YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 106 drug applications between 24 January 2023 and 30 January 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 33, covering 29 drug names.
2023/01/24 – 2023/01/30
- New acceptances this week
- 106
- Drugs with new generic filings (by drug name, de-duplicated)
- 29
- 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
106filings, 33 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 37 |
| Generic | 33 |
| New drug | 28 |
| Import re-registration | 6 |
| Import | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 86 |
| Therapeutic biologic | 12 |
| TCM | 5 |
| Prophylactic biologic | 3 |
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
29 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Olaparib Tablets | 2 | 1 | 0 |
| 2 | Levocarnitine Injection | 2 | 1 | 4 |
| 3 | Amisulpride Injection | 2 | 1 | 1 |
| 4 | Potassium Chloride Granules | 2 | 1 | 4 |
| 5 | Epalrestat Tablets | 1 | 1 | 1 |
| 6 | Diclofenac Sodium Enteric-coated Tablets | 1 | 1 | 2 |
| 7 | 吉非替尼片 · No verified English name | 1 | 1 | 1 |
| 8 | 地氯雷他定口服溶液 · No verified English name | 1 | 1 | 26 |
| 9 | Doxofylline Injection | 1 | 1 | 5 |
| 10 | Olmesartan Medoxomil and Hydrochlorothiazide Tablets | 1 | 1 | 3 |
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 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 5 | 2 | 0 |
| 2 | Ke Di Biopharmaceuticals (Wuxi) Co., Ltd. romanized | 4 | 1 | 0 |
| 3 | Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized | 3 | 2 | 0 |
| 4 | Ai Ti Ya (Shanghai) Pharmaceutical Co., Ltd. romanized | 3 | 1 | 0 |
| 5 | Hainan Huluwa Pharmaceutical Group Co., Ltd. | 2 | 2 | 2 |
| 6 | Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized | 2 | 2 | 0 |
| 7 | A. Menarini GmbH | 2 | 1 | 0 |
| 8 | Kyowa Kirin Co. Ltd. | 2 | 1 | 0 |
| 9 | Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized | 2 | 1 | 2 |
| 10 | Haerbin Song He Pharmaceutical Co., Ltd. romanized | 2 | 1 | 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
45 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/01/30Import · Class 1 | 碘[131I]-IPA注射液 · No verified English nameJXHL2300014 | Telix International Pty Ltd; Grand Pharmaceutical (China) Co. Ltd. |
| 2023/01/30Generic · Class 3 | Carbocisteine Oral SolutionCYHS2300247 | Jian Min Pharma Group Co., Ltd. romanized |
| 2023/01/30Generic · Class 3 | Entecavir oral solutionCYHS2300245 | Hainan Quan Xing Pharmaceutical Co., Ltd. romanized |
| 2023/01/30Generic · Class 3 | 地氯雷他定口服溶液 · No verified English nameCYHS2300240 | Ya Bao Pharma Sichuan Pharmaceutical Co., Ltd. romanized |
| 2023/01/30Generic · Class 3 | Amisulpride InjectionCYHL2300011 | Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/01/30Generic · Class 3 | Amisulpride InjectionCYHL2300010 | Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/01/30New drug · Class 2.2; 2.4 | 孟鲁司特钠凝胶 · No verified English nameCXHL2300124 | Ai Ti Ya (Shanghai) Pharmaceutical Co., Ltd. romanized |
| 2023/01/30New drug · Class 2.2 | 孟鲁司特钠凝胶 · No verified English nameCXHL2300123 | Ai Ti Ya (Shanghai) Pharmaceutical Co., Ltd. romanized |
| 2023/01/30New drug · Class 2.2; 2.4 | 孟鲁司特钠凝胶 · No verified English nameCXHL2300122 | Ai Ti Ya (Shanghai) Pharmaceutical Co., Ltd. romanized |
| 2023/01/30New drug · Class 1 | P29注射液 · No verified English nameCXHL2300121 | Zhejiang He Ze Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/01/29Generic · Class 3 | 磷酸奥司他韦干糖浆 · No verified English nameCYHS2300236 | Hunan Tian Ji Cao Tang Pharmaceutical Co., Ltd. romanized |
| 2023/01/29Generic · Class 3 | 布洛芬混悬滴剂 · No verified English nameCYHS2300235 | Hainan Wan Wei Pharmaceutical Co., Ltd. romanized |
| 2023/01/29Generic · Class 3 | Famotidine InjectionCYHS2300234 | Chongqing Yao Gu Pharmaceutical Co., Ltd. romanized; Tai Ji Group Sichuan Tai Ji Pharmaceutical Co., Ltd. romanized |
| 2023/01/29Generic · Class 3 | Oxytocin InjectionCYHS2300230 | Shanxi Wei Qi Da Guang Ming Pharmaceutical Co., Ltd. romanized |
| 2023/01/29Generic · Class 3 | Potassium Chloride GranulesCYHS2300228 | Zhuhai Shi Hui Tong Da Pharmaceuticals Co., Ltd. romanized; HAINAN HUALON PHARMACEUTICAL CO.,LTD |
| 2023/01/29Generic · Class 3 | Potassium Chloride GranulesCYHS2300227 | Zhuhai Shi Hui Tong Da Pharmaceuticals Co., Ltd. romanized; HAINAN HUALON PHARMACEUTICAL CO.,LTD |
| 2023/01/29Generic · Class 3 | Indocyaninegreen for InjectionCYHS2300225 | Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. |
| 2023/01/29Generic · Class 3 | Epalrestat TabletsCYHS2300224 | Chengdu Brilliant Pharmaceutical Co., Ltd. |
| 2023/01/29Generic · Class 3 | 镥[177Lu]氧奥曲肽注射液 · No verified English nameCYHL2300009 | Yuan Zi Gao Ke Co., Ltd. romanized |
| 2023/01/29Generic · Class 3 | Flurbiprofen PatchesCYHL2300008 | Hunan Jiudian Pharmaceutical Co., Ltd |
| 2023/01/29New drug · Class 3.3 | 雷珠单抗注射液 · No verified English nameCXSS2300004 | Qilu Pharmaceutical Co., Ltd. |
| 2023/01/29New drug · Class 1 | 注射用RC118 · No verified English nameCXSL2300065 | Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized |
| 2023/01/29New drug · Class 1 | CM310重组人源化单克隆抗体注射液 · No verified English nameCXSL2300064 | Kang Nuo Ya Biopharmaceuticals Technology (Chengdu) Co., Ltd. romanized |
| 2023/01/29New drug · Class 3.3 | 吸附破伤风疫苗 · No verified English nameCXSL2300063 | Beijing Min Hai Bio Technology Co., Ltd. romanized |
| 2023/01/29New drug · Class 1 | 盐酸佐利替尼片 · No verified English nameCXHS2300020 | Jiangsu Chen Tai Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/01/29New drug · Class 1 | 盐酸佐利替尼片 · No verified English nameCXHS2300019 | Jiangsu Chen Tai Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/01/29New drug · Class 1 | HSK7653片 · No verified English nameCXHS2300018 | Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized; Sichuan Hai Si Ke Pharmaceutical Co., Ltd. romanized |
| 2023/01/29New drug · Class 1 | HSK7653片 · No verified English nameCXHS2300017 | Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized; Sichuan Hai Si Ke Pharmaceutical Co., Ltd. romanized |
| 2023/01/29New drug · Class 1 | SPH4336片 · No verified English nameCXHL2300120 | Shanghai Pharmaceuticals Group Co., Ltd. romanized |
| 2023/01/29New drug · Class 1 | TQB3616胶囊 · No verified English nameCXHL2300119 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
15 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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