YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 421 drug applications between 4 December 2024 and 10 December 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 121, covering 79 drug names.
2024/12/04 – 2024/12/10
- New acceptances this week
- 421
- Drugs with new generic filings (by drug name, de-duplicated)
- 79
- Accepted this week, now under review
- 7
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
421filings, 121 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 194 |
| Generic | 121 |
| New drug | 69 |
| Import | 19 |
| Unspecified | 11 |
| Import re-registration | 5 |
| Drug-device combination | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 272 |
| TCM | 69 |
| Therapeutic biologic | 68 |
| Biologic | 8 |
| In vitro diagnostic reagent | 2 |
| Prophylactic biologic | 2 |
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
79 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Vonoprazan Fumarate Tablets | 8 | 4 | 60 |
| 2 | Lactulose Oral Solution | 5 | 1 | 34 |
| 3 | Ambroxol Hydrochloride Oral Solution | 4 | 1 | 46 |
| 4 | Oxcarbazepine Extended-release Tablets | 3 | 1 | 0 |
| 5 | Procaterol Hydrochloride Granules | 3 | 1 | 2 |
| 6 | Upadacitinib Sustained-release Tablets | 2 | 2 | 43 |
| 7 | Levocarnitine Oral Solution | 2 | 2 | 9 |
| 8 | Isavuconazonium Sulfate for Injection | 2 | 2 | 15 |
| 9 | Sodium Hyaluronate Eye Drops | 2 | 2 | 30 |
| 10 | Mupirocin Ointment | 2 | 2 | 30 |
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
249 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized | 9 | 1 | 0 |
| 2 | Heilongjiang Sheng Bu Jia Tang Pharma Co., Ltd. romanized | 8 | 8 | 0 |
| 3 | Jiangxi Qing Feng Pharma Co., Ltd. romanized | 7 | 6 | 0 |
| 4 | Ren He Yi Kang Group Co., Ltd. romanized | 7 | 3 | 2 |
| 5 | Ya Bao Pharma Group Co., Ltd. romanized | 6 | 6 | 0 |
| 6 | Zhejiang Heng Yan Pharmaceuticals Technology Co., Ltd. romanized | 6 | 4 | 5 |
| 7 | Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 6 | 2 | 0 |
| 8 | Jiangxi Ke Lun Pharma Co., Ltd. romanized | 6 | 2 | 0 |
| 9 | Novo Nordisk A/S | 5 | 3 | 0 |
| 10 | Shaanxi Xing Bang Pharma Co., Ltd. romanized | 5 | 1 | 5 |
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
122 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/12/10Import · Class 2.2 | 帕博利珠单抗注射液 · No verified English nameJXSL2400235 | Merck Sharp & Dohme LLC; MSD R&D(China) Co. Ltd |
| 2024/12/10Generic · Class 3 | Ferrous Succinate TabletsCYHS2404279 | Chi Feng Gu De Pharma Co., Ltd. romanized; Zhejiang Nord Pharmaceutical Co., Ltd |
| 2024/12/10Generic · Class 3 | Ketamine Hydrochloride InjectionCYHS2404278 | Guo Yao Group Gong Ye Co., Ltd. Lang Fang Branch romanized |
| 2024/12/10Generic · Class 3 | Potassium Aspartate InjectionCYHS2404277 | Hainan Hui Tong Biopharmaceuticals Technology Co., Ltd. romanized; Shandong Bei Da Gao Ke Hua Tai Pharmaceutical Co., Ltd. romanized |
| 2024/12/10Generic · Class 3 | Potassium Aspartate InjectionCYHS2404276 | Hainan Hui Tong Biopharmaceuticals Technology Co., Ltd. romanized; Shandong Bei Da Gao Ke Hua Tai Pharmaceutical Co., Ltd. romanized |
| 2024/12/10Generic · Class 3 | Clindamycin Palmitate Hydrochloride GranulesCYHS2404260 | Guangzhou Da Guang Pharmaceutical Co., Ltd. romanized; Hubei Wei Sen Pharmaceutical Co., Ltd. romanized |
