui Shuo Bai Pharmaceutical Co., Ltd. romanized |
| 2022/12/09New drug · Class 1 | DBM-1152A吸入溶液 · No verified English nameCXHL2200930 | Beijing Shuo Bai Pharmaceuticals Technology Co., Ltd. romanized; Anhui Shuo Bai Pharmaceutical Co., Ltd. romanized |
20 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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