| 2024/12/10Generic · Class 3 | 盐酸纳美芬注射液 · No verified English nameCYHS2404257 | NANJING ZENKOM PHARMACEUTICAL CO.,LTD. |
| 2024/12/10Generic · Class 3 | 贝美前列素涂剂 · No verified English nameCYHL2400252 | Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/12/10Generic · Class 3 | 贝美前列素涂剂 · No verified English nameCYHL2400251 | Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/12/10New drug · Class 1 | IMD101注射液 · No verified English nameCXSL2400843 | Shanghai Ying Mai De Medical Technology Co., Ltd. romanized |
| 2024/12/10New drug · Class 1 | 重组人源化抗BTLA单克隆抗体注射液 · No verified English nameCXSL2400842 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized |
| 2024/12/10New drug · Class 1 | JS015注射液 · No verified English nameCXSL2400841 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized |
| 2024/12/10New drug · Class 1 | JS007注射液 · No verified English nameCXSL2400840 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized |
| 2024/12/10New drug · Class 2.2 | 注射用MK-2870 · No verified English nameCXSL2400839 | Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized |
| 2024/12/10New drug · Class 1 | 9MW2821 · No verified English nameCXSL2400838 | Mai Wei (Shanghai) Bio Technology Co., Ltd. romanized |
| 2024/12/10New drug · Class 1 | 注射用JS207 · No verified English nameCXSL2400837 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized |
| 2024/12/10New drug · Class 2.2 | SYHX2011 · No verified English nameCXHS2400128 | CSPC OUYI PHARMACEUTICAL CO., LTD. |
| 2024/12/10New drug · Class 1 | KPG-818胶囊 · No verified English nameCXHL2401343 | Kang Pu Biopharmaceuticals Technology (Hefei) Co., Ltd. romanized |
| 2024/12/10New drug · Class 1 | KPG-818胶囊 · No verified English nameCXHL2401342 | Kang Pu Biopharmaceuticals Technology (Hefei) Co., Ltd. romanized |
| 2024/12/10New drug · Class 2.1; 2.2; 2.4 | ADLS1026注射液 · No verified English nameCXHL2401341 | Zhen Ao Jin Yin Hua Pharma Co., Ltd. romanized |
| 2024/12/10New drug · Class 1 | ADC189颗粒 · No verified English nameCXHL2401340 | Jia Xing An Di Kang Bio Technology Co., Ltd. romanized |
| 2024/12/10New drug · Class 1 | SAR107375E 片 · No verified English nameCXHL2401339 | Beijing Lian Xin Pharma Co., Ltd. romanized |
| 2024/12/10New drug · Class 1 | SAR107375E 片 · No verified English nameCXHL2401338 | Beijing Lian Xin Pharma Co., Ltd. romanized |
| 2024/12/10New drug · Class 1 | CS12088片 · No verified English nameCXHL2401337 | Chengdu Wei Xin Pharma Co., Ltd. romanized |
| 2024/12/10New drug · Class 2.3 | RHYK2015 · No verified English nameCXHL2401336 | Ren He Yi Kang Group Co., Ltd. romanized |
| 2024/12/10New drug · Class 1 | CS12088片 · No verified English nameCXHL2401335 | Chengdu Wei Xin Pharma Co., Ltd. romanized |
| 2024/12/10New drug · Class 2.3 | RHYK2015 · No verified English nameCXHL2401334 | Ren He Yi Kang Group Co., Ltd. romanized |
| 2024/12/10New drug · Class 2.1; 2.2; 2.4 | RFUS-301注射剂 · No verified English nameCXHL2401333 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2024/12/10New drug · Class 1 | HRS-6213注射液 · No verified English nameCXHL2401332 | Tianjin Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2024/12/09Generic · Class 3 | Zoledronic Acid InjectionCYHS2404256 | Zhejiang Kang Ji Er Pharma Co., Ltd. romanized |
92 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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